Impact of health-related claims on the perception of other product attributes

DEFF Research Database (Denmark)

Lähteenmäki, Liisa; Lampila, Piritta; Grunert, Klaus G.

2010-01-01

countries explored consumers' perceptions of attractiveness, healthiness, naturalness, tastiness and ability to reduce risk of disease by comparing ratings of products with and without health claims. Used claims varied in their benefit, active ingredient, claim structure and framing. The results showed...... that health claims had a moderate but mostly negative impact on the perception of other product attributes; the most significant impact was decrease in perceived naturalness. Consumers could also interpret the benefits in claims as intended. The wording of the claim had only small impact on the perception...... is not likely to cause any unrealistic positive inferences in perceived product quality....

Are the predictors of work absence following a work-related injury similar for musculoskeletal and mental health claims?

Science.gov (United States)

Smith, Peter M; Black, Oliver; Keegel, Tessa; Collie, Alex

2014-03-01

To examine if the factors associated with days of absence following a work-related injury are similar for mental health versus musculoskeletal (MSK) conditions. A secondary analysis of wage replacement workers' compensation claims in the state of Victoria, Australia. We examined the relationship between individual, injury, occupational and workplace variables with days of wage replacement over the 2-year period following first day of absence from work separately for mental health claims and MSK claims using negative binomial regression models. Mental health conditions were associated with a greater number of days of absence over the 2 years following first incapacity compared to MSK conditions. Differences were observed in employment, injury and industry variables on absence from work for mental claims compared to MSK claims. Working in the agriculture, forestry, fishing and mining industries and employment with a small organisation were more strongly associated with the number of days of wage-replacement among MSK compared to mental health claims, and working in the public administration and safety, or education and training industries or being employed in a position with high time pressure were associated with greater days of wage-replacement among mental health compared to MSK claims. Predictors of days away from work in the 2 years following an injury differ for mental health versus MSK claims. Given the increasing number of mental health claims in Australia more research is required to understand differences in return-to-work for this group of claimants compared to those with physical injuries.

Influence of package and health-related claims on perception and sensory acceptability of snack bars.

Science.gov (United States)

Pinto, Vinícius Rodrigues Arruda; Freitas, Tamara Beatriz de Oliveira; Dantas, Maria Inês de Souza; Della Lucia, Suzana Maria; Melo, Laura Fernandes; Minim, Valéria Paula Rodrigues; Bressan, Josefina

2017-11-01

Concerns for health can lead to healthier food choices, especially if the consumer is well informed. This study aimed to evaluate the importance of package and health-related claims on Brazilian consumers' acceptance of snack bars. In order to evaluate package attributes, in focus groups discussions, 19 consumers chose the most important factors that influence their purchase decisions. Next, 102 consumers evaluated six commercial brands of snack bars in a three-session acceptance test: the first with no information about the product, the second containing the product package and the third with information on health-related claims associated with consumption of the bar. In general, package attributes, price and flavor were the most important factors that influence the purchase of snack bars. Health claims positively influenced consumer acceptance, but information concerning the absence of gluten and lactose did not significantly alter sensory acceptance. The presence of omega-3s, sugars, preservatives, flavorings and colorings have the potential to improve acceptability, because they were able to raise the acceptance of the seed bar, removing it from the rejection region. Protein and nut bars are not well known to the general public and the lower mean acceptance of the seed and protein bars demonstrated the need for sensorial improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effect of a health system's medical error disclosure program on gastroenterology-related claims rates and costs.

Science.gov (United States)

Adams, Megan A; Elmunzer, B Joseph; Scheiman, James M

2014-04-01

In 2001, the University of Michigan Health System (UMHS) implemented a novel medical error disclosure program. This study analyzes the effect of this program on gastroenterology (GI)-related claims and costs. This was a review of claims in the UMHS Risk Management Database (1990-2010), naming a gastroenterologist. Claims were classified according to pre-determined categories. Claims data, including incident date, date of resolution, and total liability dollars, were reviewed. Mean total liability incurred per claim in the pre- and post-implementation eras was compared. Patient encounter data from the Division of Gastroenterology was also reviewed in order to benchmark claims data with changes in clinical volume. There were 238,911 GI encounters in the pre-implementation era and 411,944 in the post-implementation era. A total of 66 encounters resulted in claims: 38 in the pre-implementation era and 28 in the post-implementation era. Of the total number of claims, 15.2% alleged delay in diagnosis/misdiagnosis, 42.4% related to a procedure, and 42.4% involved improper management, treatment, or monitoring. The reduction in the proportion of encounters resulting in claims was statistically significant (P=0.001), as was the reduction in time to claim resolution (1,000 vs. 460 days) (P<0.0001). There was also a reduction in the mean total liability per claim ($167,309 pre vs. $81,107 post, 95% confidence interval: 33682.5-300936.2 pre vs. 1687.8-160526.7 post). Implementation of a novel medical error disclosure program, promoting transparency and quality improvement, not only decreased the number of GI-related claims per patient encounter, but also dramatically shortened the time to claim resolution.

Health Claims Data Warehouse (HCDW)

Data.gov (United States)

Office of Personnel Management — The Health Claims Data Warehouse (HCDW) will receive and analyze health claims data to support management and administrative purposes. The Federal Employee Health...

Health foods and foods with health claims in Japan

International Nuclear Information System (INIS)

Ohama, Hirobumi; Ikeda, Hideko; Moriyama, Hiroyoshi

2006-01-01

The terms 'nutraceuticals' and 'dietary or food supplements' are not very popular in Japan as compared to most of other countries. However, the concept of 'functional foods', which benefits the structure and function of the human body, is known as a result of research studies initiated on the health benefits of foods in 1984. The Ministry of Education organized a national research and development project to evaluate the functionalities of various foods. Researchers from diverse scientific fields succeeded to define new functions of food, successfully incorporating the previously recognized functions of nutrition, sensory/satisfaction and physiological effects of ingredients in foods. Some of the food manufacturers and distributors unfortunately capitalized on such food functionalities to promote 'health foods' by claiming drug-like effects and violating laws. In 1991, the Ministry of Health and Welfare (MHW) now as the Ministry of Health, Labor and Welfare (MHLW) introduced a 'foods for specified health uses' (FOSHU) system, for the control of such exaggerated and misleading claims. The other reason for such enforcement is due to an increase in the population of elderly people and lifestyle-related diseases that include obesity, diabetes mellitus, high blood pressure, cerebro- and cardiovascular diseases and cancer. In 2001, a new regulatory system, 'foods with health claims' (FHC) with a 'foods with nutrient function claims' (FNFC) system and newly established FOSHU was introduced. In addition, MHLW has changed the existing FOSHU, FNFC and other systems in 2005. Such changes include the new subsystems of FOSHU such as (1) standardized FOSHU (2) qualified FOSHU and (3) disease risk reduction claims for FOSHU. In the present chapter, two guidelines that require good manufacturing practice (GMP) and self-investigative systems for ensuring the safety of raw materials used for products in the dosage forms such as capsules, tablets, etc. have been discussed. Furthermore

Updates on nutrition and health claims

Directory of Open Access Journals (Sweden)

Alejandro Perales-Albert

2013-12-01

Full Text Available There is concern about the influence of social determinants related to advertising, communication and information on the selection of food for healthy eating and safe. From this point of view, Spain created the European Regulation 1924/2006 (ER1924/2006, its aim is to ensure and promote access to safe food that benefit health and prevent information received by consumers is inaccurate, ambiguous or misleading. The aims of regulation are to prevent nutritional and attributed health claims to food without reason or if there is sufficient scientific evidence. In this sense, a group of professionals from the University of Alicante in December 2012 performed the First Day of Food and Nutrition, organized by the Center Alinua of the Faculty of Health Sciences, University of Alicante, related to updates on nutrition and health claims and its implications public health.By the interest and importance of this topic, this is a summary of the position papers from agents involved: consumers, government, food business, the gremial’s dietitian, the Academy and public health.

Country differences in the history of use of health claims and symbols

DEFF Research Database (Denmark)

Hieke, Sophie; Kuljanic, Nera; Fernandez, Laura

2016-01-01

Health-related claims and symbols are intended as aids to help consumers make informed and healthier food choices but they can also stimulate the food industry to develop food that goes hand in hand with a healthier lifestyle. In order to better understand the role that health claims and symbols...... currently have and in the future potentially can have, the objective of the CLYMBOL project (“Role of health-related claims and symbols in consumer behaviour”, Grant no 311963) is to investigate consumers’ understanding of health claims and symbols, and how they affect purchasing and consumption [1......]. As part of this endeavour, it is important to understand the history of use of claims and symbols in Europe. What have consumers been exposed to and how were these health-related messages used and discussed among the public? In this study, we interviewed key stakeholders across Europe about how health...

The EU health claim regulation in international comparison

DEFF Research Database (Denmark)

Aschemann-Witzel, Jessica

2011-01-01

Nutrition and health claims are voluntary claims on food indicating favourable nutritional content or health benefits of the food. Nutrition and health claims on food are increasingly regulated in the world market. This process is accompanied by intensive stakeholder discussions on the possible...... impact on consumer protection and food marketing effectiveness. This article reviews literature on regulations in the major food markets in comparison with the EU regulation. The focus is on identifying characteristics of regulations that are expected to have an impact on consumer protection and food...... marketing. The EU regulation is regarded as focusing relatively strongly on precaution and consumer understanding. The extent to which this hampers food innovations is in dispute. It is suggested that using marketing measures in favour of scientifically approved claims as well as stakeholder cooperation...

Statement on the conditions of use for health claims related to meal replacements for weight control

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2015-01-01

) and maintenance of body weight after weight loss (ID1418) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. Taking into account that the mechanisms by which meal replacements could exert the claimed effects were mostly related to their controlled energy content and the relatively high protein/low fat...... content, the Panel concludes that the differences in the micronutrient composition of meal replacements which would derive from changing the conditions of use from Directive 96/8/EC to Regulation (EU) 1169/2011 do not affect the scientific substantiation of health claims related to meal replacements...

Determinants of consumer understanding of health claims

DEFF Research Database (Denmark)

Grunert, Klaus G; Scholderer, Joachim; Rogeaux, Michel

2011-01-01

as safe, risky or other. In addition to the open questions on claim understanding, respondents rated a number of statements on claim interpretation for agreement and completed scales on interest in healthy eating, attitude to functional foods, and subjective knowledge on food and health. Results showed......The new EU regulation on nutrition and health claims states that claims can be permitted only if they can be expected to be understood by consumers. Investigating determinants of consumer understanding of health claims has therefore become an important topic. Understanding of a health claim...... on a yoghurt product was investigated with a sample of 720 category users in Germany. Health claim understanding was measured using open answers, which were subsequently content analysed and classified by comparison with the scientific dossier of the health claim. Based on this respondents were classified...

Consumer perceptions of nutrition and health claims

NARCIS (Netherlands)

Trijp, van H.C.M.; Lans, van der I.A.

2007-01-01

The number of food products containing extra or reduced levels of specific ingredients (e.g. extra calcium) that bring particular health benefits (e.g. stronger bones) is still increasing. Nutrition- and health-related (NH) claims promoting these ingredient levels and their health benefit differ in

Potentially Deceptive Health Nutrition-Related Advertising Claims: The Role of Inoculation in Conferring Resistance

Science.gov (United States)

Mason, Alicia M.; Miller, Claude H.

2016-01-01

Objective: This study sought to examine the efficacy of inoculation message treatments to facilitate resistance to health nutrition-related (HNR) commercial food advertising claims. Design: Data were collected across three phases extending across a 5-week period conducted over two semesters at a Midwest US university. A 2 × 3 between-subjects…

Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under Regulation (EC 1924/2006 in the area of oral health

Directory of Open Access Journals (Sweden)

Daniela Martini

2018-03-01

Clinical significance: The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims related to oral health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such health claims.

Guidance on the scientific requirements for health claims related to gut and immune function

DEFF Research Database (Denmark)

Tetens, Inge

2011-01-01

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to gut and immune function. This guidance has been drawn from scientific opinions of the NDA Panel on such health......, was subjected to public consultation (28 September 2010 to 22 October 2010), and was also discussed at a technical meeting with experts in the field on 2 December 2010 in Amsterdam....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to physical performance

DEFF Research Database (Denmark)

Tetens, Inge

The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) to draft guidance on scientific requirements for health claims related to physical performance. This guidance has been drawn from scientific opinions of the NDA Panel on such health...... claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in this area. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which...

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to gut and immune function published in 2011. Since then, the NDA Panel has completed the evaluation...... the shortcomings that prevented the substantiation of these claims. The general document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, in the light of experiences gained from the evaluation...

Health and Stress Management and Mental-health Disability Claims.

Science.gov (United States)

Marchand, Alain; Haines, Victor Y; Harvey, Steve; Dextras-Gauthier, Julie; Durand, Pierre

2016-12-01

This study examines the associations between health and stress management (HSM) practices and mental-health disability claims. Data from the Salveo study was collected during 2009-2012 within 60 workplaces nested in 37 companies located in Canada (Quebec) and insured by a large insurance company. In each company, 1 h interviews were conducted with human resources managers in order to obtain data on 63 HSM practices. Companies and workplaces were sorted into the low-claims and high-claims groups according to the median rate of the population of the insurer's corporate clients. Logistic regression adjusted for design effect and multidimensional scaling was used to analyse the data. After controlling for company size and economic sector, task design, demands control, gratifications, physical activity and work-family balance were associated with low mental-health disability claims rates. Further analyses revealed three company profiles that were qualified as laissez-faire, integrated and partially integrated approaches to HSM. Of the three, the integrated profile was associated with low mental-health disability claims rates. The results of this study provide evidence-based guidance for a better control of mental-health disability claims. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Motivation outweighs ability in explaining European consumers' use of health claims

DEFF Research Database (Denmark)

Hoefkens, Christine; Hung, Yung; Hieke, Sophie

Introduction: Health claims promise health benefits beyond basic nutrition, but their impact on food choices is largely determined by consumers’ motivation and ability to process these claims. Objectives: This study aimed at investigating the role of consumers’ motivation and ability to process....... Moreover, participants with greater objective knowledge were found to be less able to process health claims. Both types of objective knowledge were positively related. Conclusions: Motivation rather than the ability determines European consumers’ use of health claims. Therefore, food and nutrition policy...... European countries: United Kingdom, Germany, The Netherlands, Spain, Slovenia, Czech Republic, France, Denmark, Greece and Lithuania (n=5,337). Structural equation modelling was used to simultaneously estimate the strength and direction of relationships between motivation and ability to process, various...

Perception of health claims among Nordic consumers

DEFF Research Database (Denmark)

Grunert, Klaus G.; Lähteenmäki, Liisa; Boztug, Yasemin

2009-01-01

. Claims were constructed from an underlying universe combining different active ingredients (familiar, unfamiliar), type of claim (combination of information about ingredient, physiological function and health benefit), framing (positive, negative) and use of qualifier (with, without 'may'). Across pairs...... of active ingredient, physiological function and health benefit, whereas the other prefers 'short' claims consisting of the health benefit only. Results also showed that the familiar ingredient is preferred to the unfamiliar one, whereas effects of positive vs. negative framing depended on the type......Health claim perception was investigated by a web-based instrument with a sample of 4612 respondents in the Nordic countries (Denmark, Finland, Iceland, Norway, Sweden). Respondents decided which of a pair of claims sounded better, was easier to understand, and was more convincing in their opinion...

Health claims made on multivitamin and mineral supplements

Directory of Open Access Journals (Sweden)

Jelena Jovičić

2011-12-01

Full Text Available Introduction: Basic purpose of health claims is consumers' benefit by providing information about healthy eating habits. It is necessary for health claims to be scientifically substantiated and truthful. Health claims should not attribute to food the property of preventing, treating or curing a human disease. Use of health claims should be followed by a statement indicating the importance of a varied and balanced diet and a healthy lifestyle. The objective of this research was to examine the compliance of health claims made on multivitamin and mineral dietary supplements' labels on the Serbian market with national regulation concerning health safety of dietary products.Methods: An assessment of labels of MVMs was done in two privately owned pharmacies in Novi Sad, Serbia in August 2010.Results: In total, 48 MVMs were sampled and 22 health claims were detected. Seven out of 22 health claims were in compliance with the national regulation. The main reason for health claims on foreign MVMs not to be compliant with the regulation in Serbia was inadequate or nonexistent translation of original labels.Conclusion: Detected use of terms such as "prevention", "treatment" and "indications" on vitamin and mineral dietary supplements' labels is both forbidden and misleading to consumers. Coupled with inadequate or nonexistent translation of the labels, it leads to a low level of protection of Serbian consumers. It is necessary to establish an effective monitoring system for dietary supplements' labeling on a national scale in order toprotect consumers and their wellbeing.

The role of health-related claims and symbols in consumer behaviour

NARCIS (Netherlands)

Hieke, Sophie; Cascanette, Tamara; Pravst, Igor; Kaur, Asha; Trijp, Van Hans; Verbeke, Wim; Grunert, Klaus G.

2016-01-01

Health claims and symbols are a convenient tool when it comes to the marketing of foods and they should, in theory, support consumers in making informed food choices, ideally in choosing healthier food products. However, not much is known about their actual impact on consumer behaviour. CLYMBOL

A logistic regression model for Ghana National Health Insurance claims

Directory of Open Access Journals (Sweden)

Samuel Antwi

2013-07-01

Full Text Available In August 2003, the Ghanaian Government made history by implementing the first National Health Insurance System (NHIS in Sub-Saharan Africa. Within three years, over half of the country’s population had voluntarily enrolled into the National Health Insurance Scheme. This study had three objectives: 1 To estimate the risk factors that influences the Ghana national health insurance claims. 2 To estimate the magnitude of each of the risk factors in relation to the Ghana national health insurance claims. In this work, data was collected from the policyholders of the Ghana National Health Insurance Scheme with the help of the National Health Insurance database and the patients’ attendance register of the Koforidua Regional Hospital, from 1st January to 31st December 2011. Quantitative analysis was done using the generalized linear regression (GLR models. The results indicate that risk factors such as sex, age, marital status, distance and length of stay at the hospital were important predictors of health insurance claims. However, it was found that the risk factors; health status, billed charges and income level are not good predictors of national health insurance claim. The outcome of the study shows that sex, age, marital status, distance and length of stay at the hospital are statistically significant in the determination of the Ghana National health insurance premiums since they considerably influence claims. We recommended, among other things that, the National Health Insurance Authority should facilitate the institutionalization of the collection of appropriate data on a continuous basis to help in the determination of future premiums.

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

Science.gov (United States)

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.

Country Differences in the History of Use of Health Claims and Symbols

NARCIS (Netherlands)

Hieke, Sophie; Kuljanic, Nera; Fernandez, Laura; Lähteenmäki, Liisa; Stancu, Violeta; Raats, Monique; Egan, Bernadette; Brown, Kerry; Trijp, van Hans; Kleef, van Ellen; Herpen, van Erica; Gröppel-Klein, Andrea; Leick, Stephanie; Pfeifer, Katja; Verbeke, Wim; Hoefkens, Christine; Smed, Sinne; Jansen, Léon; Laser-Reuterswärd, Anita; Korošec, Živa; Pravst, Igor; Kušar, Anita; Klopčič, Marija; Pohar, Jure; Gracia, Azucena; Magistris, Tiziana; Grunert, Klaus

2016-01-01

Health-related claims and symbols are intended as aids to help consumers make informed and healthier food choices but they can also stimulate the food industry to develop food that goes hand in hand with a healthier lifestyle. In order to better understand the role that health claims and symbols

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health

DEFF Research Database (Denmark)

Tetens, Inge

The Panel on Dietetic Products, Nutrition and Allergies (NDA) has been asked by the European Food Safety Authority (EFSA) to draft guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. This guidance has been drawn from scientific opinions...

General scientific guidance for stakeholders on health claim applications

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5, 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need...... based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed.......The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation...

Use of health care claims data to study patients with ophthalmologic conditions.

Science.gov (United States)

Stein, Joshua D; Lum, Flora; Lee, Paul P; Rich, William L; Coleman, Anne L

2014-05-01

To describe what information is or is not included in health care claims data, provide an overview of the main advantages and limitations of performing analyses using health care claims data, and offer general guidance on how to report and interpret findings of ophthalmology-related claims data analyses. Systematic review. Not applicable. A literature review and synthesis of methods for claims-based data analyses. Not applicable. Some advantages of using claims data for analyses include large, diverse sample sizes, longitudinal follow-up, lack of selection bias, and potential for complex, multivariable modeling. The disadvantages include (a) the inherent limitations of claims data, such as incomplete, inaccurate, or missing data, or the lack of specific billing codes for some conditions; and (b) the inability, in some circumstances, to adequately evaluate the appropriateness of care. In general, reports of claims data analyses should include clear descriptions of the following methodological elements: the data source, the inclusion and exclusion criteria, the specific billing codes used, and the potential confounding factors incorporated in the multivariable models. The use of claims data for research is expected to increase with the enhanced availability of data from Medicare and other sources. The use of claims data to evaluate resource use and efficiency and to determine the basis for supplementary payment methods for physicians is anticipated. Thus, it will be increasingly important for eye care providers to use accurate and descriptive codes for billing. Adherence to general guidance on the reporting of claims data analyses, as outlined in this article, is important to enhance the credibility and applicability of findings. Guidance on optimal ways to conduct and report ophthalmology-related investigations using claims data will likely continue to evolve as health services researchers refine the metrics to analyze large administrative data sets. Copyright �

Health claims on foods: challenge for clinical research companies

Directory of Open Access Journals (Sweden)

Essi Sarkkinen

2012-06-01

Full Text Available Background The Nutrition and Health Claim Regulation 1924/2006/EC, together with EFSA guidances on the scientific requirements for different type of health claims, is setting the basis for health claim substantiation in the EU. Aim The aim of this presentation is to bring up the key challenges that the food industry and clinical research organizations are facing when meeting these requirements. Results and discussion Key issues in clinical research planning to meet the requirements set for the health claim substantiation are: (1 Selection of right outcome markers since the selection of outcome marker defines actually the formulation of the health claim to be used on food or food ingredient. (2 Selection of right target population since that determines the target consumer group for the food with a health claim. (3 Selection of dose regime and food matrices used since these largely determine the conditions set for the use of the health claim. One of the major challenges in health claim substantiation is the deviant approach to risk factors or biomarkers. From the regulation point of view, a single risk factor approach is emphasized, but from the clinical and scientific point of view the pattern of different risk markers or biomarkers could, in some cases, be a more relevant choice to reflect the final health outcome. This is especially the case in the nutrition and health area because we are often dealing with weak but multiple health effects of certain food items or ingredients. Also the lack of validated well-established biomarkers potent to be affected by diet is a challenge in health claim substantiation.The selection of right target population is often a compromise between choosing a more potential target group to obtain efficacy (i.e. risk factors elevated vs. patient groups and choosing a rationale to generalize the results to wider population (target consumer group.The selection of optimal dosing regime and matrices for a clinical study is

General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims

DEFF Research Database (Denmark)

Tetens, Inge

2011-01-01

to nutrition and health claims, and establishes rules governing the Community authorisation of health claims made on foods. This general guidance is a combined and updated version of two previous briefing documents (frequently asked question document related to the assessment of Article 14 and 13.5 health...... of available scientific evidence, pertinent studies for substantiation of health claims, wording of claims, the extent to which a food needs to be characterised for the claimed effect, claimed effects which are beneficial physiological effects, definition of a risk factor for the development of a human disease...

Health and nutrition content claims on Australian fast-food websites.

Science.gov (United States)

Wellard, Lyndal; Koukoumas, Alexandra; Watson, Wendy L; Hughes, Clare

2017-03-01

To determine the extent that Australian fast-food websites contain nutrition content and health claims, and whether these claims are compliant with the new provisions of the Australia New Zealand Food Standards Code ('the Code'). Systematic content analysis of all web pages to identify nutrition content and health claims. Nutrition information panels were used to determine whether products with claims met Nutrient Profiling Scoring Criteria (NPSC) and qualifying criteria, and to compare them with the Code to determine compliance. Australian websites of forty-four fast-food chains including meals, bakery, ice cream, beverage and salad chains. Any products marketed on the websites using health or nutrition content claims. Of the forty-four fast-food websites, twenty (45 %) had at least one claim. A total of 2094 claims were identified on 371 products, including 1515 nutrition content (72 %) and 579 health claims (28 %). Five fast-food products with health (5 %) and 157 products with nutrition content claims (43 %) did not meet the requirements of the Code to allow them to carry such claims. New provisions in the Code came into effect in January 2016 after a 3-year transition. Food regulatory agencies should review fast-food websites to ensure compliance with the qualifying criteria for nutrition content and health claim regulations. This would prevent consumers from viewing unhealthy foods as healthier choices. Healthy choices could be facilitated by applying NPSC to nutrition content claims. Fast-food chains should be educated on the requirements of the Code regarding claims.

Nutrition labelling, marketing techniques, nutrition claims and health claims on chip and biscuit packages from sixteen countries.

Science.gov (United States)

Mayhew, Alexandra J; Lock, Karen; Kelishadi, Roya; Swaminathan, Sumathi; Marcilio, Claudia S; Iqbal, Romaina; Dehghan, Mahshid; Yusuf, Salim; Chow, Clara K

2016-04-01

Food packages were objectively assessed to explore differences in nutrition labelling, selected promotional marketing techniques and health and nutrition claims between countries, in comparison to national regulations. Cross-sectional. Chip and sweet biscuit packages were collected from sixteen countries at different levels of economic development in the EPOCH (Environmental Profile of a Community's Health) study between 2008 and 2010. Seven hundred and thirty-seven food packages were systematically evaluated for nutrition labelling, selected promotional marketing techniques relevant to nutrition and health, and health and nutrition claims. We compared pack labelling in countries with labelling regulations, with voluntary regulations and no regulations. Overall 86 % of the packages had nutrition labels, 30 % had health or nutrition claims and 87 % displayed selected marketing techniques. On average, each package displayed two marketing techniques and one health or nutrition claim. In countries with mandatory nutrition labelling a greater proportion of packages displayed nutrition labels, had more of the seven required nutrients present, more total nutrients listed and higher readability compared with those with voluntary or no regulations. Countries with no health or nutrition claim regulations had fewer claims per package compared with countries with regulations. Nutrition label regulations were associated with increased prevalence and quality of nutrition labels. Health and nutrition claim regulations were unexpectedly associated with increased use of claims, suggesting that current regulations may not have the desired effect of protecting consumers. Of concern, lack of regulation was associated with increased promotional marketing techniques directed at children and misleadingly promoting broad concepts of health.

Health plan auditing: 100-percent-of-claims vs. random-sample audits.

Science.gov (United States)

Sillup, George P; Klimberg, Ronald K

2011-01-01

The objective of this study was to examine the relative efficacy of two different methodologies for auditing self-funded medical claim expenses: 100-percent-of-claims auditing versus random-sampling auditing. Multiple data sets of claim errors or 'exceptions' from two Fortune-100 corporations were analysed and compared to 100 simulated audits of 300- and 400-claim random samples. Random-sample simulations failed to identify a significant number and amount of the errors that ranged from $200,000 to $750,000. These results suggest that health plan expenses of corporations could be significantly reduced if they audited 100% of claims and embraced a zero-defect approach.

Development of a claim review and payment model utilizing diagnosis related groups under the Korean health insurance.

Science.gov (United States)

Shin, Y S; Yeom, Y K; Hwang, H

1993-02-01

This paper describes the development of a claim review and payment model utilizing the diagnosis related groups (DRGs) for the fee for service-based payment system of the Korean health insurance. The present review process, which examines all claims manually on a case-by-case basis, has been considered to be inefficient, costly, and time-consuming. Differences in case mix among hospitals are controlled in the proposed model using the Korean DRGs. They were developed by modifying the US-DRG system. An empirical test of the model indicated that it can enhance the efficiency as well as the credibility and objectivity of the claim review. Furthermore, it is expected that it can contribute effectively to medical cost containments and to optimal practice pattern of hospitals by establishing a useful mechanism in monitoring the performance of hospitals. However, the performance of this model needs to be upgraded by refining the Korean DRGs which play a key role in the model.

German Consumers’ Attitude towards Selenium-Biofortified Apples and Acceptance of Related Nutrition and Health Claims

Directory of Open Access Journals (Sweden)

Lena Wortmann

2018-02-01

Full Text Available The present study investigates consumers’ acceptance of Se-biofortified apples, as well as Se health and nutrition claims that have been approved by the European Commission. Despite indications that such statements are more likely to be accepted if the carrier product itself has a healthy image, unprocessed fruits biofortified with Se have not been investigated in this context yet. Apples as the most frequently-consumed type of fresh fruit in Germany may offer the potential to improve the Se status of consumers when the produce is enriched with Se. Therefore, an online survey of 356 German adults was conducted to analyze different aspects that could affect the perception of and preference for the proposed product concept by consumers. The findings indicate a moderate acceptance of Se-biofortified apples, as well as of Se health and nutrition claims among the participants. Additional information about beneficial health effects of Se had a significant impact on consumer acceptance. People who regularly eat convenience food and prefer to buy apples at supermarkets were particularly attracted by the product idea. In conclusion, the results of the study indicate good prospects for a successful introduction of Se-rich apples in the German food market, if the produce is advertised with approved health and nutrition claims.

Motivation outweighs ability in explaining European consumers’ use of health claims

DEFF Research Database (Denmark)

Hung, Yung; Grunert, Klaus G.; Hoefkens, Christine

2017-01-01

Health claims promise health benefits beyond basic nutrition, but their impact on food choices is largely determined by consumers’ motivation and ability to process these claims. This study investigates the role of consumers’ motivation and ability to process health claims as well as attitudinal...... that did not, despite the considerable differences in their historical and current prevalence of health claims. Therefore, European food and nutrition policies and marketing strategies should focus on ways to improve consumers’ motivation to process health claims by increasing their interest in healthy......, France, Denmark, Greece, and Lithuania (n = 5337). Structural equation modelling was used to simultaneously estimate the strength and direction of effects between motivation and ability to process, various determinants, and two components of health claim use. Motivation to process emerged as a key...

How to use health and nutrition-related claims correctly on food advertising: comparison of benefit-seeking, risk-avoidance, and taste appeals on different food categories.

Science.gov (United States)

Choi, Hojoon; Springston, Jeffrey K

2014-09-01

This study applies the concepts of health halos and unhealthy = tasty intuition to examine how the different health and nutrition-related (HNR) appeal types interact with different food product types compared with taste claims. The experiment investigated the impact of benefit-seeking and risk-avoidance HNR appeals compared with that of taste appeals on different food types. The authors found that although respondents evaluated food ads with the two HNR appeals as less risky/more beneficial and healthier than food ads with a taste claim, the respondents showed better ad-related evaluations on the HNR appeals for perceivably healthy food and on taste appeal for perceivably unhealthy food. The findings provide several theoretical and practical implications for health food marketing and public health policy.

The role of involvement in the choice of foods with nutrition and health claims

DEFF Research Database (Denmark)

Aschemann-Witzel, Jessica

Claims are gaining in importance as a tool of communication in the growing sector of health-related foods. In order to target the right consumers, it is crucial to determine their key characteristics. A realistically designed choice experiment aims at analysing the role of various determinants...... of choice for foods with claims. Logistic regression reveals that while product-involvement plays only a minor role, health-related food-involvement appears to be a better explanatory factor than e.g. sociodemographic variables. It is concluded that items measuring the latter type of involvement might...... be helpful for practical market research in the area of health-related foods....

Health claims as communication tools that enhance brand loyalty

DEFF Research Database (Denmark)

Krystallis, Athanasios; Chrysochou, Polymeros

2011-01-01

During the last decade a strong consumer interest has emerged for food products with health protecting or enhancing properties. In this connection, health claims are used as communication tools conveying the health message of a product and further constituting the means of a brand's differentiation...... on stated preference data using a purchase intention scale (i.e. Juster Scale), a set of Brand Performance Measures (BPMs) are empirically estimated to describe the market structure of two dairy product categories and their respective sub-categories that were defined according to health-related attributes...

Scientific Opinion on the substantiation of health claims related to glycaemic carbohydrates and maintenance of normal brain function pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following applications from Dextro Energy GmbH & Co. KG, submitted for the authorisation of health claims pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver...... an opinion on the scientific substantiation of health claims related to glycaemic carbohydrates and maintenance of normal brain function. The scope of the applications was proposed to fall under health claims based on newly developed scientific evidence. The Panel considers that the food constituent...

Health-related ad information and health motivation effects on product evaluations

DEFF Research Database (Denmark)

Chrysochou, Polymeros; Grunert, Klaus G

2014-01-01

This study tests the effect of health-related ad information on perceived product healthfulness and purchase intention. Also, the study investigates whether consumers' health motivation moderates the effects, because of the way health motivation affects processing of health-related information...... in ads. Three types of healthrelated ad elements are distinguished: functional claims, process claims and health imagery. These elements were combined in mock ads and an online experiment was run to test the study hypotheses. Results show that health imagery has the largest impact on consumers' product...

Danish Claims Data Indicators for Electronic Feedback in Oral-Health Care

DEFF Research Database (Denmark)

Rosing, Kasper; Christensen, Lisa Bøge; Listl, Stefan

, as one of several steps in constructing a model on how to promote preventive rather than restorative oral health care. Methods: Danish oral health claims data cover the range of dental care services under the National Health Insurance reimbursement scheme. Demographic and dental claims data on Danish...... adults (age range 18-106 years), who saw a dentist during 2014, n=2,703,442 corresponding to 61% of eligible adults, were obtained from the Danish Health Authority. Approval was granted from the Danish Data Protection Agency. Results: The following indicators of dental clinic service delivery profiles...... health professional, to compare “own” results with relevant groups of dental clinics locally, on a municipality, regional or national level. The indicators may be, to some degree, either individually or combined, considered suitable for comparison in between countries, because of their relatively simple...

32 CFR 536.118 - Related statutes for maritime claims.

Science.gov (United States)

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Related statutes for maritime claims. 536.118... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.118 Related statutes for maritime claims... under the AMCSA is not mandatory for causes of action as it is for the SIAA or PVA. (b) Similar maritime...

Opportunities, Problems and Pitfalls of Nutrition and Health Claims

NARCIS (Netherlands)

Bremmers, H.J.; Meulen, van der B.M.J.

2013-01-01

The provision of reliable food information, for instance by printing an authorised nutrition or health claim on a package of food, makes credence dimensions of a food transparent to the consumer. In Europe, prior-to-use authorisation of nutrition and health claims are mandatory and governed by

Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis.

Science.gov (United States)

Napalkov, Pavel; Felici, Diana M; Chu, Laura K; Jacobs, Joan R; Begelman, Susan M

2013-10-16

Central venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter-related complications in a large patient population in a United States-based health care claims database after CVC or HD catheter placement. Patients in the i3 InVision DataMart® health care claims database with at least 1 CVC or HD catheter insertion claim were categorized into CVC or HD cohorts using diagnostic and procedural codes from the US Renal Data System, American College of Surgeons, and American Medical Association's Physician Performance Measures. Catheter-related complications were identified using published diagnostic and procedural codes. Incidence rates (IRs)/1000 catheter-days were calculated for complications including catheter-related bloodstream infections (CRBSIs), thrombosis, embolism, intracranial hemorrhage (ICH), major bleeding (MB), and mechanical catheter-related complications (MCRCs). Thirty percent of the CVC cohort and 54% of the HD cohort had catheter placements lasting <90 days. Catheter-related complications occurred most often during the first 90 days of catheter placement. IRs were highest for CRBSIs in both cohorts (4.0 [95% CI, 3.7-4.3] and 5.1 [95% CI, 4.7-5.6], respectively). Other IRs in CVC and HD cohorts, respectively, were thrombosis, 1.3 and 0.8; MCRCs, 0.6 and 0.7; embolism, 0.4 and 0.5; MB, 0.1 and 0.3; and ICH, 0.1 in both cohorts. Patients with cancer at baseline had significantly higher IRs for CRBSIs and thrombosis than non-cancer patients. CVC or HD catheter-related complications were most frequently seen in patients 16 years or younger. The risk of catheter-related complications is highest during the first 90 days of catheter placement in patients with CVCs and HD catheters and in younger patients (≤16 years of age) with HD catheters. Data provided in this study can be applied

What are health-related users tweeting? A qualitative content analysis of health-related users and their messages on twitter.

Science.gov (United States)

Lee, Joy L; DeCamp, Matthew; Dredze, Mark; Chisolm, Margaret S; Berger, Zackary D

2014-10-15

Twitter is home to many health professionals who send messages about a variety of health-related topics. Amid concerns about physicians posting inappropriate content online, more in-depth knowledge about these messages is needed to understand health professionals' behavior on Twitter. Our goal was to characterize the content of Twitter messages, specifically focusing on health professionals and their tweets relating to health. We performed an in-depth content analysis of 700 tweets. Qualitative content analysis was conducted on tweets by health users on Twitter. The primary objective was to describe the general type of content (ie, health-related versus non-health related) on Twitter authored by health professionals and further to describe health-related tweets on the basis of the type of statement made. Specific attention was given to whether a tweet was personal (as opposed to professional) or made a claim that users would expect to be supported by some level of medical evidence (ie, a "testable" claim). A secondary objective was to compare content types among different users, including patients, physicians, nurses, health care organizations, and others. Health-related users are posting a wide range of content on Twitter. Among health-related tweets, 53.2% (184/346) contained a testable claim. Of health-related tweets by providers, 17.6% (61/346) were personal in nature; 61% (59/96) made testable statements. While organizations and businesses use Twitter to promote their services and products, patient advocates are using this tool to share their personal experiences with health. Twitter users in health-related fields tweet about both testable claims and personal experiences. Future work should assess the relationship between testable tweets and the actual level of evidence supporting them, including how Twitter users-especially patients-interpret the content of tweets posted by health providers.

Employee health and frequency of workers' compensation and disability claims.

Science.gov (United States)

Kuhnen, Ann E; Burch, Steven P; Shenolikar, Rahul A; Joy, Karen A

2009-09-01

To assess the relationship between self-assessed employee health risk status and future workers' compensation (WC) and short-term disability (STD) claims. A historical cohort study linking Health Risk Assessment (HRA) survey data with subsequent WC and STD claims. HRA participants who developed a WC or STD claim in the subsequent 12 months were identified as cases and compared with HRA participants who did not develop a claim in the subsequent 12 months. High-risk participants had higher odds of filing a WC claim, when compared with low-risk participants (OR: 2.99, 95% CI: 1.22 to 7.32) despite adjustment for demographic factors including job type. Medium-risk participants had 1.5 times higher odds, when compared with low-risk participants to file for STD (OR: 1.45, 95% CI: 1.15 to 1.82). Other relationships trended similarly but did not reach statistical significance. Self-assessed personal health risk does impact future lost productivity in WC and STD claims even after adjustment for demographic, health factors, and job type (WC only). Employers wishing to reduce the impact of lost productivity should consider a worker's personal health risks as predictors of future lost productivity and may want to address this in broad risk reduction programs.

Communicating healthier food choice : food composition data, front-of-pack nutrition labelling and health claims.

OpenAIRE

Hodgkins, Charo E.

2016-01-01

Background: Food composition data, front-of-pack nutrition labelling and nutrition and health claims have an important role to play in the development of appropriate policy, regulation and public health interventions ultimately aimed at reducing the burden of diet-related chronic disease. The overarching aim of this thesis is to explore whether the communication of healthier food choice through front-of-pack (FOP) nutrition labelling and health claims can be enhanced by the development of con...

Altering health-pleasure trade-off via advertising claims

NARCIS (Netherlands)

Bialkova, Svetlana; Bialkova, S.E.; Sasse, L.; Fenko, Anna; Verlegh, P.; Voorveld, H.; de Pelsmacker, P.

2014-01-01

The study investigated whether and how advertising claims (taste vs. health benefit) influenced consumer taste perception and buying intentions of potato chips. Participants (N=154) were exposed to the front of the product package and were invited to taste the product. Taste benefit claims lead to

The impact of health claims and food deprivation levels on health risk perceptions of fast-food restaurants.

Science.gov (United States)

Cadario, Romain

2016-01-01

We examined the effect of health claims and food deprivation levels on the health risk perceptions of fast-food restaurants. Consistent with previous research, we used a within-subjects experimental design to manipulate the health claims of fast-food restaurants using real brands: Subway, expressing strong health claims vs. McDonald's, expressing weak health claims. Participants who did not have access to nutrition information were asked to estimate the health risk associated with food items that were slightly more caloric for Subway than McDonald's (640 kcal vs. 600 kcal). We collected data through a web survey with a sample consisting of 414 American adults. Based on the USDA Food Insufficiency Indicator, participants were classified into two categorical food deprivation levels: food sufficiency and food insufficiency. We find that risk perceptions for obesity, diabetes and cardiac illnesses are lower (higher) for the restaurant with stronger (lower) health claims, i.e., Subway (McDonald's). Moreover, we also find that food deprivation levels moderate this effect, such that health risk underestimation is aggravated for individuals who suffer from food insufficiency. More precisely, we find that food insufficient individuals are more responsive to health claims, such that they perceive less health risk than food sufficient individuals for the restaurant with stronger health claims (Subway). Exploring the underlying mechanism of the latter effect, we found that dietary involvement mediates the relationship between food deprivation levels and health risk perceptions for the restaurant with stronger health claims (Subway). These results provide an interdisciplinary contribution in consumer psychology and public health. Copyright © 2015 Elsevier Ltd. All rights reserved.

Nordic scepticism towards health claims

DEFF Research Database (Denmark)

Pedersen, Susanne; Grunert, Klaus G.

2008-01-01

Imagine that you are shopping in a supermarket and find a package of pork chops labelled "omega-3 added" or that the yogurt "contains phosphatidylserine, which can improve your memory"; would you buy these pork chops or this yogurt? Most Nordic consumers would choose products without health claims....

Consumer appeal of nutrition and health claims in three existing product concepts.

Science.gov (United States)

Verbeke, Wim; Scholderer, Joachim; Lähteenmäki, Liisa

2009-06-01

This paper reports on consumers' reactions towards calcium-enriched fruit juice, omega-3 enriched spread and fibre-enriched cereals, each with a nutrition claim, health claim and reduction of disease risk claim. Cross-sectional data were collected in April 2006 from a sample of 341 consumers in Belgium. Consumers' reactions to the carrier product, functional ingredient and claim combinations were assessed as perceived convincingness of the claim, credibility of the product, attractiveness of the product, and intention to buy the product, while accounting for differences in product familiarity, attitudinal and demographic characteristics. Generally, health claims outperformed nutrition claims, and both of these claim types outperformed reduction of disease risk claims. Comparing consumer reactions across product concepts revealed clear preferences for fibre-enriched cereals as compared to the other two concepts. The interaction effects between claim type and product concept indicated that reduction of disease risk claims are perceived very well in omega-3 enriched spreads, particularly in terms of perceived convincingness of the claim, while not appealing to consumers in the other product concepts. Positive attitudes towards functional foods and familiarity with the concrete functional product category boosted the claim type and product ratings, whereas perceived control over own health and perceiving functional foods as a marketing scam decreased all product concept's appeal.

Association Between Employee Dental Claims, Health Risks, Workplace Productivity, and Preventive Services Compliance.

Science.gov (United States)

Burton, Wayne N; Chen, Chin-Yu; Li, Xingquan; Schultz, Alyssa B

2017-08-01

This study examined differences in health risks and workplace outcomes among employees who utilized preventive dental services compared with other employees. A retrospective observational study of employees of a large financial services corporation, with data from health risk appraisal questionnaires, medical claims, pharmacy claims, and dental claims. Employees with no dental claims were significantly more likely to have a variety of health risk factors (such as obesity and tobacco use), health conditions (such as diabetes), absenteeism, and lost on-the-job productivity, and were significantly less likely to be compliant with clinical preventive services compared with those with preventive dental claims. Employees with preventive dental claims had fewer health risks and medical conditions and better health and productivity measures. Study employees underutilized free dental care; employers should incorporate preventive dental care awareness into their worksite wellness programs.

When is an image a health claim? A false-recollection method to detect implicit inferences about products' health benefits.

Science.gov (United States)

Klepacz, Naomi A; Nash, Robert A; Egan, M Bernadette; Hodgkins, Charo E; Raats, Monique M

2016-08-01

Images on food and dietary supplement packaging might lead people to infer (appropriately or inappropriately) certain health benefits of those products. Research on this issue largely involves direct questions, which could (a) elicit inferences that would not be made unprompted, and (b) fail to capture inferences made implicitly. Using a novel memory-based method, in the present research, we explored whether packaging imagery elicits health inferences without prompting, and the extent to which these inferences are made implicitly. In 3 experiments, participants saw fictional product packages accompanied by written claims. Some packages contained an image that implied a health-related function (e.g., a brain), and some contained no image. Participants studied these packages and claims, and subsequently their memory for seen and unseen claims were tested. When a health image was featured on a package, participants often subsequently recognized health claims that-despite being implied by the image-were not truly presented. In Experiment 2, these recognition errors persisted despite an explicit warning against treating the images as informative. In Experiment 3, these findings were replicated in a large consumer sample from 5 European countries, and with a cued-recall test. These findings confirm that images can act as health claims, by leading people to infer health benefits without prompting. These inferences appear often to be implicit, and could therefore be highly pervasive. The data underscore the importance of regulating imagery on product packaging; memory-based methods represent innovative ways to measure how leading (or misleading) specific images can be. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

An evaluation of the International Monetary Fund's claims about public health.

Science.gov (United States)

Stuckler, David; Basu, Sanjay; Gilmore, Anna; Batniji, Rajaie; Ooms, Gorik; Marphatia, Akanksha A; Hammonds, Rachel; McKee, Martin

2010-01-01

The International Monetary Fund's recent claims concerning its impact on public health are evaluated against available data. First, the IMF claims that health spending either does not change or increases with IMF-supported programs, but there is substantial evidence to the contrary. Second, the IMF claims to have relaxed strict spending requirements in response to the 2008-9 financial crisis, but there is no evidence supporting this claim, and some limited evidence from the Center for Economic Policy Research contradicting it. Third, the IMF states that wage ceilings on public health are no longer part of its explicit conditionalities to poor countries, as governments can choose how to achieve public spending targets; but in practice, ministers are left with few viable alternatives than to reduce health budgets to achieve specific IMF-mandated targets, so the result effectively preserves former policy. Fourth, the IMF's claim that it has increased aid to poor countries also seems to be contradicted by its policies of diverting aid to reserves, as well as evidence that a very small fraction of the Fund's new lending in response to the financial crisis has reached poor countries. Finally, the IMF's claim that it follows public health standards in tobacco control contrasts with its existing policies, which fail to follow the guidelines recommended by the World Bank and World Health Organization. The authors recommend that the IMF (1) become more transparent in its policies, practices, and data to allow improved independent evaluations of its impact on public health (including Health Impact Assessment) and (2) review considerable public health evidence indicating a negative association between its current policies and public health outcomes.

Consumer appeal of nutrition and health claims in three existing product concepts

DEFF Research Database (Denmark)

Verbeke, Wim; Scholderer, Joachim; Lähteenmäki, Liisa

2009-01-01

This paper reports on consumers' reactions towards calcium-enriched fruit juice, omega-3 enriched spread and fibre-enriched cereals, each with a nutrition claim, health claim and reduction of disease risk claim. Cross-sectional data were collected in April 2006 from a sample of 341 consumers...... in Belgium. Consumers' reactions to the carrier product, functional ingredient and claim combinations were assessed as perceived convincingness of the claim, credibility of the product, attractiveness of the product, and intention to buy the product, while accounting for differences in product familiarity......, attitudinal and demographic characteristics. Generally, health claims outperformed nutrition claims, and both of these claim types outperformed reduction of disease risk claims. Comparing consumer reactions across product concepts revealed clear preferences for fibre-enriched cereals as compared to the other...

Scientific Opinion on the substantiation of a health claim related to glycaemic carbohydrates and contribution to normal cognitive function pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

an opinion on the scientific substantiation of a health claim related to glycaemic carbohydrates and contribution to normal cognitive function. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that the food constituent....... Such amounts can be consumed as part of a balanced diet. The target population is the general population....

Legal action against health claims on foods and beverages marketed to youth.

Science.gov (United States)

Rutkow, Lainie; Vernick, Jon S; Edwards, Danielle M; Rodman, Sarah O; Barry, Colleen L

2015-03-01

The prevalence of obesity among US children raises numerous health concerns. One pathway to reduce childhood obesity is by decreasing energy intake through the ingestion of fewer calories. Yet, food and beverage manufacturers often promote energy-dense items for children via varied health claims. Deceptive health claims are prohibited, and may be addressed through litigation or governmental regulatory efforts. While the amount of legal action against these potentially deceptive claims has increased, no comprehensive assessment has been conducted. This article, which analyzes litigation and governmental regulatory activities, considers key factors that may influence decisions to take legal action against potentially deceptive health claims on foods and beverages, including scientific support, forum selection, selection of plaintiffs, and potential public health impact.

Prebiotics, Fermentable Dietary Fiber, and Health Claims.

Science.gov (United States)

Delcour, Jan A; Aman, Per; Courtin, Christophe M; Hamaker, Bruce R; Verbeke, Kristin

2016-01-01

Since the 1970s, the positive effects of dietary fiber on health have increasingly been recognized. The collective term "dietary fiber" groups structures that have different physiologic effects. Since 1995, some dietary fibers have been denoted as prebiotics, implying a beneficial physiologic effect related to increasing numbers or activity of the gastrointestinal microbiota. Given the complex composition of the microbiota, the demonstration of such beneficial effects is difficult. In contrast, an exploration of the metabolites of dietary fiber formed as a result of its fermentation in the colon offers better perspectives for providing mechanistic links between fiber intake and health benefits. Positive outcomes of such studies hold the promise that claims describing specific health benefits can be granted. This would help bridge the "fiber gap"-that is, the considerable difference between recommended and actual fiber intakes by the average consumer. © 2016 American Society for Nutrition.

Stress related workers' compensation claims: recommendations involving records release.

Science.gov (United States)

Martin, K J

1992-08-01

1. The cost of stress claims is predicted to cripple the workers' compensation system, where stress claims are burgeoning and the average payout is twice that of a typical injury. The major reason to release medical records in a stress claim is to determine the validity of the claim arising from the job. 2. Occupational health nurses are frequently asked by the courts to reveal personal client information and may not be protected by the "nurse-client relationship" or "privileged communication." Politically, very little interest has been shown in restricting disclosure of private information. 3. Both ANA and AAOHN have adopted strong positions about safeguarding privacy. Legally, the ultimate responsibility for wrongful acts committed by the nurse falls on the individual nurse. 4. The most important reason to guard confidential health information is the basic tenet of the nurse-client relationship in which personal matters are held in confidence. To break this trust is to jeopardize the ability to provide optimal client care, which is the essence of nursing.

32 CFR 536.35 - Unique issues related to environmental claims.

Science.gov (United States)

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Unique issues related to environmental claims... issues related to environmental claims. Claims for property damage, personal injury, or death arising in... reported by USARCS to the Environmental Law Division of the Army Litigation Center and the Environmental...

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

Science.gov (United States)

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.

21 CFR 101.74 - Health claims: sodium and hypertension.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Health claims: sodium and hypertension. 101.74... claims: sodium and hypertension. (a) Relationship between sodium and hypertension (high blood pressure). (1) Hypertension, or high blood pressure, generally means a systolic blood pressure of greater than...

Health claims in the labelling and marketing of food products:

Science.gov (United States)

Asp, Nils-Georg; Bryngelsson, Susanne

2007-01-01

Since 1990 certain health claims in the labelling and marketing of food products have been allowed in Sweden within the food sector's Code of Practice. The rules were developed in close dialogue with the authorities. The legal basis was a decision by the authorities not to apply the medicinal products’ legislation to “foods normally found on the dinner table” provided the rules defined in the Code were followed. The Code of Practice lists nine well-established diet–health relationships eligible for generic disease risk reduction claims in two steps and general rules regarding nutrient function claims. Since 2001, there has also been the possibility for using “product-specific physiological claims (PFP)”, subject to premarketing evaluation of the scientific dossier supporting the claim. The scientific documentation has been approved for 10 products with PFP, and another 15 products have been found to fulfil the Code's criteria for “low glycaemic index”. In the third edition of the Code, active since 2004, conditions in terms of nutritional composition were set, i.e. “nutrient profiles”, with a general reference to the Swedish National Food Administration's regulation on the use of a particular symbol, i.e. the keyhole symbol. Applying the Swedish Code of practice has provided experience useful in the implementation of the European Regulation on nutrition and health claims made on foods, effective from 2007.

Functional foods: health claim-food product compatibility and the impact of health claim framing on consumer evaluation

NARCIS (Netherlands)

Kleef, van E.; Trijp, van H.C.M.; Luning, P.A.

2005-01-01

Two studies are reported, which aim to strengthen the scientific underpinning of strategic decisions regarding functional food development, as to (1) which health benefits to claim, (2) with which product (category), and (3) in which communication format. The first exploratory study is a secondary

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to medium-chain triglycerides and reduction in body weight (ID 643, 677, 1614) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to medium-chain triglycerides and reduction in body weight. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...... stakeholders. The food constituent that is the subject of the health claims is medium-chain triglycerides. In the context of the references provided, the Panel assumes that the food constituent which is the subject of the health claims is medium-chain fatty acids, which should replace long-chain fatty acids...... in triglycerides in order to obtain the claimed effect. The Panel considers that the food constituent, medium-chain fatty acids, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effect. The claimed effect is “weight management”. The target population is assumed...

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

OpenAIRE

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

2017-01-01

Background 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. Methods 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 fr...

Good for your health? An analysis of the requirements for scientific substantiation in European health claims regulation

Directory of Open Access Journals (Sweden)

Oliver Todt

2016-05-01

Full Text Available Objective. To identify the various types of evidence, as well as their relative importance in European health claims regulation, in order to analyze the consequences for consumer protection of the requirements for scientific substantiation in this regulation. Materials and methods. Qualitative analysis of various documents relevant to the regulatory process, particularly as to the implications of the standards of proof for the functional food market, as well as consumer behavior. Results. European regulation defines a hierarchy of evidence that turns randomized controlled trials into a necessary and sufficient condition for health claim autho- rizations. Conclusions. Consumer protection can be interpreted in different manners. High standards of proof protect consumers from false information about the health outcomes of functional foods, while lower standards lead to more, albeit less accurate information about such outcomes being available to consumers.

Recommendations for successful substantiation of new health claims in the European Union

DEFF Research Database (Denmark)

Pravst, Igor; Kušar, Anita; Žmitek, Katja

2018-01-01

Background While functional foods offer promise for public health and innovation in the food industry, the efficiency of such foods should be assured to protect consumers from misleading claims. Globally, many countries regulate the communication of the health effects of such foods to final...... consumers. Scope and approach In the European Union (EU), the use of health claims was harmonized in 2006. All claims need to be scientifically assessed by the European Food Safety Authority (EFSA) and pre-approved. Implementing the regulation has involved a steep learning curve for stakeholders, resulting...... recommendations should be seen as a starting point for researchers in the area of nutrition and food technology, and for those dealing with functional foods, including the food industry. Keywords Functional foods; Health claims; Food labelling; Substantiation; Regulation; European Union...

Marketing nutrition & health-related benefits of food & beverage products: enforcement, litigation & liability issues.

Science.gov (United States)

Roller, Sarah; Pippins, Raqiyyah

2010-01-01

Over the past decade, the liability risks associated with food and beverage product marketing have increased significantly, particularly with respect to nutrition and health-related product benefit claims. FDA and FTC enforcement priorities appear to have contributed to the increasing liability trends that are associated with these nutrition and health-related claims. This article examines key enforcement and litigation developments involving conventional food and beverage product marketing claims during the first 18 months of President Obama's administration: Part I considers FDA enforcement priorities and recent warning letters; Part II considers FTC enforcement priorities, warning letters, and consent orders; and Part III considers the relationship between FDA and FTC enforcement priorities and recent false advertising cases brought by private parties challenging nutrition and health-related marketing claims for food and beverage products. The article makes recommendations concerning ways in which food and beverage companies can help minimize liability risks associated with health-related marketing claims. In addition, the article suggests that federal policy reforms may be required to counter the perverse chilling effects current food liability trends appear to be having on health-related marketing claims for food and beverage products, and proposes a number of specific reforms that would help encourage the responsible use of well-substantiated marketing claims that can help foster healthy dietary practices. In view of the obesity prevention and other diet-related public health priorities of the Obama administration, the article suggests that this is an opportune time to address the apparent chilling effects increasing food liability risks are having on nutrition and health-related marketing claims for healthy food and beverage products, and potential adverse consequences for public health.

An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

Directory of Open Access Journals (Sweden)

Chatterjee S

2012-12-01

Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.

21 CFR 101.72 - Health claims: calcium, vitamin D, and osteoporosis.

Science.gov (United States)

2010-04-01

... claim may make reference to physical activity. (4) The claim may include information on the number of.... Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of..., provided that: (A) The claim makes clear the importance of adequate calcium intake, or when appropriate...

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

Science.gov (United States)

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.

[Work-related diseases and health-related compensation claims, Northeastern Brazil, 2000].

Science.gov (United States)

Souza, Norma Suely Souto; Santana, Vilma Sousa; Albuquerque-Oliveira, Paulo Rogério; Barbosa-Branco, Anadergh

2008-08-01

To estimate the contribution of work-related diseases to sick leaves due to general and occupational health problems. Sociodemographic, occupational and health data from 29,658 records of temporary disability benefits, granted on account of health problems by the Instituto Nacional do Seguro Social (National Institute of Social Security) in the state of Bahia (Northeastern Brazil), were analyzed. All constant ICD-10 clinical diagnoses were taken into consideration, except for those referring to external causes and factors that influence contact with health services. The link between diagnosis and occupation was based on the ICD-10 code and whether the type of compensation was due to a "work-related accident/disease" or not. From all the benefits, 3.1% were granted due to work-related diseases: 70% were musculoskeletal system and connective tissue diseases, while 14.5% were related to the nervous system. In general, benefits granted at more than two times the expected frequency were as follows: tenosynovitis in the manufacturing sector (Proportion Ratio-PR=2.70), carpal tunnel syndrome in the financial intermediation sector (PR=2.43), and lumbar disc degeneration in the transportation, postal service and telecommunications sectors (PR=2.17). However, no causal connection could be established for these diseases, in these activity sectors, in a significant percentage of benefits. Results suggest the existence of possible occupational risk factors for diseases in these fields of activity, as well as the underreporting of the link between diseases and work, thus disguising the responsibility of companies and the perspective of prevention through work reorganization.

Prebiotics, Fermentable Dietary Fiber, and Health Claims12

Science.gov (United States)

Aman, Per; Courtin, Christophe M; Hamaker, Bruce R; Verbeke, Kristin

2016-01-01

Since the 1970s, the positive effects of dietary fiber on health have increasingly been recognized. The collective term “dietary fiber” groups structures that have different physiologic effects. Since 1995, some dietary fibers have been denoted as prebiotics, implying a beneficial physiologic effect related to increasing numbers or activity of the gastrointestinal microbiota. Given the complex composition of the microbiota, the demonstration of such beneficial effects is difficult. In contrast, an exploration of the metabolites of dietary fiber formed as a result of its fermentation in the colon offers better perspectives for providing mechanistic links between fiber intake and health benefits. Positive outcomes of such studies hold the promise that claims describing specific health benefits can be granted. This would help bridge the “fiber gap”—that is, the considerable difference between recommended and actual fiber intakes by the average consumer. PMID:26773010

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

Science.gov (United States)

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

77 FR 9842 - Health Claim; Phytosterols and Risk of Coronary Heart Disease

Science.gov (United States)

2012-02-21

... (formerly 2006P-0316)] Health Claim; Phytosterols and Risk of Coronary Heart Disease AGENCY: Food and Drug... concerning the use of the health claim for phytosterols and risk of coronary heart disease (CHD), in a manner... risk of coronary heart disease (CHD) for phytosterol-containing conventional food and dietary...

Mental health claims management and return to work: qualitative insights from Melbourne, Australia.

Science.gov (United States)

Brijnath, Bianca; Mazza, Danielle; Singh, Nabita; Kosny, Agnieszka; Ruseckaite, Rasa; Collie, Alex

2014-12-01

Mental health conditions (MHC) are an increasing reason for claiming injury compensation in Australia; however little is known about how these claims are managed by different gatekeepers to injury entitlements. This study, drawing on the views of four stakeholders-general practitioners (GPs), injured persons, employers and compensation agents, aims to describe current management of MHC claims and to identify the current barriers to return to work (RTW) for injured persons with a MHC claim and/or mental illness. Ninety-three in-depth interviews were undertaken with GPs, compensation agents, employers and injured persons. Data were collected in Melbourne, Australia. Thematic techniques were used to analyse data. MHC claims were complex to manage because of initial assessment and diagnostic difficulties related to the invisibility of the injury, conflicting medical opinions and the stigma associated with making a MHC claim. Mental illness also developed as a secondary issue in the recovery process. These factors made MHC difficult to manage and impeded timely RTW. It is necessary to undertake further research (e.g. guideline development) to improve current practice in order to enable those with MHC claims to make a timely RTW. Further education and training interventions (e.g. on diagnosis and management of MHC) are also needed to enable GPs, employers and compensation agents to better assess and manage MHC claims.

Operator-related aspects in endodontic malpractice claims in Finland.

Science.gov (United States)

Vehkalahti, Miira M; Swanljung, Outi

2017-04-01

We analyzed operator-related differences in endodontic malpractice claims in Finland. Data comprised the endodontic malpractice claims handled at the Patient Insurance Centre (PIC) in 2002-2006 and 2011-2013. Two dental advisors at the PIC scrutinized the original documents of the cases (n = 1271). The case-related information included patient's age and gender, type of tooth, presence of radiographs, and methods of instrumentation and apex location. As injuries, we recorded broken instrument, perforation, injuries due to root canal irrigants/medicaments, and miscellaneous injuries. We categorized the injuries according to the PIC decisions as avoidable, unavoidable, or no injury. Operator-related information included dentist's age, gender, specialization, and service sector. We assessed level of patient documentation as adequate, moderate, or poor. Chi-squared tests, t-tests, and logistic regression modelling served in statistical analyses. Patients' mean age was 44.7 (range 8-85) years, and 71% were women. The private sector constituted 54% of claim cases. Younger patients, female dentists, and general practitioners predominated in the public sector. We found no sector differences in patients' gender, dentists' age, or type of injured tooth. PIC advisors confirmed no injury in 24% of claim cases; the advisors considered 65% of injury cases (n = 970) as avoidable and 35% as unavoidable. We found no operator-related differences in these figures. Working methods differed by operator's age and gender. Adequate patient documentation predominated in the public sector and among female, younger, or specialized dentists. Operator-related factors had no impact on endodontic malpractice claims.

EuroFIR eBASIS: application for health claims submissions and evaluations

DEFF Research Database (Denmark)

Kiely, M.; Black, L.J.; Plumb, J.

2010-01-01

Background: The European Food Information Resource (EuroFIR) network has established the eBASIS (Bioactive Substances in Food Information System) online food composition and biological effects database for plant-derived bioactive compounds (phytochemicals). On the basis of submitted evidence......, the European Food Safety Authority (EFSA) expert panel on Dietetic Products, Nutrition and Allergies assesses whether claims made under articles 13.1, 13.5 or 14 of the Regulation (EC) 1924/2006, which governs the use of nutrition and health claims on foods, are scientifically justified. This report evaluates...... the eBASIS biological effects database in the preparation and evaluation of health claims dossiers. Methods: The eBASIS biological effects database is a compilation of expert-evaluated data extracted from the literature, prioritising human intervention studies to investigate health effects...

Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management.

Science.gov (United States)

Martini, Daniela; Biasini, Beatrice; Rossi, Stefano; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

2018-06-01

All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to OptiEFAX™ and maintenance of normal blood HDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

on the scientific substantiation of a health claim related to OptiEFAX™ and maintenance of normal blood HDL-cholesterol concentrations. The food that is the subject of the health claim, OptiEFAX™, which is standardised pure krill oil, is sufficiently characterised in relation to the claimed effect. The claimed...... effect, maintenance of normal blood HDL-cholesterol concentrations, is a beneficial physiological effect. The target population proposed by the applicant is the general population. No human studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim....... A cause and effect relationship has not been established between the consumption of OptiEFAX™ and maintenance of normal blood HDL-cholesterol concentrations....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to OptiEFAX™ and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

substantiation of a health claim related to OptiEFAX™ and maintenance of normal blood LDL-cholesterol concentrations. The food that is the subject of the health claim, OptiEFAX™, which is standardised pure krill oil, is sufficiently characterised in relation to the claimed effect. The claimed effect, maintenance...... of normal blood LDL-cholesterol concentrations, is a beneficial physiological effect. The target population proposed by the applicant is the general population. No human studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect...... relationship has not been established between the consumption of OptiEFAX™ and maintenance of normal blood LDL-cholesterol concentrations....

Online E-cigarette Marketing Claims: A Systematic Content and Legal Analysis.

Science.gov (United States)

Klein, Elizabeth G; Berman, Micah; Hemmerich, Natalie; Carlson, Cristen; Htut, SuSandi; Slater, Michael

2016-07-01

Electronic nicotine delivery systems (ENDS), or e-cigarettes, are heavily marketed online. The purpose of our study was to perform a systematic identification and evaluation of claims made within ENDS retailer and manufacturer websites, and the legal status of such claims. We employed a systematic search protocol with popular search engines using 6 terms: (1) e-cigarettes; (2) e-cigs; (3) e-juice; (4) e-liquid; (5) e-hookah; and (6) vape pen. We analyzed English-language websites where ENDS are sold for implicit and explicit health-related claims. A legal analysis determined whether such claims are permissible under the US Food and Drug Administration's regulations. The vast majority of ENDS manufacturer (N = 78) and retailer (N = 32) websites made at least one health-related claim (77% and 65%, respectively). Modified risk claims and secondhand smoke-related claims were most prevalent, with an average of 2 claims per site. Health-related claims are plentiful within ENDS manufacturer and retailer websites. Results demonstrate that these sites focus on potential benefits while minimizing or eliminating information about possible harmful effects of ENDS. These claims are subject to the current regulatory authority by the FDA, and pose a risk of misinforming consumers.

Food labeling: health claims; D-tagatose and dental caries. Final rule.

Science.gov (United States)

2003-07-03

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on sugar alcohols and dental caries, i.e., tooth decay, to include the sugar D-tagatose as a substance eligible for the dental caries health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.

European Health Claims for Small and Medium-Sized Companies – Utopian Dream or Future Reality?

Directory of Open Access Journals (Sweden)

Sonja Brandenburger

2015-02-01

Full Text Available Background: In December 2007, the European Regulation (EC 1924/2006 on nutrition and health claims came into force. The European Union wanted to regulate the use of health claims on products. An online survey was carried out to evaluate the situation, particularly of small and medium-sized companies, dealing with the new regulation. Methods: The online survey on health claims was conducted with 16 enterprises. To underline the findings a SWOT (Strength, Weaknesses, Opportunities, Threats analysis was made of the nutrition and health claims regulation regarding small and medium-sized companies in the European food and drink market. Results: The findings of this study indicated that the European Union did a step in the right direction. Most companies defined the decent competition, the simplified trade within the inner-European market, and the consumer protection as positive aspects. The biggest threat is seen in false investment conditioned by the limited research and development budgets, especially of small and medium-sized enterprises, and the cost intensive scientific evaluation to reach an authorized health claim. Conclusions: Overall, there are several strengths and opportunities speaking for SMEs and health claims in the near future. The most promising ones are the publishing of the new European Union Register of Nutrition and Health Claims and the learning effects that will occur. The biggest threat is, and will remain to be, false investment and the possible loss of a lot of money. Nevertheless, health claims for small and medium-sized enterprises will inevitably be the future to keep the European food and drink market competitive.

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

Science.gov (United States)

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.

Impact of health claims in prebiotic-enriched breads on purchase intent, emotional response and product liking.

Science.gov (United States)

Coleman, Katie L; Miah, Emma M; Morris, Gordon A; Morris, Cecile

2014-03-01

The impact of health claims on purchase intent, emotional response and liking has never been previously reported. In this study, prebiotic-enriched bread was used as a model functional food. Purchase intent, emotional response and liking were investigated in three phases: (1) focus groups were used to gauge consumer perception of health claims and functional foods, (2) the impact of health claims on purchase intent and emotional responses were measured using an online survey (n = 122) and (3) hedonic ratings on bread rolls presented with or without any associated claims were obtained (n = 100). A cluster analysis of the purchase intent data identified two clusters of consumers who were either receptive or non-receptive to health claims. Receptive and non-receptive consumers significantly differed in the emotions they reported with respect to the claims. The hedonic ratings did not significantly differ between the breads tasted with or without health claims.

This Article Makes You Smarter! (Or, Regulating Health and Wellness Claims).

Science.gov (United States)

Duranske, Sarah

2017-03-01

Information has power - to inspire, to transform, and to harm. Recent technological advancements have enabled the creation of products that offer consumers direct access to a level of personal health information unprecedented in history. But how are we to balance the promise of health and wellness information with its risks? Two agencies are tasked with protecting consumers from false claims of health products: the FDA and the FTC. This Article investigates if they are up to the task. In part a study of agency policymaking choices, and in part a prescription for more thoughtful and focused regulation, this Article compares both intra-agency and inter-agency regulation of informational health and wellness products. Certain procedural and substantive characteristics of FDA regulation are unsuited to informational health and wellness products, rendering comprehensive regulation by the FDA unrealistic. This gap creates an opportunity for the FTC to use its distinct and well-tailored enforcement tools to police harmful product claims that escape the FDA's purview. I posit that by tailoring the FDA's responsibility and sustaining the FTC's engagement with health claims, the agencies can dovetail into a cohesive and comprehensive regulatory regime.

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

Directory of Open Access Journals (Sweden)

Zenobia Talati

2016-12-01

Full Text Available 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.

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

Science.gov (United States)

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 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.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to caffeine and theobromine in cocoa (Theobroma cacao L.) and enhancement of mood (ID 4276) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to caffeine and theobromine in cocoa (Theobroma cacao L.) and enhancement of mood. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States...... or directly from stakeholders. The food that is the subject of the health claim is cocoa (Theobroma cacao L.). The Panel considers that whereas the food, cocoa (Theobroma cacao L.), is not sufficiently characterised in relation to the claimed effect evaluated in this opinion, the food constituents, caffeine...

Leading Causes of Anesthesia-Related Liability Claims in Ambulatory Surgery Centers.

Science.gov (United States)

Ranum, Darrell; Beverly, Anair; Shapiro, Fred E; Urman, Richard D

2017-11-16

We present a contemporary analysis of patient injury, allegations, and contributing factors of anesthesia-related closed claims, which involved cases that specifically occurred in free-standing ambulatory surgery centers (ASCs). We examined ASC-closed claims data between 2007 and 2014 from The Doctors Company, a medical malpractice insurer. Findings were coded using the Comprehensive Risk Intelligence Tool developed by CRICO Strategies. We compared coded data from ASC claims with hospital operating room (HOR) claims, in terms of injury severity category, nature of injury, nature of allegation, contributing factors identified, and contributing comorbidities and claim value. Ambulatory surgery center claims were more likely to be classified as medium severity than HOR claims, more likely to involve dental damage or pain than HOR claims, but less likely to involve death or respiratory or cardiac arrest. Technical performance was the most common contributing factor: 47% of ASCs and 48% of HORs. Only 7% of allegations relating to technical performance were judged to be a direct result of poor technical performance. The most common anesthesia procedures resulting in ASC claims were injection of anesthesia into a peripheral nerve (34%) and intubation (29%). Obesity was the most common contributing comorbidity in both settings. Mean closed claim value was significantly lower for ASC than HOR claims, averaging US $87,888 versus $107,325. Analysis of ASC and HOR claims demonstrates significant differences and several common sources of liability. These include improving strategies for thorough screening, preoperative assessment and risk stratifying of patients, incorporating routine dental and airway assessment and documentation, diagnosing and treating perioperative pain adequately, and improving the efficacy of communication between patients and care providers.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to folate and maintenance of normal blood pressure (ID 176) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to folate and maintenance of normal blood pressure. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to xanthan gum and changes in bowel function (ID 837) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to xanthan gum and changes in bowel function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to spermidine and contribution to normal hair growth (ID 1705) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to spermidine and contribution to normal hair growth. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders...

EFSA Panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on the substantiation of health claims related to creatine and increased attention (ID 1524) and improvement of memory (ID 1528) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to creatine and increased attention and improvement of memory. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...... stakeholders. The food constituent that is the subject of the health claims is creatine. The Panel considers that creatine is sufficiently characterised....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to ribose and faster recovery from muscle fatigue after exercise (ID 4226) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to ribose and faster recovery from muscle fatigue after exercise. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...... stakeholders. The food that is the subject of the health claim is ribose. The Panel considers that ribose is sufficiently characterised. The claimed effect is “maintenance of ATP levels, exercise performance, exercise recovery”. The target population is assumed to be adults performing strenuous exercise...

Health and nutrition content claims on websites advertising infant formula available in Australia: A content analysis.

Science.gov (United States)

Berry, Nina J; Gribble, Karleen D

2017-10-01

The use of health and nutrition content claims in infant formula advertising is restricted by many governments in response to WHO policies and WHA resolutions. The purpose of this study was to determine whether such prohibited claims could be observed in Australian websites that advertise infant formula products. A comprehensive internet search was conducted to identify websites that advertise infant formula available for purchase in Australia. Content analysis was used to identify prohibited claims. The coding frame was closely aligned with the provisions of the Australian and New Zealand Food Standard Code, which prohibits these claims. The outcome measures were the presence of health claims, nutrition content claims, or references to the nutritional content of human milk. Web pages advertising 25 unique infant formula products available for purchase in Australia were identified. Every advertisement (100%) contained at least one health claim. Eighteen (72%) also contained at least one nutrition content claim. Three web pages (12%) advertising brands associated with infant formula products referenced the nutritional content of human milk. All of these claims appear in spite of national regulations prohibiting them indicating a failure of monitoring and/or enforcement. Where countries have enacted instruments to prohibit health and other claims in infant formula advertising, the marketing of infant formula must be actively monitored to be effective. © 2016 John Wiley & Sons Ltd.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to “non-digestible oligo- and polysaccharides including galactooligosaccharides, oligofructose, polyfructose and inulin” and “increase in calcium

DEFF Research Database (Denmark)

Tetens, Inge

to deliver an opinion on the scientific substantiation of a health claim related to “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin” and “increase in calcium absorption”. The scope of the application was proposed to fall under a health...... claim referring to children’s development and health. The food constituents that are proposed by the applicant to be the subject of the health claim are “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin”. Upon requests by EFSA...... for clarification on the food constituent, the applicant did not clarify the food constituent that is the subject of the health claim. The Panel considers that the food constituents, “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin”, which...

The EU health claims regulation: impact on the marine lipids

Directory of Open Access Journals (Sweden)

Kohler Carole

2010-07-01

Full Text Available European Regulation (EC No 1924/2006 applies to all types of pre-packed foods for the final consumer, including food intended to supply hospitals, canteens and similar mass caterers, bearing nutrition and health claims. Commercial communications (labelling, presentation or advertising of foods, trade names and other brand names which may be construed as nutrition or health claims are covered by the Regulation. Since the date it was brought into force (1st July 2007, all nutrition and health claims for food products must be authorised prior to the marketing of the products, either by means of a nominative evaluation procedure or a generic evaluation. In light of the provisions of the new Regulation and the transitional measures in effect, what is the future of lipid ‘health communication’ and more particularly of marine lipid communication? For certain lipids of marine origin (e.g., EPA, DHA, etc. play an unquestionable nutritional – not to say health – role in the human diet, a fact which is widely accepted by the scientific community.

The produsing expert consumer: Co-constructing, resisting and accepting health-related claims on social media in response to an infotainment show about food.

Science.gov (United States)

Declercq, Jana; Tulkens, Stéphan; Van Leuven, Sarah

2018-03-01

This article examines the Twitter and Facebook uptake of health messages from an infotainment TV show on food, as broadcasted on Belgium's Dutch-language public broadcaster. The interest in and amount of health-related media coverage is rising, and this media coverage is an important source of information for laypeople, and impacts their health behaviours and therapy compliance. However, the role of the audience has also changed; consumers of media content increasingly are produsers, and, in the case of health, expert consumers. To explore how current audiences react to health claims, we have conducted a quantitative and qualitative content analysis of Twitter and Facebook reactions to an infotainment show about food and nutrition. We examine (1) to which elements in the show the audience reacts, to gain insight in the traction the nutrition-related content generates and (2) whether audience members are accepting or resisting the health information in the show. Our findings show that the information on health and production elicit the most reactions, and that health information incites a lot of refutation, low acceptance and a lot of suggestions on new information or new angles to complement the show's information.

How Danes evaluate moral claims related to abortion

DEFF Research Database (Denmark)

Uldall, Sigurd Wiingaard

2015-01-01

OBJECTIVE: To investigate how Danish citizens evaluate four moral claims related to abortion issues, regarding the moral status of the fetus, autonomy, harm and possible negative consequences of allowing abortion and to explore the association between moral beliefs and attitudes towards abortion...... to at least one moral claim. Two hundred and fifty-eight responded to all four claims without using the option 'neither agree nor disagree' and were classified as 'morally engaged responders'. A majority of these had a pro-abortion moral. The general relationship between moral beliefs and attitudes towards...... abortion was morally sound. Being 'morally engaged' did not increase the likelihood of reaching moral judgement on whether requests for abortion should be permitted. Education, religion and parenthood were statistically associated with the investigated issues. DISCUSSION: The direction of causality...

Scientific Opinion on the substantiation of a health claim related to fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

substantiation of a health claim related to fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context...... of an energy-restricted diet. The food that is the subject of the claim is fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims. The Panel considers that fat-free yogurts......-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and reduction of body and visceral fat mass while maintaining lean body mass in the context of an energy-restricted diet....

Claim Assessment Profile: A Method for Capturing Healthcare Evidence in the Scientific Evaluation and Review of Claims in Health Care (SEaRCH).

Science.gov (United States)

Hilton, Lara; Jonas, Wayne B

2017-02-01

Grounding health claims in an evidence base is essential for determining safety and effectiveness. However, it is not appropriate to evaluate all healthcare claims with the same methods. "Gold standard" randomized controlled trials may skip over important qualitative and observational data about use, benefits, side effects, and preferences, issues especially salient in research on complementary and integrative health (CIH) practices. This gap has prompted a move toward studying treatments in their naturalistic settings. In the 1990s, a program initiated under the National Institutes of Health was designed to provide an outreach to CIH practices for assessing the feasibility of conducting retrospective or prospective evaluations. The Claim Assessment Profile further develops this approach, within the framework of Samueli Institute's Scientific Evaluation and Review of Claims in Health Care (SEaRCH) method. The goals of a Claim Assessment Profile are to clarify the elements that constitute a practice, define key outcomes, and create an explanatory model of these impacts. The main objective is to determine readiness and capacity of a practice to engage in evaluation of effectiveness. This approach is informed by a variety of rapid assessment and stakeholder-driven methods. Site visits, structured qualitative interviews, surveys, and observational data on implementation provide descriptive data about the practice. Logic modeling defines inputs, processes, and outcome variables; Path modeling defines an analytic map to explore. The Claim Assessment Profile is a rapid assessment of the evaluability of a healthcare practice. The method was developed for use on CIH practices but has also been applied in resilience research and may be applied beyond the healthcare sector. Findings are meant to provide sufficient data to improve decision-making for stakeholders. This method provides an important first step for moving existing promising yet untested practices into

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

Directory of Open Access Journals (Sweden)

Lena V Nordheim

Full Text Available 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

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

Science.gov (United States)

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

21 CFR 101.14 - Health claims: general requirements.

Science.gov (United States)

2010-04-01

... evidence (including evidence from well-designed studies conducted in a manner which is consistent with... sold in a restaurant or in other establishments in which food that is ready for immediate human... food for which a health claim is made in accordance with § 101.9; for restaurant foods, in accordance...

Consumer Health: Does Advertising Work on You? and Evaluating a Product's Health Claims.

Science.gov (United States)

Cox, Carolyn C.

This paper describes lessons for teaching middle and high school students how to determine if they are influenced by the power of advertising and how to evaluate a product's health claims. To determine the influence of advertising, teachers have high school students discuss what their latest health product/service purchase was, why they bought it,…

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sodium and maintenance of normal muscle function (ID 359) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to sodium and maintenance of normal muscle function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders...... with a greater likelihood of increased blood pressure, which in turn has been directly related to the development of cardiovascular and renal diseases. For these reasons, national and international bodies have set targets for a reduction in dietary sodium intakes....

How many foods in the UK carry health and nutrition claims, and are they healthier than those that do not?

Science.gov (United States)

Kaur, Asha; Scarborough, Peter; Matthews, Anne; Payne, Sarah; Mizdrak, Anja; Rayner, Mike

2016-04-01

The present study aimed to measure the prevalence of different types of health and nutrition claims on foods and non-alcoholic beverages in a UK sample and to assess the nutritional quality of such products carrying health or nutrition claims. A survey of health and nutrition claims on food packaging using a newly defined taxonomy of claims and internationally agreed definitions of claim types. A national UK food retailer: Tesco. Three hundred and eighty-two products randomly sampled from those available through the retailer's website. Of the products, 32 % (95 % CI 28, 37 %) carried either a health or nutrition claim; 15 % (95 % CI 11, 18 %) of products carried at least one health claim and 29 % (95 % CI 25, 34 %) carried at least one nutrition claim. When adjusted for product category, products carrying health claims tended to be lower in total fat and saturated fat than those that did not, but there was no significant difference in sugar or sodium levels. Products carrying health claims had slightly higher fibre levels than products without. Results were similar for comparisons between products that carry nutrition claims and those that do not. Health and nutrition claims appear frequently on food and beverage products in the UK. The nutrient profile of products carrying claims is marginally healthier than for similar products without claims, suggesting that claims may have some but limited informational value. The implication of these findings for guiding policy is unclear; future research should investigate the 'clinical relevance' of these differences in nutritional quality.

75 FR 43329 - Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Internal...

Science.gov (United States)

2010-07-23

... 45 CFR Part 147 Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to... Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and... of Labor; Office of Consumer Information and Insurance Oversight, Department of Health and Human...

45 CFR 149.320 - Universe of claims that must be submitted.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Universe of claims that must be submitted. 149.320 Section 149.320 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH... Universe of claims that must be submitted. (a) Claims submitted for an early retiree, as defined in § 149.2...

EFSA Panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on the substantiation of a health claim related to collagen hydrolysate and maintenance of joints pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Gelita AG, submitted via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to collagen hydrolysate and maintenance of joint health...... hydrolysate is sufficiently characterised. The claimed effect is “maintenance of joint health”. The target population as proposed by the applicant is physically active people. The Panel considers that the maintenance of joints is a beneficial physiological effect. The applicant provided one narrative review...... was not controlled and no scientific conclusions could be drawn from these studies for the substantiation of the claimed effect. One trial in 147 active student athletes evaluated a total of 15 parameters related to joint pain/discomfort. There were no significant differences between groups for any endpoint when...

Gender Disparities in Ghana National Health Insurance Claims: An Econometric Analysis

Directory of Open Access Journals (Sweden)

Samuel Antwi

2014-01-01

Full Text Available The objective of this study was to find out the gender disparities in Ghana national health insurance claims. In this work, data was collected from the policyholders of the Ghana National Health Insurance Scheme with the help of the National Health Insurance database and the patients’ attendance register of the Koforidua Regional Hospital, from 1st January to 31st December 2011. The generalized linear regression (GLR models and the SPSS version 17.0 were used for the analysis. Among men, the younger people prefer attending hospital for treatment as compared to their adult counterparts. In contrast to women, younger women favor attending hospital for treatment as compared to their adult counterparts. Among men, various levels of income impact greatly on their propensity to make an insurance claim, whereas among women only the highest income level did as compared to lowest income level.Men, who completed senior high school education, were less likely to make an insurance claim as compared to their counterparts with basic or no education. However it was women who had basic education that preferred using the hospital as compared to their more educated counterparts. It is suggested that the government should consider building more health centers, clinics and cheap-compounds in at least every community, to help reduce the travel time in accessing health care.  The ministry of health and the Ghana health service should engage older citizens by encouraging them to use hospitals when they are sick instead of other alternative care providers.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of Lactobacillus delbrueckii subsp. bulgaricus AY/CSL (LMG P-17224) and Streptococcus thermophilus 9Y/CSL (LMG P-17225) and “beneficial modulation

DEFF Research Database (Denmark)

Tetens, Inge

of a health claim related to a combination of Lactobacillus delbrueckii subsp. bulgaricus AY/CSL (LMG P-17224) and Streptococcus thermophilus 9Y/CSL (LMG P-17225) and “beneficial modulation of intestinal microflora”. The scope of the application was proposed to fall under a health claim referring to children......’s development and health. The food constituent that is the subject of the health claim, a combination of L. delbrueckii subsp. bulgaricus AY/CSL (LMG P-17224) and S. thermophilus 9Y/CSL (LMG P-17225), has not been sufficiently characterised. The claimed effect is “beneficial modulation of the intestinal...... that a cause and effect relationship has not been established between the consumption of the food constituent, the combination of L. delbrueckii subsp. bulgaricus AY/CSL (LMG P-17224) and S. thermophilus 9Y/CSL (LMG P-17225), and a beneficial physiological effect related to “beneficial modulation...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sodium bicarbonate and maintenance of normal blood pressure (ID 1404) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to sodium bicarbonate and maintenance of normal blood pressure. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...... stakeholders. The food constituent that is the subject of the health claim is sodium bicarbonate. The Panel considers that sodium bicarbonate is sufficiently characterised. The claimed effect is “blood pressure reduction”. The target population is assumed to be the general population. In the context...... substantiation of the claim. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of sodium bicarbonate and maintenance of normal blood pressure....

Food claims and nutrition facts of commercial infant foods.

Science.gov (United States)

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.

Medical insurance claims associated with international business travel.

Science.gov (United States)

Liese, B; Mundt, K A; Dell, L D; Nagy, L; Demure, B

1997-07-01

Preliminary investigations of whether 10,884 staff and consultants of the World Bank experience disease due to work related travel. Medical insurance claims filed by 4738 travellers during 1993 were compared with claims of non-travellers. Specific diagnoses obtained from claims were analysed overall (one or more v no missions) and by frequency of international mission (1, 2-3, or > or = 4). Standardised rate of claims ratios (SSRs) for each diagnostic category were obtained by dividing the age adjusted rate of claims for travellers by the age adjusted rate of claims for non-travellers, and were calculated for men and women travellers separately. Overall, rates of insurance claims were 80% higher for men and 18% higher for women travellers than their non-travelling counterparts. Several associations with frequency of travel were found. SRRs for infectious disease were 1.28, 1.54, and 1.97 among men who had completed one, two or three, and four or more missions, and 1.16, 1.28, and 1.61, respectively, among women. The greatest excess related to travel was found for psychological disorders. For men SRRs were 2.11, 3.13, and 3.06 and for women, SRRs were 1.47, 1.96, and 2.59. International business travel may pose health risks beyond exposure to infectious diseases. Because travellers file medical claims at a greater rate than non-travellers, and for many categories of disease, the rate of claims increases with frequency of travel. The reasons for higher rates of claims among travellers are not well understood. Additional research on psychosocial factors, health practices, time zones crossed, and temporal relation between travel and onset of disease is planned.

GlyEFSA NDA Panel (EFSA Panel on Dietetic Product s, Nutrition and Allergies), 20 13 . Scientific Opinion on the substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after stren uous exercise pursuant to Article 13(5) of Regulation

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Aptonia, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise. The food constituent, glycaemic carbohydrates, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. Recovery...... to the recovery of normal skeletal muscle function (contraction), the Panel concludes that a cause and effect relationship has been established between the consumption of glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to acetyl-L-carnitine and contribution to normal cognitive function (ID 1432) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to acetyl-L-carnitine and contribution to normal cognitive function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... be drawn for the scientific substantiation of the claim. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of acetyl-L-carnitine and contribution to normal cognitive function....

Consumer understanding of sugars claims on food and drink products

OpenAIRE

Patterson, N J; Sadler, M J; Cooper, J M

2012-01-01

Consumer understanding of nutrition and health claims is a key aspect of current regulations in the European Union (EU). In view of this, qualitative and quantitative research techniques were used to investigate consumer awareness and understanding of product claims in the UK, focusing particularly on nutrition claims relating to sugars. Both research methods identified a good awareness of product claims. No added sugars claims were generally preferred to reduced sugars claims, and there was ...

General health assessment in refugees claiming to have been tortured

DEFF Research Database (Denmark)

Draminsky Petersen, Hans; Christensen, Maria Elisabeth; Kastrup, Marianne

1994-01-01

General health assessment of refugees claiming to have been previously exposed to torture takes place in a psychological atmosphere affected by the difficult situation of the refugee. Thirty-one refugees, mainly from the Middle East and Africa, were assessed as regards their physical and mental...... (P general) health. Reliability was moderate with respect to clinical observation during interview....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to Lactobacillus rhamnosus ATCC 53103 (LGG) and “gastro-intestinal health” (ID 906) and maintenance of tooth mineralisation (ID 3018) pursuant to Article 13

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to Lactobacillus rhamnosus ATCC 53103 (LGG) and “gastrointestinal health” and maintenance of tooth mineralisation. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has...... received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is L. rhamnosus ATCC 53103 (LGG). The Panel considers that L. rhamnosus ATCC 53103 (LGG) is sufficiently characterised....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to chitosan and reduction in body weight (ID 679, 1499), maintenance of normal blood LDL-cholesterol concentrations (ID 4663), reduction of intestinal transit time (ID

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to chitosan and reduction in body weight, maintenance of normal blood LDL-cholesterol concentrations, reduction of intestinal transit time and reduction of inflammation. The scientific substantiation is based on the information provided by the Member States in the consolidated list...... of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is chitosan. The Panel considers that chitosan is sufficiently characterised....

21 CFR 101.78 - Health claims: fruits and vegetables and cancer.

Science.gov (United States)

2010-04-01

... smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Health claims: fruits and vegetables and cancer. 101.78 Section 101.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

Analysis of medication-related malpractice claims: causes, preventability, and costs.

Science.gov (United States)

Rothschild, Jeffrey M; Federico, Frank A; Gandhi, Tejal K; Kaushal, Rainu; Williams, Deborah H; Bates, David W

2002-11-25

Adverse drug events (ADEs) may lead to serious injury and may result in malpractice claims. While ADEs resulting in claims are not representative of all ADEs, such data provide a useful resource for studying ADEs. Therefore, we conducted a review of medication-related malpractice claims to study their frequency, nature, and costs and to assess the human factor failures associated with preventable ADEs. We also assessed the potential benefits of proved effective ADE prevention strategies on ADE claims prevention. We conducted a retrospective analysis of a New England malpractice insurance company claims records from January 1, 1990, to December 31, 1999. Cases were electronically screened for possible ADEs and followed up by independent review of abstracts by 2 physician reviewers (T.K.G. and R.K.). Additional in-depth claims file reviews identified potential human factor failures associated with ADEs. Adverse drug events represented 6.3% (129/2040) of claims. Adverse drug events were judged preventable in 73% (n = 94) of the cases and were nearly evenly divided between outpatient and inpatient settings. The most frequently involved medication classes were antibiotics, antidepressants or antipsychotics, cardiovascular drugs, and anticoagulants. Among these ADEs, 46% were life threatening or fatal. System deficiencies and performance errors were the most frequent cause of preventable ADEs. The mean costs of defending malpractice claims due to ADEs were comparable for nonpreventable inpatient and outpatient ADEs and preventable outpatient ADEs (mean, $64,700-74,200), but costs were considerably greater for preventable inpatient ADEs (mean, $376,500). Adverse drug events associated with malpractice claims were often severe, costly, and preventable, and about half occurred in outpatients. Many interventions could potentially have prevented ADEs, with error proofing and process standardization covering the greatest proportion of events.

Registry and health insurance claims data in vascular research and quality improvement.

Science.gov (United States)

Behrendt, Christian-Alexander; Heidemann, Franziska; Rieß, Henrik Christian; Stoberock, Konstanze; Debus, Sebastian Eike

2017-01-01

The expansion of procedures in multidisciplinary vascular medicine has sparked a controversy regarding measures of quality improvement. In addition to primary registries, the use of health insurance claims data is becoming of increasing importance. However, due to the fact that health insurance claims data are not collected for scientific evaluation but rather for reimbursement purposes, meticulous validation is necessary before and during usage in research and quality improvement matters. This review highlights the advantages and disadvantages of such data sources. A recent comprehensive expert opinion panel examined the use of health insurance claims data and other administrative data sources in medicine. Results from several studies concerning the validity of administrative data varied significantly. Validity of these data sources depends on the clinical relevance of the diagnoses considered. The rate of implausible information was 0.04 %, while the validity of the considered diagnoses varied between 80 and 97 % across multiple validation studies. A matching study between health insurance claims data of the third-largest German health insurance provider, DAK-Gesundheit, and a prospective primary registry of the German Society for Vascular Surgery demonstrated a good level of validity regarding the mortality of endovascular and open surgical treatment of abdominal aortic aneurysm in German hospitals. In addition, a large-scale international comparison of administrative data for the same disorder presented important results in treatment reality, which differed from those from earlier randomized controlled trials. The importance of administrative data for research and quality improvement will continue to increase in the future. When discussing the internal and external validity of this data source, one has to distinguish not only between its intended usage (research vs. quality improvement), but also between the included diseases and/or treatment procedures

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to acetic acid and maintenance of normal blood pressure (ID 1447) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

that maintenance of normal blood pressure is a beneficial physiological effect. In weighing the evidence, the Panel took into account that although one animal study showed an effect of acetic acid administration on systolic blood pressure, results from two human intervention studies are conflicting...... claims in relation to acetic acid and maintenance of normal blood pressure. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders....... The food that is the subject of the health claim is apple vinegar drink. From the references provided for the scientific substantiation of the claim, the Panel assumes that the food constituent which is responsible for the claimed effect is acetic acid. The Panel considers that acetic acid is sufficiently...

Insulin resistance as key factor for linking modulation of gut microbiome to health claims and dietary recommendations to tackle obesity

NARCIS (Netherlands)

Loman, S.; Kamp, J.W. van der

2016-01-01

Background: Current dietary and public health recommendations addressing obesity do not as yet include recommendations pertaining to the gut microbiome. As a corollary, no microbiome-related health claims made on foods have as yet been proposed. Scope: The MyNewGut project aims, amongst others, to

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to foods with reduced lactose content and decreasing gastro-intestinal discomfort caused by lactose intake in lactose intolerant individuals (ID 646, 1224, 1238, 1339

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to foods with reduced lactose content and decreasing gastro-intestinal discomfort caused by lactose intake in lactose intolerant individuals. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims...... and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is lactose, which should be “decreased” or “reduced” in foods in order to obtain the claimed effect. The Panel considers that lactose is sufficiently characterised....... The claimed effects are “lactose intolerance”, “decrease lactose malabsorption symptoms” and “lactose digestion”. The target population is assumed to be lactose intolerant individuals. The Panel assumes that the claimed effects refer to decreasing gastro-intestinal discomfort caused by lactose intake...

FSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Guidance on the scientific requirements for health claims related to functions of the ne rvous system, including psycholog ical functions

DEFF Research Database (Denmark)

Tetens, Inge

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to draft guidance on scientific requirements for health claims related to functions of the nervous system, including psychological functions. This guidance has been drawn from scientific opinions......, and was released for public consultation from 17 October 2011 to 16 December 2011....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to fructo-oligosaccharides (FOS) and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 781), pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to fructo-oligosaccharides and decreasing potentially pathogenic gastro-intestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... conclusions could be drawn for the scientific substantiation of the claim were provided. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of fructo-oligosaccharides and decreasing potentially pathogenic gastro...

Scientific Opinion on the substantiation of a health claim related to SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation pursuant to Article 13(5) of Regulation (EC) No

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following an application from Synbiotec S.r.l., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the s......Following an application from Synbiotec S.r.l., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... on the scientific substantiation of a health claim related to SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation. The Panel considers that the food, SYNBIO®, which is the subject of the health claim, is sufficiently characterised...... that no evidence was provided that the tools used to assess changes in bowel habits in response to an intervention were valid. Therefore, no conclusions could be drawn from these studies for the scientific substantiation of a claim on SYNBIO® and maintenance of normal defecation. In the absence of evidence...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum sweetened with xylitol and plaque acid neutralisation (ID 485), maintenance of tooth mineralisation (ID 486, 562, 1181), reduction of dental

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to sugar-free chewing gum sweetened with xylitol and plaque acid neutralisation, maintenance of tooth mineralisation, reduction of dental plaque, and defence against pathogens in the middle ear. The scientific substantiation is based on the information provided by the Member States...... in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claims is sugar-free chewing gum sweetened with xylitol. The Panel considers that sugar-free chewing gum sweetened with xylitol...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to coffee C21 and reduction of spontaneous DNA strand breaks pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

of coffee compared to water on spontaneous DNA strand breaks. The evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of coffee C21 consumption on the reduction of spontaneous DNA strand breaks in humans. The Panel concludes that a cause and effect......Following an application from Tchibo GmbH, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related...... to coffee C21 and reduction of spontaneous DNA strand breaks. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is coffee C21, which is sufficiently characterised. The claimed...

Health risk factors as predictors of workers' compensation claim occurrence and cost

Science.gov (United States)

Schwatka, Natalie V; Atherly, Adam; Dally, Miranda J; Fang, Hai; vS Brockbank, Claire; Tenney, Liliana; Goetzel, Ron Z; Jinnett, Kimberly; Witter, Roxana; Reynolds, Stephen; McMillen, James; Newman, Lee S

2017-01-01

Objective The objective of this study was to examine the predictive relationships between employee health risk factors (HRFs) and workers' compensation (WC) claim occurrence and costs. Methods Logistic regression and generalised linear models were used to estimate the predictive association between HRFs and claim occurrence and cost among a cohort of 16 926 employees from 314 large, medium and small businesses across multiple industries. First, unadjusted (HRFs only) models were estimated, and second, adjusted (HRFs plus demographic and work organisation variables) were estimated. Results Unadjusted models demonstrated that several HRFs were predictive of WC claim occurrence and cost. After adjusting for demographic and work organisation differences between employees, many of the relationships previously established did not achieve statistical significance. Stress was the only HRF to display a consistent relationship with claim occurrence, though the type of stress mattered. Stress at work was marginally predictive of a higher odds of incurring a WC claim (p<0.10). Stress at home and stress over finances were predictive of higher and lower costs of claims, respectively (p<0.05). Conclusions The unadjusted model results indicate that HRFs are predictive of future WC claims. However, the disparate findings between unadjusted and adjusted models indicate that future research is needed to examine the multilevel relationship between employee demographics, organisational factors, HRFs and WC claims. PMID:27530688

Do consumers prefer foods with nutrition and health claims? Results of a purchase simulation

DEFF Research Database (Denmark)

Aschemann-Witzel, Jessica; Hamm, U.

2010-01-01

This contribution reports findings of a close-to-realistic purchase simulation for foods labelled with nutrition and health claims. The results show that products with a claim are clearly preferred, but that the determining factors of choice differ between the food categories. Choice was positively...

Reviewing the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What do we know about its challenges and potential impact on innovation?

Science.gov (United States)

Bröring, Stefanie; Khedkar, Sukhada; Ciliberti, Stefano

2017-02-01

Health claims potentially represent an opportunity for firms to engage in product differentiation and thereby induce investment into R&D and innovation in the food sector. The Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) aims at protecting and promoting innovation as one of its objectives. However, existing studies indicate that this regulation may create several challenges for innovation in the food sector. To this end, we review the challenges related to the NHCR (Article 13.1) and its impact on innovation. Extant literature suggests that companies face challenges related to changing list of ingredients, missing transparency, wording of claims, limited financial resources, limited R&D resources, switching product categories and abandoning the functional foods sector. Moreover, current studies imply that so far the NHCR (in specific Article 13.1) does not seem to encourage innovation in the EU food sector.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sodium alginate and reduction of post-prandial glycaemic responses (ID 1868, 1881) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to sodium alginate and reduction of post-prandial glycaemic responses. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... from which conclusions could be drawn for the scientific substantiation of the claim did not show a reduction in post-prandial glycaemic responses without a disproportionate increase in post-prandial insulinaemic responses following consumption of sodium alginate. On the basis of the data presented...

Predicting Consumer Effort in Finding and Paying for Health Care: Expert Interviews and Claims Data Analysis.

Science.gov (United States)

Long, Sandra; Monsen, Karen A; Pieczkiewicz, David; Wolfson, Julian; Khairat, Saif

2017-10-12

For consumers to accept and use a health care information system, it must be easy to use, and the consumer must perceive it as being free from effort. Finding health care providers and paying for care are tasks that must be done to access treatment. These tasks require effort on the part of the consumer and can be frustrating when the goal of the consumer is primarily to receive treatments for better health. The aim of this study was to determine the factors that result in consumer effort when finding accessible health care. Having an understanding of these factors will help define requirements when designing health information systems. A panel of 12 subject matter experts was consulted and the data from 60 million medical claims were used to determine the factors contributing to effort. Approximately 60 million claims were processed by the health care insurance organization in a 12-month duration with the population defined. Over 292 million diagnoses from claims were used to validate the panel input. The results of the study showed that the number of people in the consumer's household, number of visits to providers outside the consumer's insurance network, number of adjusted and denied medical claims, and number of consumer inquiries are a proxy for the level of effort in finding and paying for care. The effort level, so measured and weighted per expert panel recommendations, differed by diagnosis. This study provides an understanding of how consumers must put forth effort when engaging with a health care system to access care. For higher satisfaction and acceptance results, health care payers ideally will design and develop systems that facilitate an understanding of how to avoid denied claims, educate on the payment of claims to avoid adjustments, and quickly find providers of affordable care. ©Sandra Long, Karen A. Monsen, David Pieczkiewicz, Julian Wolfson, Saif Khairat. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 12.10.2017.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to lactose and increase in calcium absorption leading to an increase in calcium retention (ID 668) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to lactose and increase in calcium absorption leading to an increase in calcium retention. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member...... States or directly from stakeholders. The food constituent that is the subject of the health claim is lactose. The Panel considers that lactose is sufficiently characterised. The claimed effect is “calcium absorption”. The target population is assumed to be the general population. The Panel notes...... between the consumption of lactose and an increase in calcium absorption leading to an increase in calcium retention....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to fructose and reduction of post-prandial glycaemic responses (ID 558) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

OpenAIRE

Tetens, Inge

2011-01-01

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to fructose and reduction of post-prandial glycaemic responses. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Arti...

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

Science.gov (United States)

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.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the substantiation of a health claim related to β-galactosidase from Kluyveromyces lactis in Colief® and a reduction of gastrointestinal discomfort pursuant to Article 14 of Regulation (EC

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

provided in the publication and that supplied later by the applicant was inadequate to allow a scientific evaluation. The second study with methodological limitations showed an effect of the food on crying time in infants fed exclusively with milk. This study also provided some evidence for the proposed...... an opinion on the scientific substantiation of a health claim related to β-galactosidase from Kluyveromyces lactis in Colief® and a reduction of gastrointestinal discomfort. The Panel considers that the food is sufficiently characterised in relation to the claimed effect. A reduction of gastrointestinal...... discomfort is a beneficial physiological effect for infants and young children. The applicant provided two human intervention studies for the substantiation of the health claim. No conclusions could be drawn from one of the two studies for the scientific substantiation of the claim, as the information...

Lactitol and the maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2015-01-01

that the maintenance of normal defecation is a beneficial physiological effect. A total of 15 human intervention studies were identified as pertinent to the health claim. Twelve studies with various methodological limitations consistently showed that consumption of at least 10 g/day lactitol increases stool frequency......Following an application from DuPont Nutrition BioSciences ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to lactitol and the maintenance of normal defecation. The food constituent that is the subject of the claim is lactitol. The Panel considers that the food constituent lactitol, which is the subject of the claim, is sufficiently characterised. The Panel considers...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Vitis vinifera L. seeds extract and “helps to decrease swollen legs” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to Vitis vinifera L. seeds extract and “helps to decrease swollen legs”. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. Upon EFSA’s request for clarification, the applicant stated that the claimed effect was “helps to decrease...

Medicalisation of food advertising: Nutrition and health claims in magazine food advertisements 1900-2008

NARCIS (Netherlands)

Zwier, S.

2009-01-01

Food advertising increasingly portrays food as a type of medicine. A content analysis of magazine food advertisements in 1990 through 2008 shows that this was manifested with time more in the (a) nutrition claims and (b) health claims made in food advertisements, as well as the (c) food groups and

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

Science.gov (United States)

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.

Resolving Malpractice Claims after Tort Reform: Experience in a Self-Insured Texas Public Academic Health System.

Science.gov (United States)

Sage, William M; Harding, Molly Colvard; Thomas, Eric J

2016-12-01

To describe the litigation experience in a state with strict tort reform of a large public university health system that has committed to transparency with patients and families in resolving medical errors. Secondary data collected from The University of Texas System, which self-insures approximately 6,000 physicians at six health campuses across the state. We obtained internal case management data for all medical malpractice claims closed during 1 year before and 6 recent years following the enactment of state tort reform legislation. We retrospectively reviewed information about malpractice claimants, malpractice claims, and the process and outcome of dispute resolution. We accessed an internal case management database, supplemented by both electronic and paper records compiled by the university's Office of General Counsel. Closed claims dropped from 244 in 2001-2002 to an annual mean of 96 in 2009-2015, closures following lawsuits from 136 in 2001-2002 to an annual mean of 28 in 2009-2015, and paid claims from 60 in 2001 to an annual mean of 20 in 2009-2015. Patterns of resolution suggest efforts by the university to provide some compensation to injured patients in cases that were no longer economically viable for plaintiffs' lawyers to litigate. The percentage of payments relating to cases in which lawsuits had been filed decreased from 82 percent in 2001-2002 to 47 percent in 2009-2012 and again to 29 percent in 2012-2015, although most paid claimants were represented by attorneys. Unrepresented patients received payment in 13 cases closed in 2009-2012 (22 percent of payments; mean amount $60,566) and in 24 cases closed in 2012-2015 (41 percent of payments; mean amount $109,410). Even after tort reform, however, claims that resulted in payment remained slow to resolve, which was worsened for claimants subject to Medicare secondary payer rules. Strict confidentiality became a more common condition of settlement, although restrictions were subsequently relaxed

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the sci......Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... on the scientific substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm......®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation...

[Health claims for medical foods].

Science.gov (United States)

Katan, Martijn B

2013-01-01

Souvenaid (Nutricia, Zoetermeer, the Netherlands) is a medical food for the dietary management of early Alzheimer's disease. The mix of nutrients in this drink is suggested to have a beneficial effect on cognitive function; such implicit health claims for medical foods are not checked by government agencies. Souvenaid has been investigated in three clinical trials. The first trial showed that Souvenaid produced a significant improvement in delayed verbal recall, but not in other psychological tests. The second and largest trial showed no effect on any outcome. The third trial showed no significant effect at 12 or 24 weeks, but a significant difference in the 24-week time course of the composite memory score. None of these outcomes was clearly specified as a primary outcome at trial registration. In conclusion, there is no convincing proof that Souvenaid benefits cognitive function. Better scrutiny of the efficacy of medical foods is warranted.

Health claims on food products in Southeast Asia: regulatory frameworks, barriers, and opportunities.

Science.gov (United States)

Tan, Karin Y M; van der Beek, Eline M; Chan, M Y; Zhao, Xuejun; Stevenson, Leo

2015-09-01

The Association of Southeast Asian Nations aims to act as a single market and allow free movement of goods, services, and manpower. The purpose of this article is to present an overview of the current regulatory framework for health claims in Southeast Asia and to highlight the current barriers and opportunities in the regulatory frameworks in the Association of Southeast Asian Nations. To date, 5 countries in Southeast Asia, i.e., Indonesia, Malaysia, the Philippines, Singapore, and Thailand, have regulations and guidelines to permit the use of health claims on food products. There are inconsistencies in the regulations and the types of evidence required for health claim applications in these countries. A clear understanding of the regulatory frameworks in these countries may help to increase trade in this fast-growing region and to provide direction for the food industry and the regulatory community to develop and market food products with better nutritional quality tailored to the needs of Southeast Asian consumers. © The Author(s) 2015. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to glucosamine and maintenance of normal joint cartilage pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Merck Consumer Healthcare, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health...... claim related to glucosamine, formulated as glucosamine sulphate or hydrochloride, and maintenance of normal joint cartilage. Glucosamine is sufficiently characterised. The claimed effect is “contributes to the maintenance of normal joint cartilage”. The target population as proposed by the applicant...... to studies in patients with osteoarthritis, in healthy subjects, in animals and in vitro as being pertinent to the health claim. In weighing the evidence, the Panel took into account that no human studies were provided from which conclusions could be drawn on the effect of dietary glucosamine...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to beta-palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...... to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial...... physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL - cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

on the scientific substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations. The food, monacolin K in SYLVAN BIO red yeast rice, that is the subject of the health claim is sufficiently characterised. The claimed effect......, maintenance of normal blood LDL-cholesterol concentrations, is a beneficial physiological effect. A claim on monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome at daily intakes of 10 mg monacolin K from any red...... on blood LDL-cholesterol concentrations. © European Food Safety Authority, 2013...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to carbonate and bicarbonate salts of sodium and potassium and maintenance of normal bone (ID 331, 1402) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to carbonate and bicarbonate salts of sodium and potassium and maintenance of normal bone. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member...... States or directly from stakeholders. The food constituents that are the subject of the health claim are carbonate and bicarbonate salts of sodium and potassium. The Panel considers that carbonate and bicarbonate salts of sodium and potassium are sufficiently characterised. The claimed effects are “acid...... the dietary intake of carbonate or bicarbonate salts of sodium or potassium and maintenance of normal bone....

EFSA Panel on Di etetic Products, Nutrition and Allergie s (NDA); Scientific Opinion on the substantiation of a health claim relate d to OXY 280 and reduction of body weight pur suant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Actina, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related...... relative to the placebo, and that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel notes that no studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause...

Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2)

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim published in 2011. Since then, the NDA Panel has gained considerable experience...... developments in this area. This guidance document presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims which fall under Articles 13(5), 14 and 19 of Regulation (EC) No 1924/2006. This guidance outlines...... the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and gamma-linolenic acid (GLA) and contribution to normal cognitive function (ID 532) and maintenance

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and gamma-linolenic acid (GLA) and contribution to normal cognitive function and maintenance of normal bone. The scientific substantiation is based on the information provided by the Member States in the consolidated list...... and fish oil”. From the references provided, the Panel assumes that the food constituents that are the subject of the claims are the n-6 fatty acid gamma-linolenic acid (GLA) in evening primrose oil and the n-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA...... of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituents that are the subjects of the health claims are “omega-3 and omega-6 fatty acids (GLA)”, “gamma-linolenic acid + eicosapentaenoic acid (GLA+EPA)”, and “evening primrose oil...

The effect of health/hedonic claims on consumer hedonic and sensory perception of sugar reduction: Case study with orange/passionfruit nectars.

Science.gov (United States)

Oliveira, Denize; Ares, Gastón; Deliza, Rosires

2018-06-01

Sugar reduction in beverages can contribute to reduce consumption of this nutrient and to improve the health status of the population. However, such reduction can negatively affect consumer perception. Label information can be an effective tool to increase consumer interest in sugar-reduced products. In this context, the aim of the present work was to study the influence of health/hedonic claims on consumer hedonic and sensory perception of sugar reduction in orange/passionfruit nectars under expected and informed conditions. Sugar-reduced orange/passionfruit nectars (20% and 40% reduced in added sugar) featuring different claims (none, health claim or hedonic claim) were evaluated, together with a control product without reduction. Following a between-subjects experimental design, 206 participants evaluated the nectars under two experimental conditions: (a) expected, looking at the packages, and (b) informed, looking at the packages and tasting the nectars. In each experimental condition, participants evaluated their overall liking using a 9-point hedonic scale and answered a check-all-that-apply questions related to the sensory characteristics of the nectars. Results showed that although consumers did not have negative expectations about sugar-reduced nectars, the sensory characteristics of the products were the main determinants of consumers' hedonic reaction towards the nectars. The influence of claims on consumers' perception was modulated by their hedonic sensitivity towards sugar-reduction. The hedonic claim increased overall liking of those consumers with low hedonic sensitivity towards sugar reduction, whereas it had the opposite effect on the most sensitive consumers. Results from the present work suggest that although hedonic claims hold potential for a consumer segment, care must be taken to avoid the generation of unrealistic expectations about the sensory characteristics of sugar-reduced products. Copyright © 2018 Elsevier Ltd. All rights reserved.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies ), 2013. Scientific Opinion on the substantiation of a health claim related to Yestimun ® and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of R egulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

substantiation of a health claim related to Yestimun® and defence against pathogens in the upper respiratory tract. The food that is the subject of the health claim, Yestimun®, which consists of (1,3)-(1,6)-β-D-glucans from brewer’s yeast cell wall, is sufficiently characterised. The claimed effect, defence...... established between the consumption of Yestimun® ((1,3)-(1,6)-β-D-glucans from brewer’s yeast cell wall) and defence against pathogens in the upper respiratory tract. © European Food Safety Authority, 2013...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to formulated palm and oat oil emulsion and contribution to the maintenance or achievement of a normal body weight (ID 577) and maintenance of body weight after weight

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to formulated palm and oat oil emulsion and contribution to the maintenance or achievement of a normal body weight and maintenance of body weight after weight loss. The scientific substantiation is based on the information provided by the Member States in the consolidated list...... of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is formulated palm and oat oil emulsion. The Panel considers that formulated palm and oat oil emulsion is sufficiently...

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

OpenAIRE

Kim, Ji Yeon; Kang, Eun Jin; Kwon, Oran; Kim, Gun-Hee

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 sign...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to glycaemic carbohydrates and maintenance of normal brain function (ID 603, 653) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

; attention; memory”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal brain function. The Panel considers that maintenance of normal brain function is a beneficial...... claims in relation to glycaemic carbohydrates and maintenance of normal brain function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2013. Scientific Opinion on the substantiation of a health claim related to Transitech ® and improvement of bowel function which is maintained after cessation of consumption of the food pursuant to Article 13

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Vivatech, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientif...... of the food. A cause and effect relationship has not been established between the consumption of Transitech® and improvement of bowel function which is maintained after cessation of consumption of the food. © European Food Safety Authority, 2013...... substantiation of a health claim related to Transitech® and improvement of bowel function which is maintained after cessation of consumption of the food. The food, Transitech®, that is the subject of the health claim is sufficiently characterised. The claimed effect, improvement of bowel function which...... is maintained after cessation of consumption of the food, is a beneficial physiological effect. In weighing the evidence, the Panel considered that the one study that investigated the claimed effect did not show an effect of Transitech® on bowel function which is maintained after cessation of consumption...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Vitis vinifera L. seeds extract and maintenance of normal venous blood flow pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to Vitis vinifera L. seeds extract and maintenance of normal venous blood flow. The Panel considers that the food constituent, which is the subject of the health claim, is sufficiently characterised. The claimed effect, maintenance of normal venous blood flow, is a beneficial physiological effect...... and did not measure venous blood flow, the Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Vitis vinifera L. seeds extract...

A report on 15 years of clinical negligence claims in rhinology.

Science.gov (United States)

Geyton, Thomas; Odutoye, Tunde; Mathew, Rajeev

2014-01-01

This study was designed to determine the characteristics of medical negligence claims in rhinology. In 2010-2011 the National Health Service (NHS) litigation bill surpassed 1 billion Great British Pounds (GBP; 1.52 billion U.S. dollars [US$]). Systematic analysis of malpractice complaints allows for the identification of errors and can thereby improve patient safety and reduce the burden of litigation claims on health services. Claims relating to ear, nose, and throat between 1995 and 2010 were obtained from the NHS Litigation Authority and were analyzed. The series contains 65 closed claims that resulted in payment totaling 3.1 million GBP (US$4.7 million). Fifty claims were related to surgical complications. Functional endoscopic sinus surgery and septoplasty were the procedures most commonly associated with successful claims. There were 11 cases of orbital injury including 6 cases of visual loss and 5 cases of diplopia. The most common cause of a claim was failure to recognize the complication or manage it appropriately. Lack of informed consent was claimed in eight cases. Other claims arose because of errors in outpatient procedures (two), diagnosis (six), delayed surgery (one), and errors in medical management (three). This is the first study to report the outcomes of negligence claims in rhinology in the United Kingdom. Claims in rhinology are associated with a high success rate. Steps that can be taken to reduce litigation include careful patient workup and ensuring adequate informed consent. Where there is a suspicion of orbital damage early recognition and intervention is needed to reduce long-term injury to the patient.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus rhamnosus CNCM I-1720 and Lactobacillus helveticus CNCM I-1722 and defence against pathogenic gastro-intestinal microorganisms (ID 939

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim related to a combination of Lactobacillus rhamnosus CNCM I-1720 and Lactobacillus helveticus CNCM I-1722 and defence against...... pathogenic gastro-intestinal microorganisms. The food constituent that is the subject of the health claim, a combination of Lactobacillus rhamnosus CNCM I-1720 and Lactobacillus helveticus CNCM I-1722, is sufficiently characterised. The claimed effect, defence against pathogenic gastro...... and effect relationship has not been established between the consumption of a combination of Lactobacillus rhamnosus CNCM I-1720 and Lactobacillus helveticus CNCM I-1722 and defence against pathogenic gastro-intestinal microorganisms....

The effectiveness of insurer-supported safety and health engineering controls in reducing workers' compensation claims and costs.

Science.gov (United States)

Wurzelbacher, Steven J; Bertke, Stephen J; Lampl, Michael P; Bushnell, P Timothy; Meyers, Alysha R; Robins, David C; Al-Tarawneh, Ibraheem S

2014-12-01

This study evaluated the effectiveness of a program in which a workers' compensation (WC) insurer provided matching funds to insured employers to implement safety/health engineering controls. Pre- and post-intervention WC metrics were compiled for the employees designated as affected by the interventions within 468 employers for interventions occurring from 2003 to 2009. Poisson, two-part, and linear regression models with repeated measures were used to evaluate differences in pre- and post-data, controlling for time trends independent of the interventions. For affected employees, total WC claim frequency rates (both medical-only and lost-time claims) decreased 66%, lost-time WC claim frequency rates decreased 78%, WC paid cost per employee decreased 81%, and WC geometric mean paid claim cost decreased 30% post-intervention. Reductions varied by employer size, specific industry, and intervention type. The insurer-supported safety/health engineering control program was effective in reducing WC claims and costs for affected employees. © 2014 Wiley Periodicals, Inc.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to anthocyanins from Ribes nigrum L. and improvement of visual adaptation to the dark (ID 2750) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to anthocyanins from Ribes nigrum L. and improvement of visual adaptation to the dark. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States...... or directly from stakeholders. The food constituent that is the subject of the health claim is anthocyanins from Ribes nigrum L. The Panel considers that anthocyanins from Ribes nigrum L. are sufficiently characterised. The claimed effect is “eye health”. The target population is assumed to be the general...... population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to an improvement of visual adaptation to the dark. The Panel considers that improvement of visual adaptation to the dark is a beneficial physiological effect. No human studies were provided from which...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Sc ientific Opinion on the substantiation of a health claim related to Vichy Catalan carbonated natural mineral water and reduction of post - prandial lip a emic response pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

on the scientific substantiation of a health claim related to Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response. The food, Vichy Catalan carbonated natural mineral water, that is the subject of the health claim is sufficiently characterised. The claimed effect...... carbonated natural mineral water on the reduction of post-prandial lipaemic response. A cause and effect relationship has not been established between the consumption of Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response. © European Food Safety Authority, 2013......Following an application from S.A. Vichy Catalan, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to “αS1-casein tryptic hydrolysate” and alleviation of psychological stress (ID 656, 1819, 4253) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to “αS1-casein tryptic hydrolysate” and alleviation of psychological stress. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... that alleviation of psychological stress might be a beneficial physiological effect. No references were provided from which conclusions could be drawn for the scientific substantiation of the claim. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been...

Black tea and maintenance of normal endotheliumdependent vasodilation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2018-01-01

on the scientific substantiation of a health claim related to black tea and maintenance of normal endotheliumdependent vasodilation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health...... claim is black tea beverages, either freshly prepared or reconstituted from water extract powders of black tea, characterised by the content of flavanols (expressed as catechins plus theaflavins) of at least 30 mg per 200 mL serving. The Panel considers that black tea characterised by the content....... Of the five human intervention studies provided on the chronic effect of black tea consumption on endothelium-dependent vasodilation, two investigated the effect after regular consumption of black tea for a sufficiently long time period (i.e. at least 4 weeks). These two studies did not allow an effect...

Medicaid Drug Claims Statistics

Data.gov (United States)

U.S. Department of Health & Human Services — The Medicaid Drug Claims Statistics CD is a useful tool that conveniently breaks up Medicaid claim counts and separates them by quarter and includes an annual count.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014 . Scientific Opinion on the substantiation of a health claim related to vitamin C and increasing non-haem iron absorption pursuant to Article 14 of Regulation (EC ) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

to deliver an opinion on the scientific substantiation of a health claim related to vitamin C and increasing non haem iron absorption. The food constituent, vitamin C, which is the subject of the health claim, is sufficiently characterised. Increasing non haem iron absorption is a beneficial physiological...... effect for infants and young children. A claim on vitamin C and increasing non haem iron absorption in the general population has already been assessed by the Panel with a favourable outcome. The Panel considers that the role of vitamin C in increasing non haem iron absorption applies to all ages......, including infants and young children (from birth to three years). The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin C and increasing non haem iron absorptions....

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to Preservation ® and “ rapid recovery of cellular activity post stress ” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from ICP Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Malta, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to Preservation® and “rapid recovery of cellular activity post stress”. The Panel considers that Preservation®, which contains an extract of prickly pear cactus Opuntia ficus-indica, is sufficiently characterised. The claimed effect is “rapid recovery of cellular activity...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Saccharomyces cerevisiae var. boulardii CNCM I-3799 and reducing gastrointestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

substantiation of a health claim related to Saccharomyces cerevisiae var. boulardii CNCM I-3799 and reducing gastro-intestinal discomfort. The food constituent that is the subject of the health claim, S. cerevisiae var. boulardii CNCM I-3799, is sufficiently characterised. The claimed effect, reduction of gastro....... cerevisiae var. boulardii CNCM I-3799), except for two animal studies and one in vitro study. Upon an EFSA request, the applicant indicated that the rest of the studies provided were conducted with the strain produced by Biocodex Laboratories (S. cerevisiae var. boulardii HANSEN CBS 5926). The applicant also...... stated that the strain, which is the subject of the claim, S. cerevisiae var. boulardii CNCM I-3799, is equivalent to S. cerevisiae var. boulardii HANSEN CBS 5926, based on a comparative PCR inter-delta element analysis of both strains provided in the application. The Panel considered that the evidence...

Analysis of clinical negligence claims following tonsillectomy in England 1995 to 2010.

Science.gov (United States)

Mathew, Rajeev; Asimacopoulos, Eleni; Walker, David; Gutierrez, Tatiana; Valentine, Peter; Pitkin, Lisa

2012-05-01

We determined the characteristics of medical negligence claims following tonsillectomy. Claims relating to tonsillectomy between 1995 and 2010 were obtained from the National Health Service Litigation Authority database. The number of open and closed claims was determined, and data were analyzed for primary injury claimed, outcome of claim, and associated costs. Over 15 years, there were 40 claims of clinical negligence related to tonsillectomy, representing 7.7% of all claims in otolaryngology. There were 34 closed claims, of which 32 (94%) resulted in payment of damages. Postoperative bleeding was the most common injury, with delayed recognition and treatment of bleeding alleged in most cases. Nasopharyngeal regurgitation as a result of soft palate fistulas or excessive tissue resection was the next-commonest cause of a claim. The other injuries claimed included dentoalveolar injury, bums, tonsillar remnants, and temporomandibular joint dysfunction. Inadequate informed consent was claimed in 5 cases. Clinical negligence claims following tonsillectomy have a high success rate. Although postoperative bleeding is the most common cause of negligence claims, a significant proportion of claims are due to rare complications of surgery. Informed consent should be tailored to the individual patient and should include a discussion of common and serious complications.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to carbohydrate solutions and maintenance of physical performance during endurance exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from the British Specialist Nutrition Association Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies...... (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and maintenance of physical performance during endurance exercise. The food, which is proposed by the applicant to be the subject of the health claim, is “carbohydrate solutions...... of physical performance during endurance exercise as compared to “water–electrolyte solutions” cannot be established on the basis of the information provided. Maintenance of physical performance during endurance exercise is a beneficial physiological effect. Three meta-analyses of human intervention studies...

The Impact of Nutrition and Health Claims on Consumer Perceptions and Portion Size Selection: Results from a Nationally Representative Survey

Science.gov (United States)

Benson, Tony; Lavelle, Fiona; McCloat, Amanda; Mooney, Elaine; Egan, Bernadette; Collins, Clare E.; Dean, Moira

2018-01-01

Nutrition and health claims on foods can help consumers make healthier food choices. However, claims may have a ‘halo’ effect, influencing consumer perceptions of foods and increasing consumption. Evidence for these effects are typically demonstrated in experiments with small samples, limiting generalisability. The current study aimed to overcome this limitation through the use of a nationally representative survey. In a cross-sectional survey of 1039 adults across the island of Ireland, respondents were presented with three different claims (nutrition claim = “Low in fat”; health claim = “With plant sterols. Proven to lower cholesterol”; satiety claim = “Fuller for longer”) on four different foods (cereal, soup, lasagne, and yoghurt). Participants answered questions on perceived healthiness, tastiness, and fillingness of the products with different claims and also selected a portion size they would consume. Claims influenced fillingness perceptions of some of the foods. However, there was little influence of claims on tastiness or healthiness perceptions or the portion size selected. Psychological factors such as consumers’ familiarity with foods carrying claims and belief in the claims were the most consistent predictors of perceptions and portion size selection. Future research should identify additional consumer factors that may moderate the relationships between claims, perceptions, and consumption. PMID:29789472

The Impact of Nutrition and Health Claims on Consumer Perceptions and Portion Size Selection: Results from a Nationally Representative Survey

Directory of Open Access Journals (Sweden)

Tony Benson

2018-05-01

Full Text Available Nutrition and health claims on foods can help consumers make healthier food choices. However, claims may have a ‘halo’ effect, influencing consumer perceptions of foods and increasing consumption. Evidence for these effects are typically demonstrated in experiments with small samples, limiting generalisability. The current study aimed to overcome this limitation through the use of a nationally representative survey. In a cross-sectional survey of 1039 adults across the island of Ireland, respondents were presented with three different claims (nutrition claim = “Low in fat”; health claim = “With plant sterols. Proven to lower cholesterol”; satiety claim = “Fuller for longer” on four different foods (cereal, soup, lasagne, and yoghurt. Participants answered questions on perceived healthiness, tastiness, and fillingness of the products with different claims and also selected a portion size they would consume. Claims influenced fillingness perceptions of some of the foods. However, there was little influence of claims on tastiness or healthiness perceptions or the portion size selected. Psychological factors such as consumers’ familiarity with foods carrying claims and belief in the claims were the most consistent predictors of perceptions and portion size selection. Future research should identify additional consumer factors that may moderate the relationships between claims, perceptions, and consumption.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to casein protein hydrolysates and growth or maintenance of muscle mass (ID 1498), increase in endurance performance (ID 660, 1497) and faster recovery from muscle

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to casein protein hydrolysates and growth or maintenance of muscle mass, increase in endurance performance and faster recovery from muscle fatigue after exercise. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to fruits and/or vegetables (ID 1212, 1213, 1214, 1217, 1218, 1219, 1301, 1425, 1426, 1427, 1428, 1429, 1430) and to the “Mediterranean diet” (ID 1423) pursuant

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to fruits and/or vegetables and to the “Mediterranean diet”. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to zinc and “the prevention of bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity” pursuant to Article 13(5) of Regulation (EC

DEFF Research Database (Denmark)

Tetens, Inge

claim related to zinc and “the prevention of bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The claimed effect is “prevents bad breath......Following an application from EJP Pharmaceutical ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health...... by neutralising of volatile sulphur compounds in the mouth and oral cavity”. The target population, as proposed by the applicant, is adults over the age of 18 who wish to improve their bad breath. The Panel considers that the proposed claim is related to breath odour rather than to a function of the body...

Legislation and litigation related to low-level radiation injury claims

International Nuclear Information System (INIS)

McCraw, T.

1985-01-01

Current legislation and litigation related to radiation exposure will have an enormous impact on the radiation protection and monitoring requirements of the future. A brief review of some proposed injury compensation bills for veterans and a recent court decision for low-level radiation injury claims are reviewed

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds and improvement of visual adaptation to the dark (ID 680) pursuant to Article 13(1) of Regulation

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds and improvement of visual adaptation to the dark. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA...... has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds. The Panel considers that OPCs from grape (Vitis vinifera L.) seeds are sufficiently characterised....... The claimed effect is “ocular system: OPCs play an important role in the structure and physiological functions of cornea, OPCs protect the cornea and improve visual adaptation to low luminances”. The target population is assumed to be the general population. In the context of the proposed wordings...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014 . Scientific Opinion on the substantiation of a health claim related to zinc and normal function of the immune system pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

substantiation of a health claim related to zinc and normal function of the immune system. The food constituent, zinc, which is the subject of the health claim is sufficiently characterised. Normal function of the immune system is a beneficial physiological effect for infants and young children. A claim on zinc...... and function of the immune system in the general population has already been assessed with a favourable outcome. The Panel considers that the role of zinc in normal function of the immune system applies to all ages, including infants and young children (from birth to three years). The Panel concludes...... that a cause and effect relationship has been established between the dietary intake of zinc and normal function of the immune system. The following wording reflects the scientific evidence: “zinc contributes to normal function of the immune system”....

FSA Panel on Di etetic Products, Nutrition and Allergie s (NDA); Scientific Opinion on the substantiation of a health claim related to Vitis vinifera L. seeds extract and “helps to drain the body in case of water accumulation” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to Vitis vinifera L. seeds extract and “helps to drain the body in case of water accumulation”. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. The claimed effect proposed by the applicant is “helps to drain the body in case......” was a beneficial physiological effect in the context of “a normal venous circulation in the legs”. The applicant acknowledged that this claim referred to the same physiological function of the body as another health claim application on Vitis vinifera L. seeds extract and maintenance of normal venous blood flow...

Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1)

DEFF Research Database (Denmark)

Tetens, Inge

2011-01-01

The scientific and technical guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies for the preparation and presentation of an application for authorisation of a health claim presents a common format for the organisation of information for the preparation of a well......-structured application for authorisation of health claims which fall under Article 14 (referring to children’s development and health, and to disease risk reduction claims), or 13(5) (which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data......), or for the modification of an existing authorisation in accordance with Article 19 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to olive leaf (Olea europaea L.) water extract and increase in glucose tolerance pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

substantiation of a health claim related to olive (Olea europaea L.) leaf water extract and increase in glucose tolerance. The food that is the subject of the health claim, olive leaf water extract standardised by its content of oleuropein, is sufficiently characterised. The claimed effect, an increase...... is insufficient to establish a cause and effect relationship between the consumption of olive leaf water extract and an increase in glucose tolerance....... in glucose tolerance, is a beneficial physiological effect as long as serum insulin concentrations are not disproportionately increased. One human intervention study showed an increase in glucose tolerance without disproportionate increase in insulin concentrations after daily consumption of the olive leaf...

EFSA Panel on Dietetic Products, Nutrition and Allerg ies (NDA) ; Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations

DEFF Research Database (Denmark)

Tetens, Inge

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. This guidance has been drawn from scientific...... and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out in order to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document, endorsed...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to L-carnitine and faster recovery from muscle fatigue after exercise (ID 738, 1492, 1493), skeletal muscle tissue repair (ID 738, 1492, 1493), increase in endurance

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to L-carnitine and faster recovery from muscle fatigue after exercise, skeletal muscle tissue repair, increase in endurance capacity, maintenance of normal blood LDL-cholesterol concentrations, contribution to normal spermatogenesis, “energy metabolism”, and increasing L...

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

Science.gov (United States)

Kim, Ji Yeon; Kang, Eun Jin; Kwon, Oran; Kim, Gun-Hee

2010-10-01

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 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.

47 CFR 1.1167 - Error claims related to regulatory fees.

Science.gov (United States)

2010-10-01

...) Challenges to determinations or an insufficient regulatory fee payment or delinquent fees should be made in writing. A challenge to a determination that a party is delinquent in paying a standard regulatory fee... 47 Telecommunication 1 2010-10-01 2010-10-01 false Error claims related to regulatory fees. 1.1167...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scienti......Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... on the scientific substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise. The Panel considers that citrulline-malate is sufficiently characterised. The claimed effect proposed by the applicant is “improved recovery from muscle fatigue”. Faster recovery...... function. The evidence provided by the applicant did not establish that a faster reduction of blood lactate concentrations through a dietary intervention leads to faster recovery from muscle fatigue by contributing to the restoration of muscle function after exercise. No conclusions could be drawn from...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and reduction of body weight pursuant

DEFF Research Database (Denmark)

Tetens, Inge

related to a combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and reduction of body weight. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. The claimed effect, reduction of body...... between the consumption of a combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and a reduction in body weight. © European Food Safety Authority, 2012...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sodium and potassium salts of citric acid and maintenance of normal bone (ID 330) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to sodium and potassium salts of citric acid and maintenance of normal bone. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly...... from stakeholders. The food constituents that are the subject of the health claim are sodium and potassium salts of citric acid. The Panel considers that sodium and potassium salts of citric acid are sufficiently characterised. The claimed effect is “acid-base balance and bone health”. The target...... using a higher dose of potassium citrate did not show an effect on bone mineral density. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the dietary intake of potassium or sodium salts of citric acid and maintenance of normal...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to riboflavin (vitamin B2) and contribution to normal energy-yielding metabolism pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

substantiation of a health claim related to riboflavin (vitamin B2) and contribution to normal energy-yielding metabolism. The food constituent, riboflavin, which is the subject of the health claim, is sufficiently characterised. Contribution to normal energy-yielding metabolism is a beneficial physiological...... effect for infants and young children. A claim on riboflavin and contribution to normal energy-yielding metabolism in the general population has already been assessed with a favourable outcome. The Panel notes that the role of riboflavin on normal energy-yielding metabolism applies to all ages, including...... infants and young children (from birth to three years). The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and contribution to normal energy-yielding metabolism....

The assessment of performance and self-report validity in persons claiming pain-related disability.

Science.gov (United States)

Greve, Kevin W; Bianchini, Kevin J; Brewer, Steve T

2013-01-01

One third of all people will experience spinal pain in their lifetime and half of these will experience chronic pain. Pain often occurs in the context of a legally compensable event with back pain being the most common reason for filing a Workers Compensation claim in the United States. When financial incentives to appear disabled exist, malingered pain-related disability is a potential problem. Malingering may take the form of exaggerated physical, emotional, or cognitive symptoms and/or under-performance on measures of cognitive and physical capacity. Essential to the accurate detection of Malingered Pain-related Disability is the understanding that malingering is an act of will, the goal of which is to increase the appearance of disability beyond that which would naturally arise from the injury in question. This paper will review a number of Symptom Validity Tests (SVTs) that have been developed to detect malingering in patients claiming pain-related disability and will conclude with a review of studies showing the diagnostic benefit of combining SVT findings from a comprehensive malingering assessment. The utilization of a variety of tools sensitive to the multiple manifestations of malingering increases the odds of detecting invalid claims while reducing the risk of rejecting a valid claim.

76 FR 9525 - Health Claim; Phytosterols and Risk of Coronary Heart Disease

Science.gov (United States)

2011-02-18

... coronary heart disease (CHD), in a manner that is consistent with FDA's February 14, 2003, letter of.... FDA-2000-P-0102, FDA-2000-P-0133, and FDA-2006-P-0033] Health Claim; Phytosterols and Risk of Coronary Heart Disease AGENCY: Food and Drug Administration, HHS. ACTION: Extension of enforcement discretion...

Malpractice claims related to recurrent laryngeal nerve injury: Forensic remarks regarding 15 cases

Directory of Open Access Journals (Sweden)

A. Verzeletti

2016-12-01

Full Text Available Malpractice claims concerning recurrent laryngeal nerve (RLN injuries are often related to thyroid surgery, but they can also involve surgeons of different specialties. Our survey was made considering expert opinions on claims for medical malpractice evaluated at Brescia Institute of Forensic Medicine in Italy during the period 1992–2012. Fifteen cases concerned RLN injury. Malpractice was identified in 10 cases, according to the following conditions: low pre and intra-operative risk of nerve injury, no documentation showing that the nerve was isolated and preserved despite the existence of potential risk factors. An accurate, well written and complete surgical report is the main tool for the expert examination in malpractice claims.

SyncClaimService

Data.gov (United States)

Department of Veterans Affairs — Provides various methods to sync Claim related data for NWQ processing. It includes web operations to get Claims, get Unique Contention Classifications, get Unique...

Consumer understanding, interpretation and perceived levels of personal responsibility in relation to satiety-related claims

NARCIS (Netherlands)

Bilman, E.M.; Kleef, van E.; Mela, D.J.; Hulshof, T.; Trijp, van J.C.M.

2012-01-01

The aim of this study was to explore (a) whether and how consumers may (over-) interpret satiety claims, and (b) whether and to what extent consumers recognize that personal efforts are required to realize possible satiety-related or weight loss benefits. Following means-end chain theory, we

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to beta-palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from IDACE, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to beta...... (middle or beta) position of the glycerol backbone. Beta-palmitate is considered to be sufficiently characterised. The claimed effect is “beta palmitate enrichment contributes to increase calcium absorption”. The target population proposed by the applicant is infants from birth to 12 months of age......, the Panel took into account the biological plausibility of the mechanism by which beta-palmitate could exert the claimed effect and that three small human intervention studies in preterm and term infants provided some evidence that a higher degree of palmitic acid in the sn-2 position of formula...

Consumers’ perception of symbols and health claims as health-related label messages

DEFF Research Database (Denmark)

Carrillo, E.; Fiszman, S.; Lähteenmäki, Liisa

2014-01-01

The package is the first contact between the food and the consumer and an excellent vehicle for communication with the consumer. Visual cues (symbols) on the package can be used to communicate health-related information. Although EU legislation provides for the use of symbols, there could......’s appeal and convincingness in two countries, one Mediterranean (Spain) and the other Scandinavian (Denmark). Four symbols were employed in the study: (1) heart-plus-stethoscope, (2) olives (a symbol often used in Spain but not so much in Denmark), and two not directly linked to food products: (3) active...... of the symbols perceived by the participants was similar in both countries but the culture influenced the connotations attached to the symbols. In addition, the symbols on the packaging were found to be more important than the verbal information....

Knowledge and networks - key sources of power in global health: Comment on "Knowledge, moral claims and the exercise of power in global health".

Science.gov (United States)

Hanefeld, Johanna; Walt, Gill

2015-02-01

Shiffman rightly raises questions about who exercises power in global health, suggesting power is a complex concept, and the way it is exercised is often opaque. Power that is not based on financial strength but on knowledge or experience, is difficult to estimate, and yet it may provide the legitimacy to make moral claims on what is, or ought to be, on global health agendas. Twenty years ago power was exercised in a much less complex health environment. The World Health Organization (WHO) was able to exert its authority as world health leader. The landscape today is very different. Financial resources for global health are being competed for by diverse organisations, and power is diffused and somewhat hidden in such a climate, where each organization has to establish and make its own moral claims loudly and publicly. We observe two ways which allow actors to capture moral authority in global health. One, through power based on scientific knowledge and two, through procedures in the policy process, most commonly associated with the notion of broad consultation and participation. We discuss these drawing on one particular framework provided by Bourdieu, who analyses the source of actor power by focusing on different sorts of capital. Different approaches or theories to understanding power will go some way to answering the challenge Shiffman throws to health policy analysts. We need to explore much more fully where power lies in global health, and how it is exercised in order to understand underlying health agendas and claims to legitimacy made by global health actors today.

Scientific Opinion on the substantiation of a health claim related to FRUIT UP® and a reduction of post-prandial blood glucose responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

on the scientific substantiation of a health claim related to FRUIT UP® and a reduction of post-prandial blood glucose responses. The Panel considers that the food, FRUIT UP®, and the food (i.e. glucose, sucrose) that FRUIT UP® should replace in foods or beverages are both sufficiently characterised in relation...... between the consumption of FRUIT UP® and a reduction of post-prandial glycaemic responses over and above the well-established effect of fructose on reducing post-prandial glycaemic responses when replacing glucose in foods....

Effect of a health claim and personal characteristics on consumer acceptance of fruit juices with different concentrations of açaí (Euterpe oleracea Mart.).

Science.gov (United States)

Sabbe, Sara; Verbeke, Wim; Deliza, Rosires; Matta, Virginia; Van Damme, Patrick

2009-08-01

This study evaluates the effect of a health claim and personal characteristics on the acceptance of two unfamiliar açaí fruit juices that have a low (40% açaí) versus a high (4% açaí) a priori overall liking. Hedonic and sensory measures as well as health- and nutrition-related attribute perceptions and purchase intention were rated before and after health information was presented. Differences in information effects due to interactions with juice type, consumer background attitudes and socio-demographics were investigated. Providing health information yielded a positive, though rather small increase, in overall liking, perceived healthiness and perceived nutritional value of both juices, as well as in their purchase intention. Sensory experiences remained predominant in the acceptance of the fruit juices, although the health claim had a stronger effect on the perceived healthiness and nutritional value of the least-liked juice. Background attitudes and socio-demographic characteristics influenced consumers' acceptance of both unfamiliar fruit juices. Health-oriented consumers were more likely to compromise on taste for an eventual health benefit, though they still preferred the best tasting juice. Consumers with a high food neophobia reported a lower liking for both unfamiliar fruit juices. Older respondents and women were more likely to accept fruit juices that claim a particular health benefit.

Age-related patterns in work-related injury claims from older New Zealanders, 2009-2013: Implications of injury for an aging workforce.

Science.gov (United States)

Lilley, Rebbecca; Jaye, Chrystal; Davie, Gabrielle; Keeling, Sally; Waters, Debra; Egan, Richard

2018-01-01

This study describes the incidence, nature and cause of work-related injuries in older New Zealand workers to understand the risks of work-related injury in this rapidly aging population. Data for the period 2009-2013 from 25,455 injured workers aged 55-79 years, extracted from national work-related injury entitlement claims, were stratified by age group and analysed by sex, industry, injury type and cause. Age-specific claims rates were calculated by year, sex and ethnicity. Patterns of injury differed by age: 70-79 year olds had the highest injury rates and proportion of claims due to falls (45%), for the self-employed (32%), for the agriculture sector (24%), and for fatal injuries (5%). The burden of work-related injuries in older workers, particularly in those aged over 70, will increase with their increasing participation in work. Workplace injury prevention strategies and interventions need to consider the specific characteristics and vulnerabilities of older workers. Copyright © 2017 Elsevier Ltd. All rights reserved.

Considerations for the analysis of longitudinal electronic health records linked to claims data to study the effectiveness and safety of drugs.

Science.gov (United States)

Lin, K J; Schneeweiss, S

2016-08-01

Health insurance claims and electronic health records (EHR) databases have been considered the preferred data sources with which to study drug safety and effectiveness in routine care. Linking claims data to EHR allows researchers to leverage the complementary advantages of each data source to enhance study validity. We propose a framework to evaluate the need for supplementing claims data with EHR and vice versa to optimize outcome ascertainment, exposure assessment, and confounding adjustment. © 2016 American Society for Clinical Pharmacology and Therapeutics.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2014 . Scientific Opinion on the substantiation of a health claim related to Rosbacher drive® and increased attention pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

an opinion on the scientific substantiation of a health claim related to Rosbacher drive® and increased attention. The Panel considers that Rosbacher drive®, which contains natural mineral water plus grape juice, lemon juice, pomegranate juice, elderberry juice, isomaltulose, sucrose, fructose syrup...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) (ID 1010, 1011, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on health claims pursuant to Article 13.1 of Regulation (EC) No 1924/2006 in the framework of further assessment related to Saccharomyces boulardii ATY......-SB-101 and the following claimed effects: "maintains and restores the natural flora" and "modulating both innate and adaptive host immunity to respond against pathogen infection". The food constituent that is the subject of the claims, Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837......), is not sufficiently characterised. On the basis of the data presented, the Panel concludes that a cause and effect relationship cannot be established between the consumption of Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) and the proposed claimed effects....

42 CFR 456.722 - Electronic claims management system.

Science.gov (United States)

2010-10-01

... Electronic Claims Management System for Outpatient Drug Claims § 456.722 Electronic claims management system...'s Medicaid Management Information System (MMIS) applicable to prescription drugs. (ii) Notifying the... 42 Public Health 4 2010-10-01 2010-10-01 false Electronic claims management system. 456.722...

Workplace health and safety regulations: Impact of enforcement and consultation on workers' compensation claims rates in Washington State.

Science.gov (United States)

Baggs, James; Silverstein, Barbara; Foley, Michael

2003-05-01

There has been considerable debate in the public policy arena about the appropriate mix of regulatory enforcement and consultation in achieving desired health and safety behavior across industries. Recently there has been a shift in federal policy toward voluntary approaches and constraining the scope of enforcement programs, although there is little evidence that this might improve health and safety outcomes. To address this, we examined changes in lost time workers compensation claims rates for Washington State employers who had (1) no OSHA State Plan (WISHA) activity, (2) enforcement, (3) consultation, and (4) both types of visits. Compensable claims rates, hours, and WISHA activity were determined for each employer account with a single business location that had payroll hours reported for every quarter from 1997-2000 and more than 10 employees. We used a generalized estimating equations (GEE) approach to Poisson regression to model the association between WISHA activity and claims rate controlling for other external factors. Controlling for previous claims rate and average size, claims rates for employers with WISHA enforcement activity declined 22.5% in fixed site industry SIC codes compared to 7% among employers with no WISHA activity (P 0.10). WISHA consultation activity was not associated with a greater decline in compensable claims rates (-2.3% for fixed sites and +3.5% for non-fixed sites). WISHA activity did not adversely affect worksite survivability through the study period. Enforcement inspections are significantly associated with decreasing compensable workers compensation claims rates especially for fixed site employers. We were unable to identify an association between consultation activities and decreasing claims rates. Copyright 2003 Wiley-Liss, Inc.

Etiology of work-related electrical injuries: a narrative analysis of workers' compensation claims.

Science.gov (United States)

Lombardi, David A; Matz, Simon; Brennan, Melanye J; Smith, Gordon S; Courtney, Theodore K

2009-10-01

The purpose of this study was to provide new insight into the etiology of primarily nonfatal, work-related electrical injuries. We developed a multistage, case-selection algorithm to identify electrical-related injuries from workers' compensation claims and a customized coding taxonomy to identify pre-injury circumstances. Workers' compensation claims routinely collected over a 1-year period from a large U.S. insurance provider were used to identify electrical-related injuries using an algorithm that evaluated: coded injury cause information, nature of injury, "accident" description, and injury description narratives. Concurrently, a customized coding taxonomy for these narratives was developed to abstract the activity, source, initiating process, mechanism, vector, and voltage. Among the 586,567 reported claims during 2002, electrical-related injuries accounted for 1283 (0.22%) of nonfatal claims and 15 fatalities (1.2% of electrical). Most (72.3%) were male, average age of 36, working in services (33.4%), manufacturing (24.7%), retail trade (17.3%), and construction (7.2%). Body part(s) injured most often were the hands, fingers, or wrist (34.9%); multiple body parts/systems (25.0%); lower/upper arm; elbow; shoulder, and upper extremities (19.2%). The leading activities were conducting manual tasks (55.1%); working with machinery, appliances, or equipment; working with electrical wire; and operating powered or nonpowered hand tools. Primary injury sources were appliances and office equipment (24.4%); wires, cables/cords (18.0%); machines and other equipment (11.8%); fixtures, bulbs, and switches (10.4%); and lightning (4.3%). No vector was identified in 85% of cases. and the work process was initiated by others in less than 1% of cases. Injury narratives provide valuable information to overcome some of the limitations of precoded data, more specially for identifying additional injury cases and in supplementing traditional epidemiologic data for further

Are organic consumers preferring or avoiding foods with nutrition and health claims?

DEFF Research Database (Denmark)

Aschemann-Witzel, Jessica; Maroschek, Nicole; Hamm, Ulrich

2013-01-01

consumer purchase motives in common. Organic food and functional food are, however, often described as contradictory rather than complementary in amongst others the concept of health. Functional food tends to be perceived as ‘unnatural’ by consumers. So far, it has not been researched how consumers react...... to a combination of both product concepts. A realistically designed purchase simulation was conducted with 210 organic consumers in Germany. Five organic products in three different categories were offered, unobtrusively altered so that they showed a nutrition, health or risk reduction claim on two products...

Sport-related concussions in New Zealand: a review of 10 years of Accident Compensation Corporation moderate to severe claims and costs.

Science.gov (United States)

King, Doug; Gissane, Conor; Brughelli, Matt; Hume, Patria A; Harawira, Joseph

2014-05-01

This paper provides an overview of the epidemiology of sport-related concussion and associated costs in New Zealand requiring medical treatment from 2001 to 2011 in seven sports codes. A retrospective review of injury entitlement claims by seven sports from 2001 to 2011. Data were analyzed by sporting code, age, ethnicity, gender and year of competition for total and moderate-to-severe (MSC) Accident Compensation Corporation (ACC) claims and costs. A total of 20,902 claims costing $NZD 16,546,026 were recorded over the study period of which 1330 (6.4%) were MSC claims. The mean yearly number and costs of MSC claims were 133 ± 36 and $1,303,942 ± 378,949. Rugby union had the highest number of MSC claims per year (38; 95% CI 36-41 per 1000 MSC claims). New Zealand Māori recorded the highest total ($6,000,759) and mean cost ($21,120) per MSC claim. Although MSC injury claims were only 6.4% of total claims, they accounted for 79.1% of total costs indicating that although the majority of sport-related concussions may be minor in severity, the related economic costs associated with more serious sport-related concussion can be high. The finding that rugby union recorded the most MSC claims in the current study was not unexpected. Of concern is that rugby league recorded a low number of MSC claims but the highest mean cost per claim. Due to the high mean cost per concussion, and the high total and mean cost for New Zealand Māori, further investigation is warranted. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Claim prevention at reactor facilities

International Nuclear Information System (INIS)

Colby, B.P.

1987-01-01

Why does a radiation worker bring a claim alleging bodily injury from radiation exposure? Natural cancer, fear of radiation induced cancer, financial gain, emotional distress and mental anguish are some reasons for workers' claims. In this paper the author describes what power reactor health physicists are doing to reduce the likelihood of claims by establishing programs which provide sound protection of workers, prevent radiological events, improve workers' knowledge of radiological conditions and provide guidance for radiological incident response

20 CFR 410.232 - Withdrawal of a claim.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Withdrawal of a claim. 410.232 Section 410.232 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969... Claims and Evidence § 410.232 Withdrawal of a claim. (a) Before adjudication of claim. A claimant (or an...

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

Energy Technology Data Exchange (ETDEWEB)

Breen, Micheal A.; Taylor, George A. [Boston Children' s Hospital, Department of Radiology, Boston, MA (United States); Dwyer, Kathy; Yu-Moe, Winnie [CRICO Risk Management Foundation, Boston, MA (United States)

2017-06-15

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

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

International Nuclear Information System (INIS)

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

2017-01-01

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

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

Science.gov (United States)

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

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of normal defecation during antibiotic treatment pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claim related to Lactobacillus rhamnosus GG and maintenance of normal defecation during antibiotic treatment. The food constituent, Lactobacillus rhamnosus GG, which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “help to maintain...... normal defecation during antibiotic treatment” and the target population proposed by the applicant is “healthy outpatient adults and children on oral antibiotic treatment”. Maintenance of normal defecation during antibiotic treatment is a beneficial physiological effect. The Panel notes...... human intervention studies, from which conclusions could be drawn for the scientific substantiation of the claim, did not show an effect of Lactobacillus rhamnosus GG on the incidence of diarrhoea resulting from antibiotic treatment. The Panel concludes that a cause and effect relationship has not been...

42 CFR 424.73 - Prohibition of assignment of claims by providers.

Science.gov (United States)

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Prohibition of assignment of claims by providers. 424.73 Section 424.73 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... and Reassignment of Claims § 424.73 Prohibition of assignment of claims by providers. (a) Basic...

Health branding ethics

DEFF Research Database (Denmark)

Anker, Thomas Boysen; Sandøe, Peter; Kamin, Tanja

2011-01-01

into account the ethical dimensions of health branding: this article presents a conceptual analysis of potential ethical problems in health branding. The analysis focuses on ethical concerns related to the application of three health brand elements (functional claims, process claims, and health symbols...

Characteristics of and risk factors for compensated occupational injury and disease claims in dairy farmers: a case-control study.

Science.gov (United States)

Karttunen, J P; Rautiainen, R H

2013-07-01

Research indicates that dairy farmers have an elevated risk of work-related adverse health outcomes. This case-control study evaluated the characteristics of and risk factors for compensated occupational injury and disease claims among Finnish dairy farmers. The cases consisted of 19 farm couples in which both spouses had a history of multiple claims. There were 283 claims in total, a rate of 26.6 claims per 100 person-years. The controls consisted of 12 couples in which neither spouse had compensated or rejected claims during their work history as insured farmers. A combined mail/telephone survey charted potential risk factors for compensated claims. These claims frequently involved work tasks and causes related to animal husbandry. Cattle were the most common cause for injuries in general and for serious injuries in particular. Gender differences in farm work and claims were observed. Using logistic regression analyses, we identified personal and work-related risk factors including long work history, small-scale dairy farm operation, and conventional stanchion barn for dairy cattle. Outdated working conditions, while not statistically significant, were positively associated with claims as well. Declined current work ability and musculoskeletal or respiratory conditions were significantly associated with claims where each of these outcomes may contribute to the other. Identified factors could be used to select subgroups of dairy farmers with either elevated or reduced risk of claims. Prevention of adverse health outcomes could be most effective when targeted to farmers at highest risk of occupational injury and disease.

Carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2018-01-01

Following an application from Specialised Nutrition Europe (SNE), submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver...... an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and contribute to the improvement of physical performance during a high‐intensity and long‐lasting physical exercise. The scope of the application was proposed to fall under a health claim based on newly developed...... effect. The claimed effect proposed by the applicant is ‘contribute to the improvement of physical performance during a high‐intensity and long‐lasting physical exercise’, which is considered by the Panel as a beneficial physiological effect. The Panel concludes that a cause and effect relationship has...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to iron and maintenance of normal hair growth pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

of a health claim based on newly developed scientific evidence related to iron and maintenance of normal hair growth. Iron is sufficiently characterised. The claimed effect is “reduction of excessive hair loss”. The target population proposed by the applicant is non-menopausal women, aged between 19 and 49...... years, presenting with excessive hair loss. The Panel considers that maintenance of normal hair growth is a beneficial physiological effect. The applicant identified a total of five observational studies and one review as pertinent to the claim. The narrative review contained no primary data. In two...... status and hair loss while a third study showed an association between low iron status and hair loss. In weighing the evidence, the Panel took into account that two observational studies showed no relationship of iron status with hair loss and that one observational study showed an association. The Panel...

Creatine in combination with resistance training and improvement in muscle strength: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

on the scientific substantiation of a health claim related to creatine in combination with resistance training and improvement in muscle strength. The Panel considers that the food constituent, creatine, which is the subject of the health claim, is sufficiently characterised. The Panel considers that improvement...... substantiation of the claim. In weighing the evidence the Panel took into account that, overall, the human intervention studies submitted provide evidence for an effect of creatine, consumed at doses of at least 3 g/day in combination with regular resistance training (three times per week for several weeks......) of moderate intensity, on muscle strength in adults over the age of 55, while no such effect was observed when similar doses of creatine on a weekly basis were given on training days only (three times per week). The Panel also took into account the plausible mechanism by which daily consumption of creatine...

Claims in civil engineering contracts

CERN Document Server

Speirs, N A

1999-01-01

This paper considers claims arising during civil engineering construction contracts. The meaning of the word 'claim' is considered and its possible implications for additional cost and time to completion. The conditions of the construction contract selected will influence the risk apportionment between contractor and client and the price offered by the contractor for the work. Competitive bidding constraints and profit margins in the construction industry, however, may also influence the price offered. This in turn can influence the likelihood of claims arising. The client from his point of view is concerned to complete the work within an agreed time and budget. The circumstances under which claims may arise are reviewed in relation to typical conditions of contract. These circumstances are then related to the CERN LHC civil works. Ways of avoiding claims, where this is possible, are considered. Finally, the means of evaluation of claims and their settlement are considered.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Monurelle® and reduction of bacterial colonisation of the urinary tract by the inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

on the scientific substantiation of a health claim related to Monurelle® and reduction of bacterial colonisation of the urinary tract by the inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells. The food that is the subject of the health claim, Monurelle®, which is a combination of 120 mg...... cranberry (Vaccinium macrocarpon) extract (including 36 mg proanthocyanidins) and 60 mg of ascorbic acid, is sufficiently characterised. The claimed effect proposed by the applicant is reduction of E.coli adhesion to uroepithelial cells. The Panel considers that reduction of bacterial colonisation...... of the urinary tract by inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells is a beneficial physiological effect. Several health claim applications on cranberry products standardised by their proanthocyanidin content have already been evaluated by EFSA with an unfavourable outcome. The Panel...

Scientific Opinion on the substantiation of a health claim related to fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

substantiation of a health claim related to fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and maintenance of lean body mass in the context...... of an energy-restricted diet. The Panel considers that the food that is the subject of the claim, fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims, is sufficiently characterised...... and effect relationship has not been established between the consumption of fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and maintenance of lean...

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

Science.gov (United States)

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

2017-10-05

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

Does the Valuation of Nutritional Claims Differ among Consumers? Insights from Spain

Science.gov (United States)

Jurado, Francesc; Gracia, Azucena

2017-01-01

The presence in the market of food products with nutritional claims is increasing. The objective of this paper is to assess consumers’ valuation of some nutritional claims (‘high in fiber’ and ‘reduced saturated fat’) in a European country and to test for differences among consumers. An artefactual non-hypothetical experiment was carried out in a realistic setting (mock/real brick-and-mortar supermarket) with a sample of 121 Spanish consumers stratified by gender, age, and body mass index. A latent class model was specified and estimated with the data from the experiment. Results indicate that consumers positively valued both nutritional claims, but the valuation was heterogeneous, and three consumer segments were detected. Two of them positively valued both nutritional claims (named ‘nutritional claim seekers’), while the third segment’s valuation was negative (named ‘nutritional claim avoiders’). This last segment is characterized by being younger males with university studies who give the least importance to health, natural ingredients, and the calorie/sugar/fat content when shopping. They pay less attention to nutritional information, and they stated that they use this information to a lesser extent. These consumers showed the least interest in healthy eating, and they reported that they do not have health problems related to their diet. PMID:28208811

Does the Valuation of Nutritional Claims Differ among Consumers? Insights from Spain

Directory of Open Access Journals (Sweden)

Francesc Jurado

2017-02-01

Full Text Available The presence in the market of food products with nutritional claims is increasing. The objective of this paper is to assess consumers’ valuation of some nutritional claims (‘high in fiber’ and ‘reduced saturated fat’ in a European country and to test for differences among consumers. An artefactual non-hypothetical experiment was carried out in a realistic setting (mock/real brick-and-mortar supermarket with a sample of 121 Spanish consumers stratified by gender, age, and body mass index. A latent class model was specified and estimated with the data from the experiment. Results indicate that consumers positively valued both nutritional claims, but the valuation was heterogeneous, and three consumer segments were detected. Two of them positively valued both nutritional claims (named ‘nutritional claim seekers’, while the third segment’s valuation was negative (named ‘nutritional claim avoiders’. This last segment is characterized by being younger males with university studies who give the least importance to health, natural ingredients, and the calorie/sugar/fat content when shopping. They pay less attention to nutritional information, and they stated that they use this information to a lesser extent. These consumers showed the least interest in healthy eating, and they reported that they do not have health problems related to their diet.

Administrative claims analysis of asthma-related health care utilization for patients who received inhaled corticosteroids with either montelukast or salmeterol as combination therapy.

Science.gov (United States)

Allen-Ramey, Felicia C; Bukstein, Don; Luskin, Allan; Sajjan, Shiva G; Markson, Leona E

2006-05-01

To compare asthma-related health care resource utilization among a matched cohort of asthma patients using inhaled corticosteroids (ICSs) plus either montelukast (MON) or salmeterol (SAL) as combination therapy for asthma, during a time prior to the availability of fixed-dose combinations of ICS/SAL. A retrospective analysis using the PHARMetrics patient-centric claims database was conducted for the period preceding the market introduction of combination fluticasone-SAL in September 2000. Patients had to meet the following criteria for inclusion in the study: they had to be between the ages of 4 and 55 years; they had to have been continuously enrolled for 2 years; they had to have initiated ICS/MON or ICS/SAL therapy between July 1, 1998, and June 30, 1999; and they had to have had either (a) a diagnosis of asthma (based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes of 493.xx) for 2 outpatient visits, 1 or more emergency department (ED) visits, or 1 or more hospitalizations within 1 year or (b) pharmacy claim records that contained a National Drug Code for an antiasthma medication (betaagonist, theophylline, ICS, cromolyn, or leukotriene) 2 or more times within 1 year. ICS/MON and ICS/SAL patients were matched 1 to 1 on age and propensity score. Outcomes included asthma-related hopitalizations and ED visits with ICD-9-CM codes of 493.xx, and oral corticosteroid (OCS) fills and short-acting beta-agonist (SABA) fills. Multivariate regression analyses were performed. Subgroup analyses based on sequential or concurrent initiation of combination therapy were also conducted. A total of 1,216 patients were matched (ICS/MON = 608; ICS/SAL= 608). Decreased odds of ED visits and/or hospitalizations were observed with ICS/MON (adjusted odds ratio [OR] = 0.58; 95% confidence interval [CI], 0.35- 0.98) versus ICS/SAL. The odds of postindex OCS fills were not different for ICS/MON and ICS/SAL patients (adjusted OR = 1.04; 95

Consumer understanding of sugars claims on food and drink products.

Science.gov (United States)

Patterson, N J; Sadler, M J; Cooper, J M

2012-06-01

Consumer understanding of nutrition and health claims is a key aspect of current regulations in the European Union (EU). In view of this, qualitative and quantitative research techniques were used to investigate consumer awareness and understanding of product claims in the UK, focusing particularly on nutrition claims relating to sugars. Both research methods identified a good awareness of product claims. No added sugars claims were generally preferred to reduced sugars claims, and there was a general assumption that sweeteners and other ingredients would be added in place of sugars. However, there was little awareness of the level of sugar reduction and the associated calorie reduction in products when reduced sugars claims were made on pack. In focus groups, participants felt deceived if sugar reduction claims were being made without a significant reduction in calories. This was reinforced in the quantitative research which showed that respondents expected a similar and meaningful level of calorie reduction to the level of sugar reduction. The research also identified consumer confusion around the calorie content of different nutrients, including over-estimation of the calorie content of sugars. This is crucial to consumers' expectations as they clearly link sugar to calories and therefore expect a reduction in sugar content to deliver a reduction in calorie content.

Consumer and product-specific characteristics influencing the effect of nutrition, health and risk reduction claims on preferences and purchase behavior - A systematic review.

Science.gov (United States)

Steinhauser, Johann; Hamm, Ulrich

2018-08-01

The research on nutrition, health, and risk reduction claims (NHR claims) shows a lack of consensus as to whether these claims have a positive or negative effect on consumer's preferences and purchase behavior. This issue has been highlighted by many authors. Therefore, a comprehensive literature review was performed to find reasons for contradictory results. First, a theoretical framework was developed which divided the determinants of the effects of NHR claims on consumers' preferences and purchase behavior into consumer and product-specific characteristics. Additionally, a categorization for the different NHR claim types was constructed to make the studies comparable. Afterwards, the scientific literature from the 1980s until May 2017 was scanned and 66 articles were found to be relevant. Consumer-specific characteristics such as nutrition knowledge, health motivation, familiarity, and socio-demographic characteristics were found to influence the NHR claim effect. Important product-specific characteristics were the perceived healthiness of the food product, the interaction between the product and the nutrient in the NHR claim, and the interaction between the claimed benefit and the NHR claim type. The consumer's nutrition knowledge and the product's perceived healthiness were deemed to be the most promising determinants for further investigation. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Biocodex, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related...... to citrulline-malate and faster recovery from muscle fatigue after exercise. Citrulline-malate is sufficiently characterised. The claimed effect is “maintenance of ATP levels through reduction of lactates in excess for an improved recovery from muscle fatigue”. The target population proposed by the applicant...... is healthy children above six years of age and adults. The Panel considers that faster recovery from muscle fatigue after exercise contributing to the restoration of muscle function is a beneficial physiological effect. A total of 33 references were considered as pertinent to the claim by the applicant...

Medicare Part D Claims Data

Data.gov (United States)

U.S. Department of Health & Human Services — This page contains information on Part D claims data for the purposes of research, analysis, reporting, and public health functions. These data will also be used to...

Chronic disease risk factors, healthy days and medical claims in South African employees presenting for health risk screening

Directory of Open Access Journals (Sweden)

Kolbe-Alexander Tracy L

2008-07-01

Full Text Available Abstract Background Non-communicable diseases (NCD accounts for more than a third (37% of all deaths in South Africa. However, this burden of disease can be reduced by addressing risk factors. The aim of this study was to determine the health and risk profile of South African employees presenting for health risk assessments and to measure their readiness to change and improve lifestyle behaviour. Methods Employees (n = 1954 from 18 companies were invited to take part in a wellness day, which included a health-risk assessment. Self-reported health behaviour and health status was recorded. Clinical measures included cholesterol finger-prick test, blood pressure and Body Mass Index (BMI. Health-related age was calculated using an algorithm incorporating the relative risk for all case mortality associated with smoking, physical activity, fruit and vegetable intake, BMI and cholesterol. Medical claims data were obtained from the health insurer. Results The mean percentage of participation was 26% (n = 1954 and ranged from 4% in transport to 81% in the consulting sector. Health-related age (38.5 ± 12.9 years was significantly higher than chronological age (34.9 ± 10.3 yrs (p Conclusion SA employees' health and lifestyle habits are placing them at increased risk for NCD's, suggesting that they may develop NCD's earlier than expected. Inter-sectoral differences for health-related age might provide insight into those companies which have the greatest need for interventions, and may also assist in predicting future medical expenditure. This study underscores the importance of determining the health and risk status of employees which could assist in identifying the appropriate interventions to reduce the risk of NCD's among employees.

21 CFR 101.76 - Health claims: fiber-containing grain products, fruits, and vegetables and cancer.

Science.gov (United States)

2010-04-01

... obesity, alcohol consumption, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and..., overweight and obesity, alcohol consumption, ultraviolet or ionizing radiation, exposure to cancer causing... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Health claims: fiber-containing grain products...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to “Lactobacillus plantarum TENSIA® in the semi-hard Edam-type „heart cheese‟ of Harmony™” and maintenance of normal blood pressure pursuant to Article

DEFF Research Database (Denmark)

Tetens, Inge

on the scientific substantiation of a health claim related to “Lactobacillus plantarum TENSIA® in the semi-hard Edam-type “heart cheese” of Harmony™” and maintenance of normal blood pressure (BP). The food constituent L. plantarum TENSIA®, which is the subject of the health claim, is sufficiently characterised...... exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum TENSIA®in the semi-hard Edam-type “heart cheese” of Harmony™ and maintenance of normal blood pressure........ The Panel considers that the maintenance of normal blood pressure is a beneficial physiological effect. The applicant provided 47 references which did not address the effects of L. plantarum TENSIA® on BP. The Panel considers that no conclusions can be drawn from these references for the scientific...

20 CFR 410.705 - Duplicate claims.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Duplicate claims. 410.705 Section 410.705 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Rules for the Review of Denied and Pending Claims Under the Black Lung...

Rehabilitation Utilization following a Work-Related Traumatic Brain Injury: A Sex-Based Examination of Workers' Compensation Claims in Victoria, Australia.

Directory of Open Access Journals (Sweden)

E Niki Guerriero

Full Text Available To report on and examine differences in the use of four types of rehabilitation services (occupational therapy, physiotherapy, psychology, and speech therapy by men and women following a work-related traumatic brain injury in Victoria, Australia; and to examine the importance of demographic, need, work-related and geographic factors in explaining these differences.A retrospective cohort design was used to analyze 1786 work-related traumatic brain injury workers' compensation claims lodged between 2004 and 2012 in Victoria, Australia. ZINB regressions were conducted for each type of rehabilitation service to examine the relationship between sex and rehabilitation use. Covariates included demographic, need-related, work-related, and geographic factors.Out of all claims (63% male, 37% female, 13% used occupational therapy, 23% used physiotherapy, 9% used psychology, and 2% used speech therapy at least once during the first year of service utilization. After controlling for demographic, need-related, work-related, and geographic factors, women were more likely to use physiotherapy compared to men. Men and women were equally likely to use occupational therapy and psychology services. The number of visits in the first year for each type of service did not differ between male and female users.Our findings support a sex-based approach to studying rehabilitation utilization in work-related populations. Future research is needed to examine other factors associated with rehabilitation utilization and to determine the implications of different rehabilitation utilization patterns on health and return-to-work outcomes.

Scientific Opinion on the substantiation of a health claim related to an equimolar mixture of the CLA isomers c9,t11 and t10,c12 (marketed as Clarinol® and Tonalin®) and “contributes to a reduction in body fat mass” pursuant to Article 13(5) of Regulation

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following an application from BASF SE and Stepan Lipid Nutrition, submitted for the authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...... to deliver an opinion on the scientific substantiation of a health claim related to an equimolar mixture (marketed under the trade names Clarinol® and Tonalin®) of the two conjugated linoleic acid (CLA) isomers c9,t11 and t10,c12. The Panel considers that the food is sufficiently characterised. The claimed...... of the CLA isomers c9,t11 and t10,c12, marketed under the trade names of Clarinol® and Tonalin®, and a beneficial physiological effect....

Work ability, effort-reward imbalance and disability pension claims.

Science.gov (United States)

Wienert, J; Spanier, K; Radoschewski, F M; Bethge, M

2017-12-30

Effort-reward imbalance (ERI) and self-rated work ability are known independent correlates and predictors of intended disability pension claims. However, little research has focused on the interrelationship between the three and whether self-rated work ability mediates the relationship between ERI and intended disability pension claims. To investigate whether self-rated work ability mediates the association between ERI and intended disability pension claims. Baseline data from participants of the Third German Sociomedical Panel of Employees, a 5-year cohort study that investigates determinants of work ability, rehabilitation utilization and disability pensions in employees who have previously received sickness benefits, were analysed. We tested direct associations between ERI with intended disability pension claims (Model 1) and self-rated work ability (Model 2). Additionally, we tested whether work ability mediates the association between ERI and intended disability pension claims (Model 3). There were 2585 participants. Model 1 indicated a significant association between ERI and intended disability pension claims. Model 2 showed a significant association between ERI and self-rated work ability. The mediation in Model 3 revealed a significant indirect association between ERI and intended disability pension claims via self-rated work ability. There was no significant direct association between ERI and intended disability pension claims. Our results support the adverse health-related impact of ERI on self-rated work ability and intended disability pension claims. © The Author 2017. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

Science.gov (United States)

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B

2018-03-01

The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to AlphaGOS® and a reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch) which should replace sugars in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent, non-digestible carbohydrates, which...... is the subject of the health claim, and the food constituent (i.e. sugars) that non-digestible carbohydrates should replace in foods or beverages are both sufficiently characterised in relation to the claimed effect. The Panel considers that a reduction of post-prandial glycaemic responses might be a beneficial...... concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates and a reduction of post-prandial glycaemic responses as compared with sugar-containing foods/beverages....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to KF2BL20 and maintenance of normal hair pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

and contributes to reduce hair loss”. The target population proposed by the applicant is healthy adults in the general population. The Panel considers that maintenance of normal hair is a beneficial physiological effect. The applicant identified one single arm study as being pertinent to the health claim...... related to KF2BL20, which is a combination of keratin, copper, zinc, niacin, pantothenic acid, pyridoxine and D-biotin, and maintenance of normal hair. The Panel considers that KF2BL20 is sufficiently characterised. The claimed effect is “helps to reinforce hair strength and normal hair function....... The Panel notes that this study was uncontrolled and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of KF2BL20 and maintenance of normal hair....

Claims-based definition of death in Japanese claims database: validity and implications.

Science.gov (United States)

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

2013-01-01

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. 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. 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.

Analysis of the evidence-practice gap to facilitate proper medical care for the elderly: investigation, using databases, of utilization measures for National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB).

Science.gov (United States)

Nakayama, Takeo; Imanaka, Yuichi; Okuno, Yasushi; Kato, Genta; Kuroda, Tomohiro; Goto, Rei; Tanaka, Shiro; Tamura, Hiroshi; Fukuhara, Shunichi; Fukuma, Shingo; Muto, Manabu; Yanagita, Motoko; Yamamoto, Yosuke

2017-06-06

As Japan becomes a super-aging society, presentation of the best ways to provide medical care for the elderly, and the direction of that care, are important national issues. Elderly people have multi-morbidity with numerous medical conditions and use many medical resources for complex treatment patterns. This increases the likelihood of inappropriate medical practices and an evidence-practice gap. The present study aimed to: derive findings that are applicable to policy from an elucidation of the actual state of medical care for the elderly; establish a foundation for the utilization of National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), and present measures for the utilization of existing databases in parallel with NDB validation.Cross-sectional and retrospective cohort studies were conducted using the NDB built by the Ministry of Health, Labor and Welfare of Japan, private health insurance claims databases, and the Kyoto University Hospital database (including related hospitals). Medical practices (drug prescription, interventional procedures, testing) related to four issues-potential inappropriate medication, cancer therapy, chronic kidney disease treatment, and end-of-life care-will be described. The relationships between these issues and clinical outcomes (death, initiation of dialysis and other adverse events) will be evaluated, if possible.

Age related distributive justice and claims on resources.

Science.gov (United States)

Irwin, S

1996-03-01

The ageing population structure, and claims on resources by non-working groups, are seen by many to be contributing to a growing welfare crisis. In their arguments, relations between age groups and generations will become increasingly fraught, and welfare arrangements will be undermined, as 'unacceptable' levels of taxation blight the experience of a contracting workforce, required to resource a growing welfare population. However, more seems to be known about researchers' views on distributive justice than is known about the perceptions of their subject populations. It has not been demonstrated that members of age groups share interests which are consonant with their cohort experience, or perceive their interests to be in conflict with those members of other age groups or generations. This paper analyses empirical evidence on people's perceptions of who should get, and do, what, in developing an argument that standard processes do not place age groups or generations in antagonistic relationship. Understanding the relations between age groups and generations is essential to explaining change in patterns of inequality, but the interdependence of these relations suggest that they are part of a coherent social structure, and not likely to give rise to crisis in the ways predicted.

32 CFR 536.19 - Disaster claims planning.

Science.gov (United States)

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Disaster claims planning. 536.19 Section 536.19... AGAINST THE UNITED STATES The Army Claims System § 536.19 Disaster claims planning. All ACOs will prepare... requirements related to disaster claims planning. ...

Claims procedures for employee benefit plans--Pension and Welfare Benefits Administration, Department of Labor. Request for information.

Science.gov (United States)

1997-09-08

This document requests information from the public concerning the advisability of amending the existing regulation under the Employee Retirement Income Security Act of 1974 (ERISA) that establishes minimum requirements for employee benefit plan claims procedures. The term "claims procedure" refers to the process that employee benefit plans must provide for participants and beneficiaries who seek to obtain pension or welfare plan benefits, including requests for medical treatment or services, consideration of claims, and review of denials of claims by plans. The primary purpose of this notice is to obtain information to assist the Department of Labor (the Department) in evaluating (1) the extent to which the current claims procedure regulation assures that group health plan participants and beneficiaries are provided with effective and timely means to file and resolve claims for health care benefits, and (1) whether and in what way the existing minimum requirements should be amended with respect to group health plans covered by ERISA. The furnished information also will assist the Department in determining whether the regulation should be amended with respect to pension plans covered by ERISA and in developing legislative proposals to address any identified deficiencies relating to the claims procedures that cannot be addressed by amending the current regulation.

Operating room fires: a closed claims analysis.

Science.gov (United States)

Mehta, Sonya P; Bhananker, Sanjay M; Posner, Karen L; Domino, Karen B

2013-05-01

To assess patterns of injury and liability associated with operating room (OR) fires, closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1985 were reviewed. All claims related to fires in the OR were compared with nonfire-related surgical anesthesia claims. An analysis of fire-related claims was performed to identify causative factors. There were 103 OR fire claims (1.9% of 5,297 surgical claims). Electrocautery was the ignition source in 90% of fire claims. OR fire claims more frequently involved older outpatients compared with other surgical anesthesia claims (P fire claims (P fires (n = 93) increased over time (P fires occurred during head, neck, or upper chest procedures (high-fire-risk procedures). Oxygen served as the oxidizer in 95% of electrocautery-induced OR fires (84% with open delivery system). Most electrocautery-induced fires (n = 75, 81%) occurred during monitored anesthesia care. Oxygen was administered via an open delivery system in all high-risk procedures during monitored anesthesia care. In contrast, alcohol-containing prep solutions and volatile compounds were present in only 15% of OR fires during monitored anesthesia care. Electrocautery-induced fires during monitored anesthesia care were the most common cause of OR fires claims. Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the critical role of supplemental oxygen by an open delivery system during use of the electrocautery, is crucial to prevent OR fires. Continuing education and communication among OR personnel along with fire prevention protocols in high-fire-risk procedures may reduce the occurrence of OR fires.

Exploring Health System Responsiveness in Ambulatory Care and Disease Management and its Relation to Other Dimensions of Health System Performance (RAC) - Study Design and Methodology.

Science.gov (United States)

Röttger, Julia; Blümel, Miriam; Engel, Susanne; Grenz-Farenholtz, Brigitte; Fuchs, Sabine; Linder, Roland; Verheyen, Frank; Busse, Reinhard

2015-05-20

The responsiveness of a health system is considered to be an intrinsic goal of health systems and an essential aspect in performance assessment. Numerous studies have analysed health system responsiveness and related concepts, especially across different countries and health systems. However, fewer studies have applied the concept for the evaluation of specific healthcare delivery structures and thoroughly analysed its determinants within one country. The aims of this study are to assess the level of perceived health system responsiveness to patients with chronic diseases in ambulatory care in Germany and to analyse the determinants of health system responsiveness as well as its distribution across different population groups. The target population consists of chronically ill people in Germany, with a focus on patients suffering from type 2 diabetes and/or from coronary heart disease (CHD). Data comes from two different sources: (i) cross-sectional survey data from a postal survey and (ii) claims data from a German sickness fund. Data from both sources will be linked at an individual-level. The postal survey has the purpose of measuring perceived health system responsiveness, health related quality of life, experiences with disease management programmes (DMPs) and (subjective) socioeconomic background. The claims data consists of information on (co)morbidities, service utilization, enrolment within a DMP and sociodemographic characteristics, including the type of residential area. RAC is one of the first projects linking survey data on health system responsiveness at individual level with claims data. With this unique database, it will be possible to comprehensively analyse determinants of health system responsiveness and its relation to other aspects of health system performance assessment. The results of the project will allow German health system decision-makers to assess the performance of nonclinical aspects of healthcare delivery and their determinants in two

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Wheat Polar Lipid Extract and protection of the skin against dehydration pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Extraction Purification Innovation France, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to Wheat Polar Lipid Extract and protection of the skin against dehydration. The Panel considers that Wheat Polar Lipid Extract is sufficiently characterised. The claimed effect is “contributes to improve skin hydration”. The target population proposed by the applicant...... can be drawn from one uncontrolled pilot study, nor from one study which was not carried out with the food which is the subject of the claim. In weighing the evidence, the Panel took into account that one human intervention study reported an effect of consumption of Wheat Polar Lipid Extract...

Using Self-reports or Claims to Assess Disease Prevalence: It's Complicated.

Science.gov (United States)

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.

Impact of a Comprehensive Workplace Hand Hygiene Program on Employer Health Care Insurance Claims and Costs, Absenteeism, and Employee Perceptions and Practices.

Science.gov (United States)

Arbogast, James W; Moore-Schiltz, Laura; Jarvis, William R; Harpster-Hagen, Amanda; Hughes, Jillian; Parker, Albert

2016-06-01

The aim of this study was to determine the efficacy of a multimodal hand hygiene intervention program in reducing health care insurance claims for hygiene preventable infections (eg, cold and influenza), absenteeism, and subjective impact on employees. A 13.5-month prospective, randomized cluster controlled trial was executed with alcohol-based hand sanitizer in strategic workplace locations and personal use (intervention group) and brief hand hygiene education (both groups). Four years of retrospective data were collected for all participants. Hygiene-preventable health care claims were significantly reduced in the intervention group by over 20% (P Employee survey data showed significant improvements in hand hygiene behavior and perception of company concern for employee well-being. Providing a comprehensive, targeted, yet simple to execute hand hygiene program significantly reduced the incidence of health care claims and increased employee workplace satisfaction.

Scientific Opinion on the substantiation of a health claim related to “L-tug lycopene” and reduction of blood LDL-cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

claim related to “L-tug lycopene” and reduction of blood low-density lipoprotein (LDL)-cholesterol. The food constituent that is the subject of the claim is L-tug lycopene (i.e. Lyc-O-Mato® embedded in fat-rich matrices by a manufacturing process claimed as proprietary and confidential by the applicant......). The Panel considers that the food constituent, L-tug lycopene, which is the subject of the claim, is sufficiently characterised. The Panel considers that reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces...... the risk of CHD. The Panel notes that the unpublished studies submitted to support the claim were exploratory in nature and insufficient information was provided to allow the scientific evaluation of these studies. The Panel concludes that a cause and effect relationship has not been established between...

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

Science.gov (United States)

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

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to Nutriose®06 and a reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

-prandial glycaemia. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch), which should replace glycaemic carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent, non......-digestible carbohydrates, which is the subject of the health claim, and the food constituent (i.e. glycaemic carbohydrates) that non-digestible carbohydrates should replace in foods or beverages are both sufficiently characterised in relation to the claimed effect. The Panel considers that a reduction of post...... applies to this application. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates and a reduction of post-prandial glycaemic responses as compared with foods/beverages containing glycaemic...

Power in global health agenda-setting: the role of private funding Comment on "Knowledge, moral claims and the exercise of power in global health".

Science.gov (United States)

Levine, Ruth E

2015-03-04

The editorial by Jeremy Shiffman, "Knowledge, moral claims and the exercise of power in global health", highlights the influence on global health priority-setting of individuals and organizations that do not have a formal political mandate. This sheds light on the way key functions in global health depend on private funding, particularly from the Bill & Melinda Gates Foundation. © 2015 by Kerman University of Medical Sciences.

Are sensory attributes and acceptance influenced by nutritional and health claims of low-sodium salami? Preliminary study with Brazilian consumers

Directory of Open Access Journals (Sweden)

Marcio Aurélio de Almeida

2017-01-01

Full Text Available The first contact between consumers and the food product is usually the packaging and it’s labelling. Therefore, it is the primary means to generate consumer’s expectations. The aim of the present work was to evaluate the influence of nutritional and health claims on acceptance of salami with reduced sodium content, aimed at finding guidance for the product reformulation. Sixt y consumers evaluated four samples of salami. The overall acceptance was evaluated using a nine - point hedonic scale, and the attributes color, tenderness, characteristic flavor and salt content, were evaluated by 7 – point just - about - right (JAR scale. For the expectation test, overall liking of salami with reduced sodium content was evaluated by consumers under three conditions : (1 blind test (B; (2 expectation generated by nutritional and health claims (E, and (3 consumers re - tasted the salami having the nutrition and health claims available (R. Student’s t - tests performed on data indicated no significant differences (p > 0.05 between the mean acceptance under the blind (B and real (R conditions, although expectation ratings (E were significantly higher than (B (p ≤ 0.05. However, linear regression of (R - B x (E - B ratings revealed a major assimilation effect of expectation, especially under negative disconfirmation (E > B. Contrast effect was also observed, but to a lesser extent . The results showed that saltiness attribute was not decisive in decreased acceptance according to the JAR scale, but it was relevant in the aftertaste generated by adding salt substitutes. Finally, nutritional and health claims had little effect on consumer ac ceptance.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2014 . Scientific Opinion on the substantiation of a health claim related to a standardised aqueo us extract from white kidney bean ( Phaseolus vulgaris L.) and reduction of body weight pursuant to Article 13

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

an opinion on the scientific substantiation of a health claim related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect...... for a mechanism by which the standardised aqueous extract from white kidney bean could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of the standardised aqueous extract from white kidney bean (Phaseolus...... vulgaris L.) and reduction of body weight....

77 FR 22204 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

Science.gov (United States)

2012-04-13

... relationship between the national government and the States, or on the distribution of power and... relationship between the Federal government and Indian tribes, or on the distribution of power and... claim for personal injury, including pain and suffering, the claimant is required to submit the...

Nutrition issues in Codex: health claims, nutrient reference values and WTO agreements: a conference report.

Science.gov (United States)

Aggett, Peter J; Hathcock, John; Jukes, David; Richardson, David P; Calder, Philip C; Bischoff-Ferrari, Heike; Nicklas, Theresa; Mühlebach, Stefan; Kwon, Oran; Lewis, Janine; Lugard, Maurits J F; Prock, Peter

2012-03-01

Codex documents may be used as educational and consensus materials for member governments. Also, the WTO SPS Agreement recognizes Codex as the presumptive international authority on food issues. Nutrient bioavailability is a critical factor in determining the ability of nutrients to provide beneficial effects. Bioavailability also influences the quantitative dietary requirements that are the basis of nutrient intake recommendations and NRVs. Codex, EFSA and some national regulatory authorities have established guidelines or regulations that will permit several types of health claims. The scientific basis for claims has been established by the US FDA and EFSA, but not yet by Codex. Evidence-based nutrition differs from evidence-based medicine, but the differences are only recently gaining recognition. Health claims on foods may provide useful information to consumers, but many will interpret the information to mean that they can rely upon the food or nutrient to eliminate a disease risk. NRVs are designed to provide a quantitative basis for comparing the nutritive values of foods, helping to illustrate how specific foods fit into the overall diet. The INL-98 and the mean of adult male and female values provide NRVs that are sufficient when used as targets for individual intakes by most adults. WTO recognizes Codex as the primary international authority on food issues. Current regulatory schemes based on recommended dietary allowances are trade restrictive. A substantial number of decisions by the EFSA could lead to violation of WTO agreements.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to barley soup “Orzotto” and protection of blood lipids from oxidative damage pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

on the scientific substantiation of a health claim related to barley soup “Orzotto” and protection of blood lipids from oxidative damage. The Panel considers that barley soup “Orzotto”, which is a vegetable mix containing pearled barley, Tuscan Black cabbage, potatoes, “blu savoy” cabbage, purple carrots, “bi...... for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of barley soup “Orzotto” and protection of blood lipids from oxidative damage....

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to intense sweeteners and contribution to the maintenance or achievement of a normal body weight (ID 1136, 1444, 4299), reduction of post-prandial glycaemic responses (ID 4298), maintenance of normal blood glucose concentrations (ID 1221, 4298), and maintenance of tooth mineralisation by decreasing tooth demineralisation (ID 1134, 1167, 1283) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health cla...... sweeteners, which should replace sugars in foods and beverages in order to obtain the claimed effects. The Panel considers that intense sweeteners are sufficiently characterised in relation to the claimed effects........ The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituents that are the subject of the health claims are intense...

Predicting number of hospitalization days based on health insurance claims data using bagged regression trees.

Science.gov (United States)

Xie, Yang; Schreier, Günter; Chang, David C W; Neubauer, Sandra; Redmond, Stephen J; Lovell, Nigel H

2014-01-01

Healthcare administrators worldwide are striving to both lower the cost of care whilst improving the quality of care given. Therefore, better clinical and administrative decision making is needed to improve these issues. Anticipating outcomes such as number of hospitalization days could contribute to addressing this problem. In this paper, a method was developed, using large-scale health insurance claims data, to predict the number of hospitalization days in a population. We utilized a regression decision tree algorithm, along with insurance claim data from 300,000 individuals over three years, to provide predictions of number of days in hospital in the third year, based on medical admissions and claims data from the first two years. Our method performs well in the general population. For the population aged 65 years and over, the predictive model significantly improves predictions over a baseline method (predicting a constant number of days for each patient), and achieved a specificity of 70.20% and sensitivity of 75.69% in classifying these subjects into two categories of 'no hospitalization' and 'at least one day in hospital'.

Incidence of workers compensation indemnity claims across socio-demographic and job characteristics.

Science.gov (United States)

Du, Juan; Leigh, J Paul

2011-10-01

We hypothesized that low socioeconomic status, employer-provided health insurance, low wages, and overtime were predictors of reporting workers compensation indemnity claims. We also tested for gender and race disparities. Responses from 17,190 (person-years) Americans participating in the Panel Study of Income Dynamics, 1997-2005, were analyzed with logistic regressions. The dependent variable indicated whether the subject collected benefits from a claim. Odds ratios for men and African-Americans were relatively large and strongly significant predictors of claims; significance for Hispanics was moderate and confounded by education. Odds ratios for variables measuring education were the largest for all statistically significant covariates. Neither low wages nor employer-provided health insurance was a consistent predictor. Due to confounding from the "not salaried" variable, overtime was not a consistently significant predictor. Few studies use nationally representative longitudinal data to consider which demographic and job characteristics predict reporting workers compensation indemnity cases. This study did and tested some common hypotheses about predictors. Copyright © 2011 Wiley-Liss, Inc.

77 FR 22236 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

Science.gov (United States)

2012-04-13

... between the national government and the States, or on the distribution of power and responsibilities among... relationship between the Federal government and Indian tribes, or on the distribution of power and... claim for personal injury, including pain and suffering, the claimant is required to submit the...

Health and Nutrient Content Claims in Food Advertisements on Hispanic and Mainstream Prime-Time Television

Science.gov (United States)

Abbatangelo-Gray, Jodie; Byrd-Bredbenner, Carol; Austin, S. Bryn

2008-01-01

Objective: Characterize frequency and type of health and nutrient content claims in prime-time weeknight Spanish- and English-language television advertisements from programs shown in 2003 with a high viewership by women aged 18 to 35 years. Design: Comparative content analysis design was used to analyze 95 hours of Spanish-language and 72 hours…

32 CFR 536.120 - Claims payable as maritime claims.

Science.gov (United States)

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...

Bridging international law and rights-based litigation: mapping health-related rights through the development of the Global Health and Human Rights Database.

Science.gov (United States)

Meier, Benjamin Mason; Cabrera, Oscar A; Ayala, Ana; Gostin, Lawrence O

2012-06-15

The O'Neill Institute for National and Global Health Law at Georgetown University, the World Health Organization, and the Lawyers Collective have come together to develop a searchable Global Health and Human Rights Database that maps the intersection of health and human rights in judgments, international and regional instruments, and national constitutions. Where states long remained unaccountable for violations of health-related human rights, litigation has arisen as a central mechanism in an expanding movement to create rights-based accountability. Facilitated by the incorporation of international human rights standards in national law, this judicial enforcement has supported the implementation of rights-based claims, giving meaning to states' longstanding obligations to realize the highest attainable standard of health. Yet despite these advancements, there has been insufficient awareness of the international and domestic legal instruments enshrining health-related rights and little understanding of the scope and content of litigation upholding these rights. As this accountability movement evolves, the Global Health and Human Rights Database seeks to chart this burgeoning landscape of international instruments, national constitutions, and judgments for health-related rights. Employing international legal research to document and catalogue these three interconnected aspects of human rights for the public's health, the Database's categorization by human rights, health topics, and regional scope provides a comprehensive means of understanding health and human rights law. Through these categorizations, the Global Health and Human Rights Database serves as a basis for analogous legal reasoning across states to serve as precedents for future cases, for comparative legal analysis of similar health claims in different country contexts, and for empirical research to clarify the impact of human rights judgments on public health outcomes. Copyright © 2012 Meier, Nygren

Status of medical liability claims in Saudi Arabia

International Nuclear Information System (INIS)

Samarkandi, A.

2006-01-01

With the evolution of health services in Saudi Arabia, there has been increase in the number of medical practice litigations. The author analyzed the medical malpractice litigation that was referred to the National Medico-Legal Committee (MLC) in order to evaluate the magnitude and underlying factors of the problem in Saudi Arabia. A retrospective analysis of the official records of Medico-Legal malpractice over the period 1420H-1424H (199-2003) was performed. The incidence among different medical specialties, location, and final resolution of each claim were identified. Data analysis revealed an increasing trend in the total number of claims over the study period, with a sharp increase in the transition between 1422H and 1423H (2001-200). The distribution of claims over different medical specialties showed that obstetrical practice took the lead with 27%, followed by general surgery and subspecialties, represented by 17% each, internal medicine 13%, while pediatrics contributed 10% of claims: the fewest claims were in dentistry with 2.5%. The majority of claims were referred to the Ministry of Health and private sectors medical facilities. Most claims were from the Riyadh region over the period between 1420H to 1422H (1999-2001), while thereafter, during 1423 and 1424H (2002 and 2003), the Holy Capital had the highest number of claims referred to the MLC. Adherence to standards of medical practice is by far the best approach to avoid or reduce the incidence of litigation. (author)

Clinical negligence claims in pediatric surgery in England: pattern and trends.

Science.gov (United States)

Thyoka, Mandela

2015-02-01

We hypothesized that there has been an increase in the number of successful litigation claims in pediatric surgery in England. Our aim was to report the incidence, causes, and costs of clinical negligence claims against the National Health Service (NHS) in relation to pediatric surgery. We queried the NHS Litigation Authority (NHSLA) on litigation claims among children undergoing pediatric surgery in England (2004-2012). We decided a priori to only examine closed cases (decision and payment made). Data included year of claim, year of payment of claim, payment per claim, paid-to-closed ratio, and severity of outcome of clinical incident. Out of 112 clinical negligence claims in pediatric surgery, 93 (83%) were finalized-73 (65%) were settled and damages paid to the claimant and 20 (18%) were closed with no payment, and 19 (17%) remain open. The median payment was £13,537 (600-500,000) and median total cost borne by NHSLA was £31,445 (600-730,202). Claims were lodged at a median interval of 2 (0-13) years from time of occurrence with 55 (75%) cases being settled within the 3 years of being received. The commonest reasons for claims were postoperative complications (n=20, 28%), delayed treatment (n=16, 22%), and/or diagnosis (n=14, 19%). Out of 73, 17 (23%) closed claims resulted in case fatality. Conclusion: Two-thirds of all claims in pediatric surgery resulted in payment to claimant, and the commonest reasons for claims were postoperative complications, delayed treatment, and/or diagnosis. Nearly a quarter of successful claims were in cases where negligence resulted in case fatality. Pediatric surgeons should be aware of common diagnostic and treatment shortfalls as high-risk areas of increased susceptibility to clinical negligence claims. Georg Thieme Verlag KG Stuttgart · New York.

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

Science.gov (United States)

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

2017-04-01

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

Consumer attitudes and understanding of cholesterol-lowering claims on food: randomize mock-package experiments with plant sterol and oat fibre claims.

Science.gov (United States)

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 (Pprofile. 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.

The Role of Documentation Quality in Anesthesia-Related Closed Claims: A Descriptive Qualitative Study.

Science.gov (United States)

Wilbanks, Bryan A; Geisz-Everson, Marjorie; Boust, Rebecca R

2016-09-01

Clinical documentation is a critical tool in supporting care provided to patients. Sound documentation provides a picture of clinical events that can be used to improve patient care. However, many other uses for clinical documentation are equally important. Such documentation informs clinical decision support tools, creates a legal record of patient care, assists in financial reimbursement of services, and serves as a repository for secondary data analysis. Conversely, poor documentation can impair patient safety and increase malpractice risk exposure by reflecting poor or inaccurate information that ultimately may guide patient care decisions.Through an examination of anesthesia-related closed claims, a descriptive qualitative study emerged, which explored the antecedents and consequences of documentation quality in the claims reviewed. A secondary data analysis utilized a database generated by the American Association of Nurse Anesthetists Foundation closed claim review team. Four major themes emerged from the analysis. Themes 1, 2, and 4 primarily describe how poor documentation quality can have negative consequences for clinicians. The third theme primarily describes how poor documentation quality that can negatively affect patient safety.

Center for Medicare & Medicaid Services (CMS) , Medicare Claims data

Data.gov (United States)

U.S. Department of Health & Human Services — 2003 forward. CMS compiles claims data for Medicare and Medicaid patients across a variety of categories and years. This includes Inpatient and Outpatient claims,...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to flaxseed oil and vitamin E and maintenance of the skin permeability barrier function pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

related to a combination of flaxseed oil and vitamin E and maintenance of the skin permeability barrier function. The food constituent that is the subject of the health claim is a combination of flaxseed oil and vitamin E. The Panel considers that the combination of flaxseed oil and vitamin E...... be drawn from these studies for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of flaxseed oil and vitamin E and maintenance of the skin permeability barrier function...... is sufficiently characterised. The claimed effect is “contributes to maintain skin permeability barrier function”. The target population proposed by the applicant is healthy adults with dry and sensitive skin. Maintenance of the permeability barrier function of the skin is a beneficial physiological effect...

How many work-related injuries requiring hospitalization in British Columbia are claimed for workers' compensation?

Science.gov (United States)

Alamgir, Hasanat; Koehoorn, Mieke; Ostry, Aleck; Tompa, Emile; Demers, Paul A

2006-06-01

Workplace compensation claims datasets represent an important source of information on work-related injuries. This study investigated the concordance between hospital discharge records and workers' compensation records for work-related serious injuries among a cohort of sawmill workers in British Columbia (BC), Canada. It also examined the extent to which workers' compensation capturing patterns varied by cause, severity of injuries, and demographic characteristics of workers. Work-related injuries were identified in hospitalization records between April 1989 and December 1998, and were matched by dates and description of injury to compensation records. The agreement between the hospital records and compensation records was good (kappa = 0.84, P < 0.01). A lower claim reporting rate for work-related hospitalization was observed for older and non-white workers. More serious injuries defined by longer length of stay and emergency admissions were more likely to be reported. Falls, struck against, and overexertion injuries had lower reporting rates; whereas, machinery-related, cutting/piercing, and caught in/between injuries had higher reporting rates. When compared with hospital discharge records, the compensation agency underreported incidents of serious work-related injuries by 10-15% among the sawmill workers.

[Surgical procedures involved in claims for alleged defects in praxis].

Science.gov (United States)

Arimany-Manso, Josep; Benet-Travé, J; Bruguera-Cortada, M; Torné-Escasany, R; Klamburg-Pujol, J; Gómez-Durán, Esperanza L

2014-03-01

Medical professional liability and adverse events in health care are major concerns worldwide and the analysis of claims for alleged defects in praxis is a potential source of knowledge. High rates of adverse events and complaints have been reported in surgical procedures. This article analyzes the claims registered by the Council of Medical Colleges in Catalonia between 1986 and 2012, and explores surgical procedures claimed (ICD- 9-CM coding), as well as the final outcome of the claim. Among the 5,419 records identified on surgical procedures, the interventions of the musculoskeletal system and skin and integument showed the highest frequencies. Interventions related to "non-curative" medicine should be emphasized because of their higher rates of economical agreement or condemnation outcomes, which were significantly higher for mastopexia. The results underscore the importance of the surgical area in medical professional liability and the high risk of payouts among those procedures belonging to the so-called "non-curative" medicine. Copyright © 2014 Elsevier España, S.L. All rights reserved.

HEALTH INFO SANTE ANNUAL DEDUCTIBLE AND REIMBURSEMENT CLAIMS: HINTS FOR USE

CERN Multimedia

1999-01-01

Information from the CHIS Board and the Personnel DivisionOne should bear in mind that the annual deductible is an amount (currently CHF 100) charged automatically by the Administrator of the scheme for every adult aged 18 and above. This is what happens: The amount is deducted annually for all medical services received over a calendar year.It is triggered by the date of the treatment and not by the date of the bill nor that of the reimbursement claim.In other words, if you receive medical treatment in December for the first time in a given year, the CHF 100 will be deducted from the claim for that treatment. So, except for urgent cases, it would be better to wait till the following month, thus avoiding one annual deductible.It is also worth remembering that the cost of processing our reimbursement claims - and there were 55, 000 in 1998 - is part of the cost of our insurance.Help keep administrative costs down : do not submit reimbursement claims for amounts less than the annual deductible unless your claims...

The holistic claims of the biopsychosocial conception of WHO's International Classification of Functioning, Disability, and Health (ICF): a conceptual analysis on the basis of a pluralistic-holistic ontology and multidimensional view of the human being.

Science.gov (United States)

Solli, Hans Magnus; da Silva, António Barbosa

2012-06-01

The International Classification of Functioning, Disability and Health (ICF), designed by the WHO, attempts to provide a holistic model of functioning and disability by integrating a medical model with a social one. The aim of this article is to analyze the ICF's claim to holism. The following components of the ICF's complexity are analyzed: (1) health condition, (2) body functions and structures, (3) activity, (4) participation, (5) environmental factors, (6) personal factors, and (7) health. Although the ICF claims to be holistic, it presupposes a monistic materialistic ontology. We indicate some limitations of this ontology, proposing instead: (a) a pluralistic-holistic ontology (PHO) and (b) a multidimensional view of the human being, with individual and environmental aspects, in relation to three levels of reality implied by the PHO. For the ICF to attain its holistic claim, the interactions between its components should be based on (a) and (b).

Are people who claim compensation "cured by a verdict"? A longitudinal study of health outcomes after whiplash.

Science.gov (United States)

Spearing, Natalie M; Gyrd-Hansen, Dorte; Pobereskin, Louis H; Rowell, David S; Connelly, Luke B

2012-09-01

This study examines whether the lure of injury compensation prompts whiplash claimants to overstate their symptoms. Claim settlement is the intervention of interest, as it represents the point at which there is no further incentive to exaggerate symptoms, and neck pain at 24 months is the outcome of interest. Longitudinal data on neck pain scores and timing of claim settlement were regressed, controlling for the effect of time on recovery, to compare outcomes in claimants who had and had not settled their compensation claims. The results show clearly that removing the financial incentive to over-report symptoms has no effect on self-reported neck pain in a fault-based compensation scheme, and this finding concurs with other studies on this topic. Policy decisions to limit compensation in the belief that claimants systematically misrepresent their health status are not supported empirically Claimants do not appear to be "cured by a verdict".

Occupational injuries and diseases in Alberta : lost-time claims, disabling injury claims and claim rates in the upstream oil and gas industries, 2002 to 2006

Energy Technology Data Exchange (ETDEWEB)

NONE

2007-07-01

Alberta Employment, Immigration and Industry (EII) prepares an annual report of the occupational injuries and diseases in the upstream oil and gas industries operating in the province. The purpose is to determine if the industries meet the demand from industry and safety association, labour organizations, employers and workers to improve workplace health and safety. This report described programs and initiatives undertaken by EII in pursuit of these goals. It analyzed provincial occupational injury and disease information against national statistics and estimated the risk of injury or disease at the provincial, industry sector and sub-sector level. The report also presented an analysis of aggregate injury claim data to allow for the tracking of workplace health and safety performance over time. For comparative purposes, 2006 data was presented beside 2005 data. Additional historical data was presented in some cases. It was noted that approximately 80 per cent of employed persons in Alberta are covered by the Workman's Compensation Board (WCB). Therefore, this report focused on all industry activity in Alberta covered by the WCB and by the provincial legislation of occupational health and safety. General descriptions about the incidents and injured workers were presented along with fatality rates for the major industry sectors as well as the occupational fatalities that the Workers Compensation Board (WCB) accepted for compensation. The number of employers that earned a certificate of recognition was also identified. Injury and disease analysis was discussed in terms of injured worker characteristics; nature of injury or disease; source of injury or disease; type of event or exposure; and, duration of disability. It was shown that the lost-time claim rate for the upstream oil and gas industries in Alberta decreased by 10 per cent in 2006, due to fewer injury claims. The disabling injury rate decreased by 4.9 per cent. The tar sand subsector had the lowest lost

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the modification of the authorisation of a health claim related to cocoa flavanols and maintenance of normal endotheliumdependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

Following an application from Barry Callebaut Belgium NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification of the authoris......Following an application from Barry Callebaut Belgium NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification...... of the authorisation of a health claim related to “cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow”, pursuant to Article 13(5) of Regulation (EC) No 1924/2006. The modification concerns an extension of the authorised conditions of use of the claim to a high......-flavanols (HF) cocoa extract to be consumed in capsules, tablets or added to “other foods, including beverages”. Cocoa flavanols, which are the subject of the health claim, have been sufficiently characterised. Maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil and maintenance of normal hair pursuant to Article 13

DEFF Research Database (Denmark)

Tetens, Inge

Following two applications from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health...... claim related to a combination of thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil (Cucurbita pepo L.) and maintenance of normal hair. The Panel considers that the specified combination is sufficiently characterised. The claimed effects are “contributes to reduce......, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil (Cucurbita pepo L.) and maintenance of normal hair....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to “Appl’In® polyphenolic apple extract powder (Malus domestica)” and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Diana Naturals pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to “Appl....... The Panel considers that reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect. The applicant provided one published and two unpublished human studies, three animal studies and two...... in vitro studies as pertinent to the claim. The Panel notes that the food used in one human study did not comply with the specifications of the food which is the subject of the claim and considers that no conclusion can be drawn from this study for the scientific substantiation of the claim. In two other...

Impact of corporate social responsibility claims on consumer food choice

DEFF Research Database (Denmark)

Mueller Loose, Simone; Remaud, Hervé

2013-01-01

Purpose - The study assesses the impact of two different corporate social responsibility (CSR) claims, relating to social and environmental dimensions, on consumers’ wine choice across international markets. It is analysed how point of purchase CSR claims compete with other food claims and their ......Purpose - The study assesses the impact of two different corporate social responsibility (CSR) claims, relating to social and environmental dimensions, on consumers’ wine choice across international markets. It is analysed how point of purchase CSR claims compete with other food claims...... Eastcoast, the US Midwest, Anglophone and Francophone Canada. Findings - CSR claims relating to social and environmental responsibility have a similar awareness, penetration and consumer trust, but differ in their impact on consumer choice, where environmental corporate responsibility claims benefit from...... a higher marginal willingness to pay. Consumer valuation of CSR claims significantly differs across international markets, but is consistently lower than for organic claims. Research limitations/implications - The study was limited to wine and future research is required to generalise findings to other...

Understanding the impact of legislation on ‘reduction of disease risk’ claims on food and drinks

DEFF Research Database (Denmark)

Raats, Monique M.; Malcolm, Rosalind N.; Lähteenmäki, Liisa

2016-01-01

The Nutrition and Health Claims Regulation (EC No. 1924/2006) has established a common framework for the regulation of nutrition and health claims used on foods across the European Union. This regulation aims to provide the European food industry opportunities for product innovation whilst...... protecting consumer interests with respect to controlling misleading advertising and promoting public health. However, in order to satisfy the approval of new health claims procedure particularly for new ‘reduction of disease risk’ claims [Article 14(1)(a) claims] , significant research activity is required...

Critical thinking in Norwegian upper secondary biology education: The cases of complementary-alternative-medicine and health claims in the media

Directory of Open Access Journals (Sweden)

Sverre Pettersen

2005-11-01

Full Text Available By definition, complementary alternative medicine (CAM treatments are not scientifically proven. Scientific deficient health claiming news seems to flourish in the media. The aims of this questionnaire study was to explore: (1 attitudes towards CAM among 3rd year students of the health sciences in Norway, who either have immersed themselves in the 2nd and 3rd year upper secondary biology courses, or taken the 1st year compulsory natural science course, exclusively, and (2 these students’ skills in requesting for scientific information in highly deficient health news briefs. There were no significant differences in the frequencies of positive attitude towards the use of CAM treatments between the two health sciences student categories, and most students in both categories “failed” in the test set out to measure their skills in requesting for scientific information in four highly scientific deficient health news briefs. The results suggest that teaching of the Norwegian upper secondary biology courses does probably not contribute extensively to pupils’ development of scepticism towards CAM, and skills in evaluating health claims, scientifically.

Mediation as an alternative solution to medical malpractice court claims

Directory of Open Access Journals (Sweden)

Neels Claassen

2016-05-01

Full Text Available Is there a crisis in the healthcare industry? Most certainly there is. Dr Motsoaledi, Minister of Health, publicly acknowledged the existence of such a crisis at a Medico-Legal Summit held at his initiative in Pretoria on 9 and 10 March 2015 at St Georges Hotel.[1] Currently, as recently confirmed by the MEC for Health, Ms Mahlangu, there are about 2 000 pending court cases against the Gauteng Provincial Health Department, the total quantum being claimed amounting to approximately ZAR 3.5 billion. During 2013/2014 this department spent about ZAR 256 million on legal costs payable to claimants’ attorneys. No budget for these expenses exists, resulting in payment being made from funds designated for the acquisition of medical equipment and other purposes.[1] This undermines the department’s ability to renew old equipment and upgrade to more modern equipment, resulting in even further claims. More claims are therefore to be expected. The Medical Protection Society also confirmed an increase in medical malpractice claims against their members of nearly 550% compared to 10 years ago. The quantum of claims that exceeded ZAR 5 million per claim, also increased by 900%.[2,3] The ripple effect of these increases in medico-legal claims causes insurance premiums for healthcare professionals to become exorbitantly expensive, resulting in some practitioners leaving the medical profession. Practitioners also act more defensively in applying their trade, resulting in additional and sometimes unnecessary tests that increase the costs of medical care and often cause further grounds for the institution of claims.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium and beta-carotene and contribution to normal collagen formation (ID 1669) and protection, of the skin from UV-induced damage (ID 1669) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium and beta-carotene and contribution to normal collagen formation and protection of the skin from UV-induced damage. The scientific substantiation is based on the information provided by the Member States...... in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene. The Panel...... considers that the combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene is sufficiently characterised....

Severe and fatal obstetric injury claims in relation to labor unit volume

DEFF Research Database (Denmark)

Milland, Maria; Mikkelsen, Kim L; Christoffersen, Jens K

2015-01-01

with decreasing annual delivery volume. Face value incidence rate ratios of approved severe injuries increased with decreasing labor unit volume, but the association did not reach statistical significance. CONCLUSION: High volume labor units appear associated with fewer approved and fewer fatal injury claims...... in labor units in 1995-2012. METHODS: Exposure information regarding the annual number of deliveries per labor unit was retrieved from the Danish National Birth Register. Outcome information was retrieved from the Danish Patient Compensation Association. Exposure was categorized in delivery volume...... quintiles as annual volume per labor unit: (10-1377), (1378-2016), (2017-2801), (2802-3861), (3862-6659). MAIN OUTCOME MEASURES: Five primary measures of outcome were used. Incidence rate ratios of (A) Submitted claims, (B) Approved claims, (C) Approved severe injury claims (120% degree of disability), (D...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Barry Callebaut Belgium nv, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation...... of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. Cocoa flavanols are sufficiently characterised. The claimed effect is “help maintain endothelium-dependent vasodilation which contributes to healthy blood flow”. The target population proposed...... by the applicant is the general healthy adult population. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. In weighing the evidence, the Panel took into account that cocoa flavanols consumed for 12 weeks have been shown to increase fasting ED...

Analysis of 11 years of clinical negligence claims in esophagogastric cancer in England.

Science.gov (United States)

Ratnasingham, K; Stroud, L; Knight, J; Preston, S R; Sultan, J

2017-04-01

In the National Health Service (NHS), clinical negligence claims and associated compensations are constantly rising. The aim of this study is to identify the size, trends, and causes of litigations claims in relation to esophagogastric (EG) cancer in the NHS. Data requests were submitted to the NHS Litigation Authority (NHSLA) for the period of January 2003 to December 2013. Data were reviewed, categorized clinically, and analyzed in terms of causes and costs behind claims. In this time period, there were 163 claims identified from the NHSLA database. Ninety-five (58.3%) claims were successful with a pay out of £6.25 million. An increasing overall claim frequency and success rate were found over the last few years. Majority of the claims were from gastric cancer 84 (88.4%). The commonest cause of complaint in successful claims was delay or failure in diagnosis (21.1%) and treatment (17.9%). There were only 10.5% successful intraoperative claims, of which 50% were due to unnecessary or additional procedures. The frequency and success rates of malpractice claims in EG cancer are rising. The failure or delay in diagnosing and treatment in EG malignancy are the common cause for successful litigation claims. The findings further reinforce the need to improve early diagnosis. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Medical research using governments' health claims databases: with or without patients' consent?

Science.gov (United States)

Tsai, Feng-Jen; Junod, Valérie

2018-03-01

Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

[Work-related behaviour and experience patterns and mental health: a study in psychotherapy trainees].

Science.gov (United States)

Grundmann, Johanna; Sude, Kerstin; Löwe, Bernd; Wingenfeld, Katja

2013-03-01

In view of the fact that many reports have been published that emphasize the difficult conditions of the German psychotherapy training, the aim of this study was to investigate psychotherapy trainees´ work stress as well as work-related psychosocial risks and resources. Variables of interest were work-related behaviour and experience patterns (AVEM), effort-reward-imbalance, chronic stress and health-related quality of life. 321 participants completed an online survey. The distribution of work-related behaviour and experience patterns as well as the results regarding work overload and mental health are evidence of psychotherapy trainees' strain. AVEM-risk patterns are associated with effort-reward-imbalance, chronic stress and reduced mental health. These results clearly support claims for a modification of the psychotherapy training in Germany. © Georg Thieme Verlag KG Stuttgart · New York.

31 CFR 360.29 - Adjudication of claims.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false Adjudication of claims. 360.29 Section 360.29 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FISCAL... the ordinary course of business. (b) Claims filed 10 years after payment. Any claim filed 10 years or...

Consumers' Views Regarding Health Claims on Food Packages. Contextual Analysis by Means of Computer Support

Directory of Open Access Journals (Sweden)

Eva Gunilla Svederberg

2002-01-01

Full Text Available Several studies have shown consumers to generally have only a limited understanding of the nutritional information on packaged-food labels. This suggests it is difficult for them to select properly between different foods on the basis of such information. As a basis for information on the requirements of groups of consumers, the present study aimed at investigating how, when presented with health claims and other nutritional information on the labels of food products, consumers' thinking about foods is affected by various background factors as well as by various types of food-related experiences. Semi-structured interviews of 30 consumers in Sweden—men and women aged 25 to 64, with and without food-related health problems—were carried out. The interviews were tape-recorded and were transcribed word-for-word. In the analysis of the interview data, the qualitative methodology of contextual analysis was utilised. For the purpose of method development, the computer programme Atlas.ti was used to support the analysis. The objective of this article is to show step by step how the analysis was carried out. In connection with the analysis, some results are presented. However, the focus in the article is on methodology. The conclusion drawn is that Atlas.ti has qualities that can facilitate the contextual analysis of the interview data. URN: urn:nbn:de:0114-fqs0201109

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to “non - fermentable ” carbohydrates and maintenance of tooth mineralisation by decreasing tooth demineralisation pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

on the scientific substantiation of a health claim related to Nutriose® which should replace “fermentable carbohydrates” in foods or beverages in order to obtain the claimed effect, i.e. maintenance of tooth mineralisation by reducing tooth demineralisation. From the information provided, the Panel noted......” carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel considers that maintaining tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque caused by the fermentation of carbohydrates is a beneficial physiological effect. The Panel concludes...... that a cause and effect relationship has been established between the consumption of foods/beverages containing “fermentable” carbohydrates at an exposure frequency of four or more times daily and an increased tooth demineralisation, and that the consumption of foods/beverages containing “non...

32 CFR 536.121 - Claims not payable as maritime claims.

Science.gov (United States)

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Claims not payable as maritime claims. 536.121... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.121 Claims not payable as maritime claims... (except at (e) and (k)), and 536.46; (b) Are not maritime in nature; (c) Are not in the best interests of...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . Scientific Opinion on the substantiation of a health claim related to VeriSol ® P and a change in skin elasticity leading to an improvement in skin function pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

related to VeriSol®P and a change in skin elasticity leading to an improvement in skin function. The Panel considers that the food, VeriSol®P, which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “maintenance of skin health, as indicated...... by an increased skin elasticity and a reduction of wrinkles volume”. The target population proposed by the applicant is the general adult population. The Panel considers that a change in skin elasticity leading to an improvement in skin function is a beneficial physiological effect. The applicant presented two...... of VeriSol®P and a change in skin elasticity leading to an improvement in skin function. © European Food Safety Authority, 2013...

Born Fat: The Relations between Weight Changeability Beliefs and Health Behaviors and Physical Health

Science.gov (United States)

Parent, Mike C.; Alquist, Jessica L.

2016-01-01

Although some popular press and nonscholarly sources have claimed that weight is largely unchangeable, the relationship between this belief and objective measures of health remains unclear. We tested the hypothesis that people who believe weight is unchangeable will have poorer objective and subjective health, and fewer exercise behaviors and…

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C-reactive protein” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C‑reactive protein”. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect is “helps to support joint function by maintaining low levels of plasma...

Database and Registry Research in Orthopaedic Surgery: Part I: Claims-Based Data.

Science.gov (United States)

Pugely, Andrew J; Martin, Christopher T; Harwood, Jared; Ong, Kevin L; Bozic, Kevin J; Callaghan, John J

2015-08-05

The use of large-scale national databases for observational research in orthopaedic surgery has grown substantially in the last decade, and the data sets can be grossly categorized as either administrative claims or clinical registries. Administrative claims data comprise the billing records associated with the delivery of health-care services. Orthopaedic researchers have used both government and private claims to describe temporal trends, geographic variation, disparities, complications, outcomes, and resource utilization associated with both musculoskeletal disease and treatment. Medicare claims comprise one of the most robust data sets used to perform orthopaedic research, with >45 million beneficiaries. The U.S. government, through the Centers for Medicare & Medicaid Services, often uses these data to drive changes in health policy. Private claims data used in orthopaedic research often comprise more heterogeneous patient demographic samples, but allow longitudinal analysis similar to that offered by Medicare claims. Discharge databases, such as the U.S. National Inpatient Sample, provide a wide national sampling of inpatient hospital stays from all payers and allow analysis of associated adverse events and resource utilization. Administrative claims data benefit from the high patient numbers obtained through a majority of hospitals. Using claims, it is possible to follow patients longitudinally throughout encounters irrespective of the location of the institution delivering health care. Some disadvantages include lack of precision of ICD-9 (International Classification of Diseases, Ninth Revision) coding schemes. Much of these data are expensive to purchase, complicated to organize, and labor-intensive to manipulate--often requiring trained specialists for analysis. Given the changing health-care environment, it is likely that databases will provide valuable information that has the potential to influence clinical practice improvement and health policy for

Counting the cost of negligence in neurosurgery: Lessons to be learned from 10 years of claims in the NHS.

Science.gov (United States)

Hamdan, Alhafidz; Strachan, Roger D; Nath, Fredrick; Coulter, Ian C

2015-04-01

Despite substantial progress in modernising neurosurgery, the specialty still tops the list of medico-legal claims. Understanding the factors associated with negligence claims is vital if we are to identify areas of underperformance and subsequently improve patient safety. Here we provide data on trends in neurosurgical negligence claims over a 10-year period in England. We used data provided by the National Health Service Litigation Authority to analyse negligence claims related to neurosurgery from the financial years 2002/2003 to 2011/2012. Using the abstracts provided, we extracted information pertaining to the underlying pathology, injury severity, nature of misadventure and claim value. Over the 10-year period, the annual number of claims increased significantly. In total, there were 794 negligence claims (range 50-117/year); of the 613 closed cases, 405 (66.1%) were successful. The total cost related to claims during the 10 years was £65.7 million, with a mean claim per successful case of £0.16 million (total damages, defence and claimant costs of £45.1, £6.36 and £14.3 million, respectively). Claims related to emergency cases were more costly compared to those of elective cases (£209,327 vs. £112,627; P=0.002). Spinal cases represented the most frequently litigated procedures (350; 44.1% of total), inadequate surgical performance the most common misadventure (231; 29.1%) and fatality the commonest injury implicated in claims (102; 12.8%). Negligence claims related to wrong-site surgery and cauda equina syndrome were frequently successful (26/26; 100% and 14/16; 87.5% of closed cases, respectively). In England, the number of neurosurgical negligence claims is increasing, the financial cost substantial, and the burden significant. Lessons to be learned from the study are of paramount importance to reduce future cases of negligence and improve patient care.

Vitamin D metabolism, functions and needs: from science to health claims.

Science.gov (United States)

Battault, S; Whiting, S J; Peltier, S L; Sadrin, S; Gerber, G; Maixent, J M

2013-03-01

Vitamin D is a nutrient long considered as essential for skeletal health but is now attracting interest from medical and nutritional communities as knowledge emerges of its biological function and its association with decreased risk of many chronic diseases. A question emerges: How much more vitamin D do we need for these new functions of vitamin D? This review discusses vitamin D physiology and hypovitaminosis D and presents two vitamin D dietary policies: that according to regulatory authorities and that of nutrition scientists. Scientific evidence suggests that 25(OH)D serum levels should be over 75 nmol/L; otherwise, there is no beneficial effect of vitamin D on long-latency diseases. Current regulatory authority recommendations are insufficient to reach this level of adequacy. Observational and some prospective data show that vitamin D has a role in the prevention of cancer as well as immunity, diabetes and cardiovascular and muscle disorders, which supports the actions of 1α,25(OH)2D at cellular and molecular levels. The recent assessments done by the European Food Safety Authority should lead to new health claims. Vitamin D, through food fortification and supplementation, is a promising new health strategy and thus provides opportunities for food industry and nutrition researchers to work together towards determining how to achieve this potential health benefit.

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

Science.gov (United States)

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...

Claims in vapour device (e-cigarette) regulation: A Narrative Policy Framework analysis.

Science.gov (United States)

O'Leary, Renée; Borland, Ron; Stockwell, Tim; MacDonald, Marjorie

2017-06-01

The electronic cigarette or e-cigarette (vapour device) is a consumer product undergoing rapid growth, and governments have been adopting regulations on the sale of the devices and their nicotine liquids. Competing claims about vapour devices have ignited a contentious debate in the public health community. What claims have been taken up in the state arena, and how have they possibly influenced regulatory outcomes? This study utilized Narrative Policy Framework to analyze the claims made about vapour devices in legislation recommendation reports from Queensland Australia, Canada, and the European Union, and the 2016 deeming rule legislation from the United States, and examined the claims and the regulatory outcomes in these jurisdictions. The vast majority of claims in the policy documents represented vapour devices as a threat: an unsafe product harming the health of vapour device users, a gateway product promoting youth tobacco uptake, and a quasi-tobacco product impeding tobacco control. The opportunity for vapour devices to promote cessation or reduce exposure to toxins was very rarely presented, and these positive claims were not discussed at all in two of the four documents studied. The dominant claims of vapour devices as a public health threat have supported regulations that have limited their potential as a harm reduction strategy. Future policy debates should evaluate the opportunities for vapour devices to decrease the health and social burdens of the tobacco epidemic. Copyright © 2017 Elsevier B.V. All rights reserved.

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

Science.gov (United States)

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

2017-01-01

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

Chiropractic claims in the English-speaking world.

Science.gov (United States)

Ernst, Edzard; Gilbey, Andrew

2010-04-09

Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence). A review of 200 chiropractor websites and 9 chiropractic associations' World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment. We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain, The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

48 CFR 1652.204-72 - Filing health benefit claims/court review of disputed claims.

Science.gov (United States)

2010-10-01

... beyond his or her control from making the request within the time limit. (2) The Carrier has 30 days... information is required to make a decision on the claim; (iii) Specify the time limit (60 days after the date... that time and give a written notice of its decision to the covered individual and to the Carrier. (f...

Treatment patterns and health care resource utilization associated with dalfampridine extended release in multiple sclerosis: a retrospective claims database analysis

Directory of Open Access Journals (Sweden)

Guo A

2016-05-01

Full Text Available Amy Guo,1 Michael Grabner,2 Swetha Rao Palli,2 Jessica Elder,1 Matthew Sidovar,1 Peter Aupperle,1 Stephen Krieger3 1Acorda Therapeutics Inc., Ardsley, New York, NY, USA; 2HealthCore Inc., Wilmington, DE, USA; 3Corinne Goldsmith Dickinson Center for MS, Icahn School of Medicine at Mount Sinai, New York, NY, USA Background: Although previous studies have demonstrated the clinical benefits of dalfampridine extended release (D-ER tablets in patients with multiple sclerosis (MS, there are limited real-world data on D-ER utilization and associated outcomes in patients with MS. Purpose: The objective of this study was to evaluate treatment patterns, budget impact, and health care resource utilization (HRU associated with D-ER use in a real-world setting. Methods: A retrospective claims database analysis was conducted using the HealthCore Integrated Research DatabaseSM. Adherence (measured by medication possession ratio, or [MPR] and persistence (measured by days between initial D-ER claim and discontinuation or end of follow-up were evaluated over 1-year follow-up. Budget impact was calculated as cost per member per month (PMPM over the available follow-up period. D-ER and control cohorts were propensity-score matched on baseline demographics, comorbidities, and MS-related resource utilization to compare walking-impairment-related HRU over follow-up. Results: Of the 2,138 MS patients identified, 1,200 were not treated with D-ER (control and 938 were treated with D-ER. Patients were aged 51 years on average and 74% female. Approximately 82.6% of D-ER patients were adherent (MPR >80%. The estimated budget impact range of D-ER was $0.014–$0.026 PMPM. Propensity-score-matched D-ER and controls yielded 479 patients in each cohort. Postmatching comparison showed that the D-ER cohort was associated with fewer physician (21.5% vs 62.4%, P<0.0001 and other outpatient visits (22.8% vs 51.4%, P<0.0001 over the 12-month follow-up. Changes in HRU from follow

32 CFR 536.129 - Claims cognizable as UCMJ claims.

Science.gov (United States)

2010-07-01

... Personnel Claims Act and chapter 11 of AR 27-20, which provides compensation only for tangible personal... 32 National Defense 3 2010-07-01 2010-07-01 true Claims cognizable as UCMJ claims. 536.129 Section 536.129 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS...

Second WCB claims: who is at risk?

Science.gov (United States)

Cherry, Nicola M; Sithole, Fortune; Beach, Jeremy R; Burstyn, Igor

2010-01-01

Many workers with one Workers' Compensation Board (WCB) claim make further claims. If the characteristics of the job, initial injury or worker were predictive of an early second claim, interventions at the time of return to work after the first claim might be effective in reducing the burden of work-related injury. This report explores the characteristic of those who make a second claim. Records of all Alberta WCB claims from January 1, 1995, to December 31, 2004, for individuals 18 to claim, sex and age of claimant, type of injury, type of accident, occupation, industry, an indicator of company size, and industry claim rate were extracted, as well as the date of any second claim. The likelihood of second claim and mean time to second claim were estimated. Multivariate analyses were performed using Cox regression. 1,047,828 claims were identified from 490,230 individuals. Of these, 49.2% had at least two claims. In the multivariate model a reduced time to second claim was associated with male sex, younger age and some types of injury and accident. Machining trades were at highest risk of early second claim (hazard ratio [HR] 2.54 compared with administration), and of the industry sectors manufacturing was at highest risk (HR 1.37 compared with business, personal and professional services). Some caution is needed in interpreting these data as they may be affected by under-reporting and job changes between claims. Nonetheless, they suggest that there remains room for interventions to reduce the considerable differences in risk of a second claim among workers, jobs and industries.

Using "big data" to capture overall health status: properties and predictive value of a claims-based health risk score.

Science.gov (United States)

Hamad, Rita; Modrek, Sepideh; Kubo, Jessica; Goldstein, Benjamin A; Cullen, Mark R

2015-01-01

Investigators across many fields often struggle with how best to capture an individual's overall health status, with options including both subjective and objective measures. With the increasing availability of "big data," researchers can now take advantage of novel metrics of health status. These predictive algorithms were initially developed to forecast and manage expenditures, yet they represent an underutilized tool that could contribute significantly to health research. In this paper, we describe the properties and possible applications of one such "health risk score," the DxCG Intelligence tool. We link claims and administrative datasets on a cohort of U.S. workers during the period 1996-2011 (N = 14,161). We examine the risk score's association with incident diagnoses of five disease conditions, and we link employee data with the National Death Index to characterize its relationship with mortality. We review prior studies documenting the risk score's association with other health and non-health outcomes, including healthcare utilization, early retirement, and occupational injury. We find that the risk score is associated with outcomes across a variety of health and non-health domains. These examples demonstrate the broad applicability of this tool in multiple fields of research and illustrate its utility as a measure of overall health status for epidemiologists and other health researchers.

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

Science.gov (United States)

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.

22 CFR 213.3 - Loans, guarantees, sovereign and interagency claims.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Loans, guarantees, sovereign and interagency claims. 213.3 Section 213.3 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT CLAIMS COLLECTION... thereof, or any public international organization; (d) Claims where the CFO determines that the...

Scientific Evaluation and Review of Claims in Health Care (SEaRCH): A Streamlined, Systematic, Phased Approach for Determining "What Works" in Healthcare.

Science.gov (United States)

Jonas, Wayne B; Crawford, Cindy; Hilton, Lara; Elfenbaum, Pamela

2017-01-01

Answering the question of "what works" in healthcare can be complex and requires the careful design and sequential application of systematic methodologies. Over the last decade, the Samueli Institute has, along with multiple partners, developed a streamlined, systematic, phased approach to this process called the Scientific Evaluation and Review of Claims in Health Care (SEaRCH™). The SEaRCH process provides an approach for rigorously, efficiently, and transparently making evidence-based decisions about healthcare claims in research and practice with minimal bias. SEaRCH uses three methods combined in a coordinated fashion to help determine what works in healthcare. The first, the Claims Assessment Profile (CAP), seeks to clarify the healthcare claim and question, and its ability to be evaluated in the context of its delivery. The second method, the Rapid Evidence Assessment of the Literature (REAL © ), is a streamlined, systematic review process conducted to determine the quantity, quality, and strength of evidence and risk/benefit for the treatment. The third method involves the structured use of expert panels (EPs). There are several types of EPs, depending on the purpose and need. Together, these three methods-CAP, REAL, and EP-can be integrated into a strategic approach to help answer the question "what works in healthcare?" and what it means in a comprehensive way. SEaRCH is a systematic, rigorous approach for evaluating healthcare claims of therapies, practices, programs, or products in an efficient and stepwise fashion. It provides an iterative, protocol-driven process that is customized to the intervention, consumer, and context. Multiple communities, including those involved in health service and policy, can benefit from this organized framework, assuring that evidence-based principles determine which healthcare practices with the greatest promise are used for improving the public's health and wellness.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to high-fibre sourdough rye bread and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

responses when compared with glucose. The Panel also notes that, when comparable amounts of available carbohydrates from different carbohydrate-containing foods are tested, almost any carbohydrate-containing food would induce a reduction of post-prandial blood glucose responses compared with glucose....... In addition, foods containing low amounts of, or no available carbohydrates, will also induce lower post-prandial blood glucose responses when compared with glucose. The Panel concludes that a cause and effect relationship has been established between the consumption of almost any food and a reduction of post...... on the scientific substantiation of a health claim related to high‑fibre sourdough rye bread and a reduction of post-prandial glycaemic responses. The Panel considers that the food, high-fibre sourdough rye bread, and its “comparator”, glucose, are sufficiently characterised in relation to the claimed effect...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to fructose and reduction of post-prandial glycaemic responses (ID 558) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

which fructose should replace in foods or beverages in order to obtain the claimed effect, sucrose and glucose, are sufficiently characterised. The claimed effect is “carbohydrate metabolism and insulin sensitivity”. The Panel assumes that the target population is individuals who wish to reduce...... the claim, glucose or sucrose should be replaced by fructose in sugar sweetened foods or beverages. The target population is individuals who wish to reduce their post-prandial glycaemic responses. The Panel notes that high intakes of fructose may lead to metabolic complications such as dyslipidaemia...... stakeholders. The food constituent that is the subject of the health claim is fructose. From the information provided, the Panel assumes that fructose should replace sucrose or glucose in foods or beverages in order to obtain the claimed effect. The Panel considers that fructose, and the food constituents...

21 CFR 101.83 - Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).

Science.gov (United States)

2010-04-01

... factors for CHD is a major public health goal that can assist in reducing risk of CHD. High blood total... LDL cholesterol levels. (c) Requirements—(1) General. All requirements set forth in § 101.14 shall be... benefits of exercise and management of body weight to help lower the risk of heart disease. (2) The claim...

Claim rates of compensable back injuries by age, gender, occupation, and industry. Do they relate to return-to-work experience?

Science.gov (United States)

Gluck, J V; Oleinick, A

1998-07-15

A retrospective cohort study of Michigan workers' compensation cases involving back injuries in 1986 and 1987 with incidence and outcome data. To determine claim rates by age, gender, and industry or occupation for compensable back injuries and to investigate the relation between occupation and return to work. The cohort of 24,094 Michigan workers' compensation cases from 1986 and 1987 in which claimants were compensated for back injuries was reviewed. Compensation eligibility requires more than 7 days' disability after injury. Claim rates for back injuries by age, gender, and industry or occupation using employment data interpolated from 1980 and 1990 Census 1% Public Use Microdata Samples. Cox proportional hazards analysis was performed for return to work in the first 8 weeks after injury, with occupation coded at the three-digit level. All-age claim rates for Michigan compensable back injuries by occupation ranged between 0.03% and 1.7% annually (0.39% for all cases) and were generally higher in women in white collar occupations and in men in blue collar occupations. The claim rate peaked in men in the 25-34 year range, with the highest rates in manual labor occupations. The peak claim rates by age were less marked in women, tending to occur broadly throughout the 25-44-year range. Similar all-age values were recorded by industry. The male-to-female risk ratio over all occupations does not vary by age and is approximately 1.4:1. As the classification of occupation became more detailed, large differences in risk were documented within major occupation groups. The highest risk in this study was approximately 6% annually for 25-44 year old men in driver-sales (beverage truck drivers and delivery workers). Only 7 of 40 occupation categories showed a significant relative hazard for return to work in the first 8 weeks after injury, and these were blue collar occupations with earlier return than the reference sales category. For Michigan compensable back injuries, a

L-carnitine and contribution to normal lipid metabolism: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2018-01-01

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scien......Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

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

Science.gov (United States)

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 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 balance in covariates typically unmeasured in administrative claims datasets, to the extent that residual confounding is unlikely. © 2017 John Wiley & Sons Ltd.

The relationship of unions to prevalence and claim filing for work-related upper-extremity musculoskeletal disorders.

Science.gov (United States)

Morse, Tim; Punnett, Laura; Warren, Nicholas; Dillon, Charles; Warren, Andrew

2003-07-01

Unionization has been found to be related to higher filing of workers' compensation (WC) claims, but the extent of the relationship and the relationships to other variables have not been previously reported. Telephone interviews were conducted with both a population-based and WC-based samples of musculoskeletal disorder (MSD) cases. Workers at unionized facilities were 5.7 times (95% CI 2.5-13.1) more likely to file a claim for WC, despite a comparable rate of MSD cases. Higher filing was also associated with several measures of MSD severity (1.8-14.1 odds ratios), economic sector (OR = 10.1 for manufacturing), hourly (vs. salary) wages (OR = 2.6), and for having a personal physician (OR = 2.5). Unions appeared to have a protective effect on social effects of work-related MSD. Unions appear to improve filing of work-related MSD, particularly for less severe conditions. The higher filing does not appear to be a case of "moral hazard," but rather improved and earlier reporting, as is advocated by early intervention approaches to reducing MSD. Copyright 2003 Wiley-Liss, Inc.

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

Science.gov (United States)

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

ClaimAssociationService

Data.gov (United States)

Department of Veterans Affairs — Retrieves and updates a veteranÆs claim status and claim-rating association (claim association for current rating) from the Corporate database for a claim selected...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion Part II on the substantiation of health claims related to various food(s)/food constituent(s) not supported by pertinent human data (ID 406, 462, 472, 543, 659, 678, 696, 858, 1381, 1403, 1437, 1438, 1513, 1536, 1537, , 1538, 1539, 1540, 1543, 1613, 1627, 1855, 1860, 1981, 2126, 2514, 3127, 4038, 4501, 4672, 4712, 4718) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to various food(s)/food constituent(s) not supported by pertinent human data. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... evaluated in this opinion. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effects evaluated in this opinion....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion Part III on the substantiation of health claims related to various food(s)/food constituent(s) not supported by pertinent human data (ID 644, 946, 1717, 1730, 1742, 1760, 1871, 1894, 1910, 1926, 1933, 2000, 2024, , 2028, 2095, 2124, 2127, 2137, 2213, 2332, 2337, 2380, 2435, 2833, 2917, 3072, 3075, 3080, 3129, 3193, 3636, 4037, 4044, 4313) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to various food(s)/food constituent(s) not supported by pertinent human data. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... evaluated in this opinion. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effects evaluated in this opinion....

Health Care, Health Insurance, and the Relative Income of the Elderly and Nonelderly

OpenAIRE

Gary Burtless; Pavel Svaton

2009-01-01

Cash income offers an incomplete picture of the resources available to finance household consumption. Most American families are covered by an insurance plan that pays for some or all of the health care they consume. Only a comparatively small percentage of families pay for the full cost of this insurance out of their cash incomes. As health care has claimed a growing share of consumption, the percentage of care that is financed out of household incomes has declined. Because health care consu...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to isolated soy protein and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from the European Natural Soyfood Manufacturers Association (ENSA), the European Vegetable Protein Federation (EUVEPRO) and the Soya Protein Association (SPA), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel...... on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to isolated soy protein (ISP) and reduction of blood LDL-cholesterol concentrations, referring to disease risk reduction. The food constituent that is the subject...

76 FR 37207 - Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals...

Science.gov (United States)

2011-06-24

... Department of Health and Human Services 45 CFR Part 147 Group Health Plans and Health Insurance Issuers... SERVICES [CMS-9993-IFC2] 45 CFR Part 147 RIN 0938-AQ66 Group Health Plans and Health Insurance Issuers... for group health plans and health insurance coverage in the group and individual markets under...

Scientific Evaluation and Review of Claims in Health Care (SEaRCH): A Streamlined, Systematic, Phased Approach for Determining “What Works” in Healthcare

Science.gov (United States)

Crawford, Cindy; Hilton, Lara; Elfenbaum, Pamela

2017-01-01

Abstract Background: Answering the question of “what works” in healthcare can be complex and requires the careful design and sequential application of systematic methodologies. Over the last decade, the Samueli Institute has, along with multiple partners, developed a streamlined, systematic, phased approach to this process called the Scientific Evaluation and Review of Claims in Health Care (SEaRCH™). The SEaRCH process provides an approach for rigorously, efficiently, and transparently making evidence-based decisions about healthcare claims in research and practice with minimal bias. Methods: SEaRCH uses three methods combined in a coordinated fashion to help determine what works in healthcare. The first, the Claims Assessment Profile (CAP), seeks to clarify the healthcare claim and question, and its ability to be evaluated in the context of its delivery. The second method, the Rapid Evidence Assessment of the Literature (REAL©), is a streamlined, systematic review process conducted to determine the quantity, quality, and strength of evidence and risk/benefit for the treatment. The third method involves the structured use of expert panels (EPs). There are several types of EPs, depending on the purpose and need. Together, these three methods—CAP, REAL, and EP—can be integrated into a strategic approach to help answer the question “what works in healthcare?” and what it means in a comprehensive way. Discussion: SEaRCH is a systematic, rigorous approach for evaluating healthcare claims of therapies, practices, programs, or products in an efficient and stepwise fashion. It provides an iterative, protocol-driven process that is customized to the intervention, consumer, and context. Multiple communities, including those involved in health service and policy, can benefit from this organized framework, assuring that evidence-based principles determine which healthcare practices with the greatest promise are used for improving the public's health and

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

Science.gov (United States)

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.

Frequent Users of Hospital Emergency Departments in Korea Characterized by Claims Data from the National Health Insurance: A Cross Sectional Study

Science.gov (United States)

Woo, Jung Hoon; Grinspan, Zachary; Shapiro, Jason; Rhee, Sang Youl

2016-01-01

The Korean National Health Insurance, which provides universal coverage for the entire Korean population, is now facing financial instability. Frequent emergency department (ED) users may represent a medically vulnerable population who could benefit from interventions that both improve care and lower costs. To understand the nature of frequent ED users in Korea, we analyzed claims data from a population-based national representative sample. We performed both bivariate and multivariable analyses to investigate the association between patient characteristics and frequent ED use (4+ ED visits in a year) using claims data of a 1% random sample of the Korean population, collected in 2009. Among 156,246 total ED users, 4,835 (3.1%) were frequent ED users. These patients accounted for 14% of 209,326 total ED visits and 17.2% of $76,253,784 total medical expenses generated from all ED visits in the 1% data sample. Frequent ED users tended to be older, male, and of lower socio-economic status compared with occasional ED users (p users had longer stays in the hospital when admitted, higher probability of undergoing an operative procedure, and increased mortality. Among 8,425 primary diagnoses, alcohol-related complaints and schizophrenia showed the strongest positive correlation with the number of ED visits. Among the frequent ED users, mortality and annual outpatient department visits were significantly lower in the alcohol-related patient subgroup compared with other frequent ED users; furthermore, the rate was even lower than that for non-frequent ED users. Our findings suggest that expanding mental health and alcohol treatment programs may be a reasonable strategy to decrease the dependence of these patients on the ED. PMID:26809051

Linked Patient-Reported Outcomes Data From Patients With Multiple Sclerosis Recruited on an Open Internet Platform to Health Care Claims Databases Identifies a Representative Population for Real-Life Data Analysis in Multiple Sclerosis.

Science.gov (United States)

Risson, Valery; Ghodge, Bhaskar; Bonzani, Ian C; Korn, Jonathan R; Medin, Jennie; Saraykar, Tanmay; Sengupta, Souvik; Saini, Deepanshu; Olson, Melvin

2016-09-22

An enormous amount of information relevant to public health is being generated directly by online communities. To explore the feasibility of creating a dataset that links patient-reported outcomes data, from a Web-based survey of US patients with multiple sclerosis (MS) recruited on open Internet platforms, to health care utilization information from health care claims databases. The dataset was generated by linkage analysis to a broader MS population in the United States using both pharmacy and medical claims data sources. US Facebook users with an interest in MS were alerted to a patient-reported survey by targeted advertisements. Eligibility criteria were diagnosis of MS by a specialist (primary progressive, relapsing-remitting, or secondary progressive), ≥12-month history of disease, age 18-65 years, and commercial health insurance. Participants completed a questionnaire including data on demographic and disease characteristics, current and earlier therapies, relapses, disability, health-related quality of life, and employment status and productivity. A unique anonymous profile was generated for each survey respondent. Each anonymous profile was linked to a number of medical and pharmacy claims datasets in the United States. Linkage rates were assessed and survey respondents' representativeness was evaluated based on differences in the distribution of characteristics between the linked survey population and the general MS population in the claims databases. The advertisement was placed on 1,063,973 Facebook users' pages generating 68,674 clicks, 3719 survey attempts, and 651 successfully completed surveys, of which 440 could be linked to any of the claims databases for 2014 or 2015 (67.6% linkage rate). Overall, no significant differences were found between patients who were linked and not linked for educational status, ethnicity, current or prior disease-modifying therapy (DMT) treatment, or presence of a relapse in the last 12 months. The frequencies of the

A probabilistic method for computing quantitative risk indexes from medical injuries compensation claims.

Science.gov (United States)

Dalle Carbonare, S; Folli, F; Patrini, E; Giudici, P; Bellazzi, R

2013-01-01

The increasing demand of health care services and the complexity of health care delivery require Health Care Organizations (HCOs) to approach clinical risk management through proper methods and tools. An important aspect of risk management is to exploit the analysis of medical injuries compensation claims in order to reduce adverse events and, at the same time, to optimize the costs of health insurance policies. This work provides a probabilistic method to estimate the risk level of a HCO by computing quantitative risk indexes from medical injury compensation claims. Our method is based on the estimate of a loss probability distribution from compensation claims data through parametric and non-parametric modeling and Monte Carlo simulations. The loss distribution can be estimated both on the whole dataset and, thanks to the application of a Bayesian hierarchical model, on stratified data. The approach allows to quantitatively assessing the risk structure of the HCO by analyzing the loss distribution and deriving its expected value and percentiles. We applied the proposed method to 206 cases of injuries with compensation requests collected from 1999 to the first semester of 2007 by the HCO of Lodi, in the Northern part of Italy. We computed the risk indexes taking into account the different clinical departments and the different hospitals involved. The approach proved to be useful to understand the HCO risk structure in terms of frequency, severity, expected and unexpected loss related to adverse events.

Medico-legal claims against English radiologists: 1995-2006.

Science.gov (United States)

Halpin, S F S