WorldWideScience

Sample records for health claim related

  1. Perceived relevance and foods with health-related claims

    DEFF Research Database (Denmark)

    Dean, M.; Lampila, P.; Shepherd, R.

    2012-01-01

    consumers’ responses to health claims that either promise to reduce a targeted disease risk or improve well-being in comparison to other types of health-related messages, and how attitudes towards nutritionally healthy eating, functional food and previous experience relating to products with health claims...... affect the consumers’ perceptions of nutrition and health claims. The data (N = 2385) were collected by paper and pencil surveys in Finland, the UK, Germany and Italy on a target group of consumers over 35 year old, solely or jointly responsible for the family’s food shopping. The results showed...... risk reduction with detailed information about function and health outcome. Previous experience with products with health claims and interest in nutritionally healthy eating promoted the utility of all claims, regardless of whether they were health or nutrition claims. However, to be influenced...

  2. Electronic Health Record-Related Events in Medical Malpractice Claims.

    Science.gov (United States)

    Graber, Mark L; Siegal, Dana; Riah, Heather; Johnston, Doug; Kenyon, Kathy

    2015-11-06

    There is widespread agreement that the full potential of health information technology (health IT) has not yet been realized and of particular concern are the examples of unintended consequences of health IT that detract from the safety of health care or from the use of health IT itself. The goal of this project was to obtain additional information on these health IT-related problems, using a mixed methods (qualitative and quantitative) analysis of electronic health record-related harm in cases submitted to a large database of malpractice suits and claims. Cases submitted to the CRICO claims database and coded during 2012 and 2013 were analyzed. A total of 248 cases (<1%) involving health IT were identified and coded using a proprietary taxonomy that identifies user- and system-related sociotechnical factors. Ambulatory care accounted for most of the cases (146 cases). Cases were most typically filed as a result of an error involving medications (31%), diagnosis (28%), or a complication of treatment (31%). More than 80% of cases involved moderate or severe harm, although lethal cases were less likely in cases from ambulatory settings. Etiologic factors spanned all of the sociotechnical dimensions, and many recurring patterns of error were identified. Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future. The likelihood of harm seems to relate more to a patient's particular situation than to any one class of error.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share thework provided it is properly cited. The work cannot be changed in any way or used

  3. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) t to draft guidance on scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. 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 these areas. It is not intended that the document should include an exhaustive list of beneficial effects...

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

    NARCIS (Netherlands)

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

    2015-01-01

    Health claims and symbols are potential aids to help consumers identify foods that are healthier options. However, little is known as to how health claims and symbols are used by consumers in real-world shopping situations, thus making the science-based formulation of new labelling policies and

  5. Consumers’ Health-Related Motive Orientations and Reactions to Claims about Dietary Calcium

    Directory of Open Access Journals (Sweden)

    Christine Hoefkens

    2013-01-01

    Full Text Available Health claims may contribute to better informed and healthier food choices and to improved industrial competitiveness by marketing foods that support healthier lifestyles in line with consumer preferences. With the more stringent European Union regulation of nutrition and health claims, insights into consumers’ health-related goal patterns and their reactions towards such claims are needed to influence the content of lawful claims. This study investigated how consumers’ explicit and implicit health-related motive orientations (HRMOs together with the type of calcium-claim (nutrition claim, health claim and reduction of disease risk claim influence perceived credibility and purchasing intention of calcium-enriched fruit juice. Data were collected in April 2006 through a consumer survey with 341 Belgian adults. The findings indicate that stronger implicit HRMOs (i.e., indirect benefits of calcium for personal health are associated with higher perceived credibility, which is not (yet translated into a higher purchasing intention. Consumers’ explicit HRMOs, which refer to direct benefits or physiological functions of calcium in the body — as legally permitted in current calcium-claims in the EU — do not associate with reactions to the claims. Independently of consumers’ HRMOs, the claim type significantly affects the perceived credibility and purchasing intention of the product. Implications for nutrition policy makers and food industries are discussed.

  6. 76 FR 44491 - Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals...

    Science.gov (United States)

    2011-07-26

    ... 37208) entitled, ``Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims..., ``Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and... external review processes for group health plans and health insurance issuers offering coverage in the...

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

    DEFF Research Database (Denmark)

    Hieke, Sophie; Cascanette, Tamara; Pravst, Igor

    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...... (“The Role of health-related CLaims and sYMBOLs in consumer behaviour”) is an EU-funded project aiming to study how health claims and symbols influence consumer understanding, purchase and consumption behaviour. During a 4-year period, a wide range of research studies have been conducted across Europe......, in order to analyse European consumer behaviour in the context of health claims and symbols. Results of the studies will provide a basis for recommendations for stakeholders such as policy makers, the food industry and consumer and patient organisations....

  8. Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health (Revision 1)

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2018-01-01

    of additional health claim applications related to antioxidants, oxidative damage and cardiovascular health, and the information collected from a Grant launched in 2014. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the antioxidants......EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. The update takes into accounts experiences gained with evaluation......, oxidative damage and cardiovascular health. The document was subject to public consultation (from 12 July to 3 September 2017). This document supersedes the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011...

  9. 76 FR 37037 - Requirements for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and...

    Science.gov (United States)

    2011-06-24

    ... Requirements for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and Appeals and... interim final regulations published July 23, 2010 with respect to group health plans and health insurance..., group health plans, and health insurance issuers providing group health insurance coverage. The text of...

  10. 75 FR 43109 - Requirements for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and...

    Science.gov (United States)

    2010-07-23

    ... Requirements for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and Appeals and... the Office of Consumer Information and Insurance Oversight of the U.S. Department of Health and Human... health insurance coverage offered in connection with a group health plan under the Employee Retirement...

  11. 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...

  12. Claiming health in food products

    DEFF Research Database (Denmark)

    Lähteenmäki, Liisa

    2013-01-01

    Health-related information is increasingly used on food products to convey their benefits. Health claims as a subcategory of these messages link the beneficial component, functions or health outcomes with specific products. For consumers, health claims seem to carry the message of increased...... healthiness, but not necessarily making the product more appealing. The wording of the claim seems to have little impact on claim perception, yet the health image of carrier products is important. From consumer-related factors the relevance and attitudes towards functional foods play a role, whereas socio......-demographic factors have only minor impact and the impact seems to be case-dependent. Familiarity with claims and functional foods increase perceived healthiness and acceptance of these products. Apparently consumers make rather rational interpretations of claims and their benefits when forced to assess...

  13. 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…

  14. Prevalence of Nutrition and Health-Related Claims on Pre-Packaged Foods: A Five-Country Study in Europe

    Science.gov (United States)

    Hieke, Sophie; Kuljanic, Nera; Pravst, Igor; Miklavec, Krista; Kaur, Asha; Brown, Kerry A.; Egan, Bernadette M.; Pfeifer, Katja; Gracia, Azucena; Rayner, Mike

    2016-01-01

    This study is part of the research undertaken in the EU funded project CLYMBOL (“Role of health-related CLaims and sYMBOLs in consumer behaviour”). The first phase of this project consisted of mapping the prevalence of symbolic and non-symbolic nutrition and health-related claims (NHC) on foods and non-alcoholic beverages in five European countries. Pre-packaged foods and drinks were sampled based on a standardized sampling protocol, using store lists or a store floor plan. Data collection took place across five countries, in three types of stores. A total of 2034 foods and drinks were sampled and packaging information was analyzed. At least one claim was identified for 26% (95% CI (24.0%–27.9%)) of all foods and drinks sampled. Six percent of these claims were symbolic. The majority of the claims were nutrition claims (64%), followed by health claims (29%) and health-related ingredient claims (6%). The most common health claims were nutrient and other function claims (47% of all claims), followed by disease risk reduction claims (5%). Eight percent of the health claims were children’s development and health claims but these were only observed on less than 1% (0.4%–1.1%) of the foods. The category of foods for specific dietary use had the highest proportion of NHC (70% of foods carried a claim). The prevalence of symbolic and non-symbolic NHC varies across European countries and between different food categories. This study provides baseline data for policy makers and the food industry to monitor and evaluate the use of claims on food packaging. PMID:26950149

  15. Prevalence of Nutrition and Health-Related Claims on Pre-Packaged Foods: A Five-Country Study in Europe

    Directory of Open Access Journals (Sweden)

    Sophie Hieke

    2016-03-01

    Full Text Available This study is part of the research undertaken in the EU funded project CLYMBOL (“Role of health-related CLaims and sYMBOLs in consumer behaviour”. The first phase of this project consisted of mapping the prevalence of symbolic and non-symbolic nutrition and health-related claims (NHC on foods and non-alcoholic beverages in five European countries. Pre-packaged foods and drinks were sampled based on a standardized sampling protocol, using store lists or a store floor plan. Data collection took place across five countries, in three types of stores. A total of 2034 foods and drinks were sampled and packaging information was analyzed. At least one claim was identified for 26% (95% CI (24.0%–27.9% of all foods and drinks sampled. Six percent of these claims were symbolic. The majority of the claims were nutrition claims (64%, followed by health claims (29% and health-related ingredient claims (6%. The most common health claims were nutrient and other function claims (47% of all claims, followed by disease risk reduction claims (5%. Eight percent of the health claims were children’s development and health claims but these were only observed on less than 1% (0.4%–1.1% of the foods. The category of foods for specific dietary use had the highest proportion of NHC (70% of foods carried a claim. The prevalence of symbolic and non-symbolic NHC varies across European countries and between different food categories. This study provides baseline data for policy makers and the food industry to monitor and evaluate the use of claims on food packaging.

  16. Prevalence of Nutrition and Health-Related Claims on Pre-Packaged Foods: A Five-Country Study in Europe.

    Science.gov (United States)

    Hieke, Sophie; Kuljanic, Nera; Pravst, Igor; Miklavec, Krista; Kaur, Asha; Brown, Kerry A; Egan, Bernadette M; Pfeifer, Katja; Gracia, Azucena; Rayner, Mike

    2016-03-03

    This study is part of the research undertaken in the EU funded project CLYMBOL ("Role of health-related CLaims and sYMBOLs in consumer behaviour"). The first phase of this project consisted of mapping the prevalence of symbolic and non-symbolic nutrition and health-related claims (NHC) on foods and non-alcoholic beverages in five European countries. Pre-packaged foods and drinks were sampled based on a standardized sampling protocol, using store lists or a store floor plan. Data collection took place across five countries, in three types of stores. A total of 2034 foods and drinks were sampled and packaging information was analyzed. At least one claim was identified for 26% (95% CI (24.0%-27.9%)) of all foods and drinks sampled. Six percent of these claims were symbolic. The majority of the claims were nutrition claims (64%), followed by health claims (29%) and health-related ingredient claims (6%). The most common health claims were nutrient and other function claims (47% of all claims), followed by disease risk reduction claims (5%). Eight percent of the health claims were children's development and health claims but these were only observed on less than 1% (0.4%-1.1%) of the foods. The category of foods for specific dietary use had the highest proportion of NHC (70% of foods carried a claim). The prevalence of symbolic and non-symbolic NHC varies across European countries and between different food categories. This study provides baseline data for policy makers and the food industry to monitor and evaluate the use of claims on food packaging.

  17. 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....

  18. 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....

  19. 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...

  20. 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.

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

    OpenAIRE

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

    2015-01-01

    Health claims and symbols are potential aids to help consumers identify foods that are healthier options. However, little is known as to how health claims and symbols are used by consumers in real-world shopping situations, thus making the science-based formulation of new labelling policies and the evaluation of existing ones difficult. The objective of the European Union-funded project R ole of health-related?CLaims?and?sYMBOLs?in consumer behaviour (CLYMBOL) is to determine how health-relat...

  2. Health-related claims on food labels in Australia: understanding environmental health officers' roles and implications for policy.

    Science.gov (United States)

    Condon-Paoloni, Deanne; Yeatman, Heather R; Grigonis-Deane, Elizabeth

    2015-01-01

    Health and related claims on food labels can support consumer education initiatives that encourage purchase of healthier foods. A new food Standard on Nutrition, Health and Related Claims became law in January 2013. Implementation will need careful monitoring and enforcement to ensure that claims are truthful and have meaning. The current study explored factors that may impact on environmental health officers' food labelling policy enforcement practices. The study used a mixed-methods approach, using two previously validated quantitative questionnaire instruments that provided measures of the level of control that the officers exercised over their work, as well as qualitative, semi-structured, in-depth interviews. Local government; Australia. Thirty-seven officers in three Australian states participated in semi-structured in-depth interviews, as well as completing the quantitative questionnaires. Senior and junior officers, including field officers, participated in the study. The officers reported a high level of autonomy and control of their work, but also a heavy workload, dominated by concerns for public health and food safety, with limited time for monitoring food labels. Compliance of labels with proposed health claims regulations was not considered a priority. Lipsky's theory of street-level bureaucracy was used to enhance understanding of officers' work practices. Competing priorities affect environmental health officers' monitoring and enforcement of regulations. Understanding officers' work practices and their perceptions of enforcement is important to increase effectiveness of policy implementation and hence its capacity to augment education initiatives to optimize health benefits.

  3. 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.

  4. A systematic review, and meta-analyses, of the impact of health-related claims on dietary choices.

    Science.gov (United States)

    Kaur, Asha; Scarborough, Peter; Rayner, Mike

    2017-07-11

    Health-related claims are statements regarding the nutritional content of a food (nutrition claims) and/or indicate that a relationship exists between a food and a health outcome (health claims). Their impact on food purchasing or consumption decisions is unclear. This systematic review measured the effect of health-related claims, on pre-packaged foods in retail settings, on adult purchasing decisions (real and perceived). In September 2016, we searched MEDLINE, EMBASE, PsychINFO, CAB abstracts, Business Source Complete, and Web of Science/Science Citation Index & Social Science Citation Index for articles in English published in peer-review journals. Studies were included if they were controlled experiments where the experimental group(s) included a health-related claim and the control group involved an identical product without a health-related claim. Included studies measured (at an individual or population level); actual or intended choice, purchases, and/or consumption. The primary outcome was product choices and purchases, the secondary outcome was food consumption and preference. Results were standardised through calculating odds ratios and 95% confidence intervals (CI) for the likelihood of choosing a product when a health-related claim was present. Results were combined in a random-effects meta-analysis. Thirty-one papers were identified, 17 of which were included for meta-analyses. Most studies were conducted in Europe (n = 17) and the USA (n = 7). Identified studies were choice experiments that measured the likelihood of a product being chosen when a claim was present compared to when a claim was not present, (n = 16), 15 studies were experiments that measured either; intent-rating scale outcomes (n = 8), consumption (n = 6), a combination of the two (n = 1), or purchase data (n = 1). Overall, 20 studies found that claims increase purchasing and/or consumption, eight studies had mixed results, and two studies found consumption

  5. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006

    Science.gov (United States)

    Bedogni, Giorgio; Biasini, Beatrice; Zavaroni, Ivana; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Bonadonna, Riccardo C.; Passeri, Giovanni

    2018-01-01

    Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function. PMID:29443929

  6. 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.

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

    Science.gov (United States)

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

    2015-03-01

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

  8. [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.

  9. 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

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

    Science.gov (United States)

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

    2015-01-01

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

  11. 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.

  12. 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....

  13. 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.

  14. 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...

  15. 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

  16. 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...

  17. 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....

  18. 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

  19. 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...

  20. 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...

  1. 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...

  2. [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.

  3. 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.

  4. 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.

  5. 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...

  6. 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....

  7. 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.

  8. 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...

  9. 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.

  10. 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...

  11. 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...

  12. 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

  13. 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.

  14. 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...

  15. 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.

  16. 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.

  17. 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.

  18. 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...

  19. 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...

  20. 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

  1. 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...

  2. 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....

  3. 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.

  4. 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...

  5. Olive oil polyphenols: A quantitative method by high-performance liquid-chromatography-diode-array detection for their determination and the assessment of the related health claim.

    Science.gov (United States)

    Ricciutelli, Massimo; Marconi, Shara; Boarelli, Maria Chiara; Caprioli, Giovanni; Sagratini, Gianni; Ballini, Roberto; Fiorini, Dennis

    2017-01-20

    In order to assess if an extra virgin olive oil (EVOO) can be acknowledged with the health claim related to olive oil polyphenols (Reg. EU n.432/2012), a new method to quantify these species in EVOO, by means of liquid-liquid extraction followed by HPLC-DAD/MS/MS of the hydroalcoholic extract, has been developed and validated. Different extraction procedures, different types of reverse-phase analytical columns (Synergi Polar, Spherisorb ODS2 and Kinetex) and eluents have been tested. The chromatographic column Synergi Polar (250×4.6mm, 4μm), never used before in this kind of application, provided the best results, with water and methanol/isopropanol (9/1) as eluents. The method allows the quantification of the phenolic alcohols tyrosol and hydroxytyrosol, the phenolic acids vanillic, p-coumaric and ferulic acids, secoiridoids derivatives, the lignans, pinoresinol and acetoxypinoresinol and the flavonoids luteolin and apigenin. The new method has been applied to 20 commercial EVOOs belonging to two different price range categories (3.78-5.80 euros/L and 9.5-25.80 euros/L) and 5 olive oils. The obtained results highlight that acetoxypinoresinol, ferulic acid, vanillic acid and the total non secoiridoid phenolic substances resulted to be significantly higher in HEVOOs than in LEVOOs (P=0.0026, 0.0217, 0.0092, 0.0003 respectively). For most of the samples analysed there is excellent agreement between the results obtained by applying the HPLC method adopted by the International Olive Council and the results obtained by applying the presented HPLC method. Results obtained by HPLC methods have been also compared with the ones obtained by the colorimetric Folin-Ciocalteu method. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. 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...

  7. 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...

  8. 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.

  9. 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...

  10. 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...

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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...

  16. 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....

  17. 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....

  18. 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....

  19. 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....

  20. 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

  1. 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...

  2. 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

  3. 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

  4. 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...

  5. 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....

  6. 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...

  7. 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....

  8. 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....

  9. 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.

  10. 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...

  11. 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...

  12. 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...

  13. 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.

  14. 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

  15. 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...

  16. 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....

  17. 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...

  18. 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.

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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....

  5. 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....

  6. 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....

  7. 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.

  8. 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.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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....

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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.

  4. 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....

  5. 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

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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....

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. Scientific Opinion on the substantiation of a health claim related to Equazen eye q® , a combination of EPA, DHA and GLA, and improving reading ability pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2015-01-01

    Following an application from Vifor Ltd, submitted for authorisation of a health claim pursuant to Article 14 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...

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

    DEFF Research Database (Denmark)

    Tetens, Inge

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

  20. Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to sugar beet fibre and decreasing intestinal transit time pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Nordic Sugar A/S, 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 claim...

  1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to sugar beet fibre and increasing faecal bulk pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Nordic Sugar A/S, 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 claim...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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.

  8. Scientific Opinion on the substantiation of a health claim related to “native chicory inulin” and maintenance of normal defecation by increasing stool frequency pursuant to Article 13.5 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    2015-01-01

    claim related to “native chicory inulin” and maintenance of normal defecation by increasing stool frequency. The food constituent that is a subject of a claim is “native chicory inulin”. The Panel considers that “native chicory inulin”, a non-fractionated mixture of monosaccharides (...%), disaccharides, inulin-type fructans and inulin extracted from chicory, with a mean DP ≥ 9, is sufficiently characterised in relation to the claimed effect. The Panel considers that maintenance of normal defecation by increasing stool frequency (provided that it does not result in diarrhoea) is a beneficial...... physiological effect. Six studies involving 86 subjects consistently showed that consumption of “native chicory inulin” at an amount of at least 12 g/day increases stool frequency. The Panel also notes the plausible mechanisms by which inulin and inulin-type fructans in “native chicory inulin” could exert...

  9. 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....

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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....

  16. 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.

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. Scientific Opinion on the substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    2015-01-01

    Following an application from Lallemand Health Solutions, 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...... effect. The Panel considers that no conclusions can be drawn from either of the human studies for the scientific substantiation of the claim. In the absence of evidence of an effect of B. bifidum CNCM I3426 on defence against pathogens in the upper respiratory tract in humans, the results of the in vitro...... study submitted cannot be used as a source of data for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of B. bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract....

  9. 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.

  10. 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...

  11. 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....

  12. 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....

  13. 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....

  14. 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...

  15. 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”....

  16. 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....

  17. 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.

  18. 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...

  19. 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...

  20. 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.

  1. 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...

  2. 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....

  3. 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....

  4. 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...

  5. 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).

  6. 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,…

  7. 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 D? for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet pursuant to Article 13.5 of Regulation (EC) No 1924/2006

    OpenAIRE

    EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

    2015-01-01

    Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted 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 on the scientific 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 ca...

  8. 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.

  9. 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...

  10. 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...

  11. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to vitamin K2 and contribution to the normal function of the heart and blood vessels (ID 125, 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, pursuant to Article 13 of Regulation (EC) No 1924/2006, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim related to vitamin K2 and contribution to the normal function of the heart...... and blood vessels. The food constituent that is the subject of the claim, vitamin K2, is sufficiently characterised. The claimed effect, contribution to the normal function of the heart and blood vessels, is a beneficial physiological effect. The proposed target population is the general population......, that the results of two prospective cohort studies are in conflict regarding the risk of coronary heart disease associated with vitamin K2 intakes, that high intakes of vitamin K2 were associated with a significantly lower degree of aortic calcification in one prospective cohort study after adjustment...

  12. 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....

  13. 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...

  14. 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...

  15. 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....

  16. 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...

  17. 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

  18. 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...

  19. 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...

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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...

  5. 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....

  6. 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....

  7. 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.

  8. 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...

  9. 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.

  10. 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.

  11. 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...

  12. 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...

  13. 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

  14. 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.

  15. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to beta-alanine and increase in physical performance during short-duration, high-intensity exercise pursuant to Article 13(5) of Regulation (EC

    DEFF Research Database (Denmark)

    Tetens, Inge

    2014-01-01

    Following an application from Natural Alternative International, Inc. (NAI), 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 beta-alanine and increase in physical performance during short-duration, high-intensity exercise. The food constituent that is the subject of the claim is beta-alanine, which is sufficiently characterised. The Panel considers that an increase in physical...... performance during short-duration, high-intensity exercise is a beneficial physiological effect. In weighing the evidence the Panel took into account that only one out of 11 pertinent human intervention studies (including 14 pertinent outcomes) from which conclusions could be drawn showed an effect of beta...

  16. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard

    DEFF Research Database (Denmark)

    Tetens, Inge

    related to a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and protection of blood lipids from oxidative damage. The food that is the subject of the health claim, a combination...... of the following frozen vegetables: red spinach (Spinacia oleracea L.), green spinach (Spinacia oleracea L.), red chicory (Cichorium intybus L.), green chicory (Cichorium intybus L.), green leaf chard (Beta vulgaris L. var. cicla), red leaf chard (Beta vulgaris L. var. cicla), red Swiss chard (Beta vulgaris L. var...... conclusions could be drawn 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 consumption of a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf...

  17. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bicoloured” spinach and “blu savoy” cabbage and protection of blood lipids from

    DEFF Research Database (Denmark)

    Tetens, Inge

    related to a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and protection of blood lipids from oxidative damage. The food that is the subject of the health claim, a combination of Tuscan black cabbage (Brassica Oleracea botrytis L.), “tri......-coloured” Swiss chard (Beta vulgaris ciclaL.), “bi-coloured” spinach (Spinacia oleracea L.) and “blu savoy” cabbage (Brassica oleracea convar. capitata var. sabauda L.), is sufficiently characterised. The claimed effect, protection of blood lipids from oxidative damage, may be a beneficial physiological effect......-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and protection of blood lipids from oxidative damage....

  18. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard

    DEFF Research Database (Denmark)

    Tetens, Inge

    related to a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and maintenance of normal blood cholesterol concentration. The food that is the subject of the health claim, a combination of red...... spinach (Spinacia oleracea L.), green spinach (Spinacia oleracea L.), red chicory (Cichorium intybus L.), green chicory (Cichorium intybus L.), green leaf chard (Beta vulgaris L. var. cicla), red leaf chard (Beta vulgaris L. var. cicla), red Swiss chard (Beta vulgaris L. var. cicla), golden Swiss chard...... 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 consumption of a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden...

  19. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bicoloured” spinach and “blu savoy” cabbage and maintenance of normal blood LDL

    DEFF Research Database (Denmark)

    Tetens, Inge

    related to a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and maintenance of normal blood cholesterol concentration. The food that is the subject of the health claim, a combination of Tuscan black cabbage (Brassica Oleracea botrytis L.......), “tri-coloured” Swiss chard (Beta vulgaris ciclaL.), “bi-coloured” spinach (Spinacia oleracea L.) and “blu savoy” cabbage (Brassica oleracea convar. capitata var. sabauda L.), is sufficiently characterised. The claimed effect, maintenance of normal blood LDL-cholesterol concentration, is a beneficial......, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and maintenance of normal blood LDL-cholesterol concentration....

  20. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the substantiation of a health claim related to vitamin D and contribution to the normal function of the immune system pursuant to Article 14 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 vitamin D and contribution to the normal function of the immune system. The Panel considers that vitamin D is sufficiently characterised. Contribution to the normal function of the immune system is a beneficial physiological effect for children....... The Panel had previously assessed a claim on vitamin D and contribution to the normal function of the immune system with a favourable outcome. The target population was the general population. The Panel considered that vitamin D plays a regulatory role in the functioning of the immune system. The Panel...... considers that the role of vitamin D in the functioning of the immune system applies to all ages, including children. The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin D and contribution to the normal function of the immune system...

  1. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the substantiation of a health claim related to a combination of pomegranate pomace extract and greater galangal rhizome powder and an increase in the number of motile spermatozoa in semen

    DEFF Research Database (Denmark)

    Tetens, Inge

    2015-01-01

    on the scientific substantiation of a health claim related to a combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and an increase in the number of motile spermatozoa in semen. The Panel...... the combination of pomegranate pomace extract and greater galangal rhizome powder was consumed for three months, that no other human studies in which these results have been replicated were provided, and that no evidence was provided for a mechanism by which the food could exert the claimed effect. The Panel...... concludes that a cause and effect relationship has not been established between the consumption of the combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and an increase...

  2. 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....

  3. 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...

  4. 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...

  5. 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.

  6. 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.

  7. 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...

  8. 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.

  9. 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.

  10. 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.

  11. EFSA ND A Panel ( EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to eicosapentanoic acid (EPA) and “ reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the d evelopment of attention, difficulties in children with ADHD - like symptoms ” pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Minami Nutrition Health BVBA, submitted pursuant to Article 14 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 eicosapentaenoic acid (EPA) and “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with attention deficit hyperactivity disorder (ADHD)-like symptoms”. The food constituent, EPA, which is the subject...... of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less...

  12. Reducing patient drug acquisition costs can lower diabetes health claims.

    Science.gov (United States)

    Mahoney, John J

    2005-08-01

    Concerned about rising prevalence and costs of diabetes among its employees, Pitney Bowes Inc recently revamped its drug benefit design to synergize with ongoing efforts in its disease management and patient education programs. Specifically, based on a predictive model showing that low medication adherence was linked to subsequent increases in healthcare costs in patients with diabetes, the company shifted all diabetes drugs and devices from tier 2 or 3 formulary status to tier 1. The rationale was that reducing patient out-of-pocket costs would eliminate financial barriers to preventive care, and thereby increase adherence, reduce costly complications, and slow the overall rate of rising healthcare costs. This single change in pharmaceutical benefit design immediately made critical brand-name drugs available to most Pitney Bowes employees and their covered dependents for 10% coinsurance, the same coinsurance level as for generic drugs, versus the previous cost share of 25% to 50%. After 2 to 3 years, preliminary results in plan participants with diabetes indicate that medication possession rates have increased significantly, use of fixed-combination drugs has increased (possibly related to easier adherence), average total pharmacy costs have decreased by 7%, and emergency department visits have decreased by 26%. Hospital admission rates, although increasing slightly, remain below the demographically adjusted Medstat benchmark. Overall direct healthcare costs per plan participant with diabetes decreased by 6%. In addition, the rate of increase in overall per-plan-participant health costs at Pitney Bowes has slowed markedly, with net per-plan-participant costs in 2003 at about 4000 dollars per year versus 6500 dollars for the industry benchmark. This recent moderation in overall corporate health costs may be related to these strategic changes in drug benefit design for diabetes, asthma, and hypertension and also to ongoing enhancements in the company's disease

  13. 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

  14. 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...

  15. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to “hypo-caloric snacks (KOT products)” and “contributes to reduce adipocyte size at the abdominal level in the context of a low-calorie diet” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    OpenAIRE

    Tetens, Inge

    2011-01-01

    Following an application from Ceprodi KOT, 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 was asked to deliver an opinion on the scientific substantiation of a health claim related to “hypo-caloric snacks (KOT products)” and “contributes to reduce adipocyte size at the abdominal level in the context of a low-calorie diet”. The target population is overweight individuals who wish...

  16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of defence against pathogenic gastrointestinal microorganisms pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    consumption on the stimulation of protective immune responses after oral (viral) vaccination and, in the absence of evidence for an effect of LGG consumption on the development of GI infections in the general population, studies on the treatment of GI infections, on diarrhoea during antibiotic use......Following an application from Valio Ltd., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related...

  17. European Food Safety Authority; Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to beta-palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following a request from the European Commission, EFSA was asked to review the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to beta-palmitate and increased...... calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from the applicant (IDACE). EFSA has reviewed the comments and shared them with the chair of the NDA Panel, Prof. Albert Flynn, and the chair of the NDA...

  18. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic

    DEFF Research Database (Denmark)

    Tetens, Inge

    2014-01-01

    on the scientific substantiation of a health claim related to a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic responses. The Panel considers that the food is sufficiently characterised. The target population proposed...... not been established between the consumption of the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, and a beneficial physiological effect for the target population....

  19. 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.

  20. 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...

  1. 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.

  2. What makes health public?: a critical evaluation of moral, legal, and political claims in public health

    National Research Council Canada - National Science Library

    Coggon, John

    2012-01-01

    .... Covering important works from legal, moral, and political theory, public health, public health law and ethics, and bioethics, this is a foundational text for scholars, practitioners and policy bodies interested in freedoms, rights and responsibilities relating to health"--

  3. 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

  4. 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.

  5. 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....

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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...

  11. 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...

  12. 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....

  13. 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...

  14. 21 CFR 101.70 - Petitions for health claims.

    Science.gov (United States)

    2010-04-01

    ... contact the Center for Food Safety and Applied Nutrition for details.) If any part of the material... articles, National Institutes of Health consensus development conferences, and other appropriate resource... computer literature searches done by the petitioner (e.g., Medline). 2. Copies of articles cited in the...

  15. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to phaseolamine and reduction in body weight (ID 1701) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    as reservoir fats if not immediately utilised by the organism; it results in a lower calories intake, contributing to weight loss”. The target population is assumed to be overweight individuals in the general population who wish to reduce their body weight. In the context of the proposed wordings, the Panel...... assumes that the claimed effect refers to a reduction in body weight. The Panel considers that reduction in body weight is a beneficial physiological effect. In weighing the evidence, the Panel took into account that although one short-term (30 day) intervention study in humans showed an effect...

  16. Kombucha, the fermented tea: microbiology, composition, and claimed health effects.

    Science.gov (United States)

    Greenwalt, C J; Steinkraus, K H; Ledford, R A

    2000-07-01

    Kombucha is a slightly sweet, slightly acidic tea beverage consumed worldwide, but historically in China, Russia, and Germany. Kombucha is prepared by fermenting sweetened black tea preparations with a symbiotic culture of yeasts and bacteria. Potential health effects have created an increased interest in Kombucha. Yet, only a few research studies have shown that Kombucha has in vitro antimicrobial activity and enhances sleep and pain thresholds in rats. Furthermore, Kombucha consumption has proven to be harmful in several documented instances.

  17. 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.

  18. 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

  19. 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...

  20. Black pepper and health claims: a comprehensive treatise.

    Science.gov (United States)

    Butt, Masood Sadiq; Pasha, Imran; Sultan, Muhammad Tauseef; Randhawa, Muhammad Atif; Saeed, Farhan; Ahmed, Waqas

    2013-01-01

    For millennia, spices have been an integral part of human diets and commerce. Recently, the widespread recognition of diet-health linkages bolsters their dietary importance. The bioactive components present in them are of considerable significance owing to their therapeutic potential against various ailments. They provide physiological benefits or prevent chronic ailment in addition to the fundamental nutrition and often included in the category of functional foods. Black pepper (Piper Nigrum L.) is an important healthy food owing to its antioxidant, antimicrobial potential and gastro-protective modules. Black pepper, with piperine as an active ingredient, holds rich phytochemistry that also includes volatile oil, oleoresins, and alkaloids. More recently, cell-culture studies and animal modeling predicted the role of black pepper against number of maladies. The free-radical scavenging activity of black pepper and its active ingredients might be helpful in chemoprevention and controlling progression of tumor growth. Additionally, the key alkaloid components of Piper Nigrum, that is, piperine assist in cognitive brain functioning, boost nutrient's absorption and improve gastrointestinal functionality. In this comprehensive treatise, efforts are made to elucidate the antioxidant, antimicrobial, anti-inflammatory, gastro-protective, and antidepressant activities of black pepper. Moreover, the synergistic interaction of black pepper with different drugs and nutrients is the limelight of the manuscript. However, the aforementioned health-promoting benefits associated with black pepper are proven in animal modeling. Thus, there is a need to conduct controlled randomized trials in human subjects, cohort studies, and meta-analyses. Such future studies would be helpful in recommending its application in diet-based regimens to prevent various ailments.

  1. 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

  2. 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.

  3. 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.

  4. 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…

  5. 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...

  6. 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

  7. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to polyphenols in olive and maintenance of normal blood HDL-cholesterol concentrations (ID 1639, further assessment) pursuant to Article 13(1) of Regulation (EC

    DEFF Research Database (Denmark)

    Tetens, Inge

    and maintenance of normal blood HDL-cholesterol concentrations. The food constituent, polyphenols in olive (olive fruit, olive mill waste waters or olive oil, Olea europaea L. extract and leaf) standardised by their content of hydroxytyrosol and its derivatives (e.g. oleuropein complex), that is the subject...... was insufficient to establish a cause and effect relationship between the consumption of olive oil polyphenols (standardised by the content of hydroxytyrosol and its derivatives) and maintenance of normal blood HDL cholesterol concentrations.......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on a health claim pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to polyphenols in olive...

  8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to isoleucyl-prolyl-proline (IPP) and valyl-prolyl-proline (VPP) and maintenance of normal blood pressure pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    to isoleucyl-prolyl-proline (IPP) and valyl-prolyl-proline (VPP) and maintenance of normal blood pressure (BP). The tripeptides IPP and VPP are sufficiently characterised. Maintenance of normal blood pressure is a beneficial physiological effect. The applicant identified a total of 20 published intervention......Following an application from Valio Ltd submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related...... relationship has not been established between the consumption of IPP and VPP and maintenance of normal blood pressure. © European Food Safety Authority, 2011...

  9. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to isoleucine-proline-proline (IPP) and valine-proline-proline (VPP) and maintenance of normal blood pressure (ID 661, 1831, 1832, 2891, further assessment) pursuant

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following a request from the European Commission, pursuant to Article 13.1 of Regulation (EC) No 1924/2006, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim related to isoleucine-proline-proline (IPP) and valine-proline-proline (VPP....... The proposed target population is the general population. In weighing the evidence, the Panel took into account that 15 of the human intervention studies provided, of which seven were adequately powered to detect small between-group differences in systolic blood pressure, did not observe an effect of IPP...... and VPP on systolic blood pressure or diastolic blood pressure; that interpretation of the results from nine out of the ten studies which reported an effect of IPP and VPP on office systolic blood pressure was limited by methodological weaknesses; that the animal and in vitro/ex vivo studies did...

  10. 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.

  11. 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...

  12. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract pursuant

    DEFF Research Database (Denmark)

    Tetens, Inge

    related to CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract. The food that is the subject of the claim is CranMax®. The Panel considers that the food, CranMax®, which is the subject of the claim is sufficiently characterised...... in relation to the claimed effect. The Panel considers that reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract is a beneficial physiological effect. One human study from which conclusions could be drawn for the scientific substantiation...... of the claim did not show an effect of CranMax® on reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract. The Panel concludes that a cause and effect relationship has not been established between the consumption of CranMax® and reduction...

  13. 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

  14. 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

  15. 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.

  16. 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 ...

  17. 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.

  18. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to diacylglycerol (DAG) oil and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    claim related to diacylglycerol oil and reduction of body weight. The food constituent, diacylglycerol (DAG) oil, and the food constituents, vegetable oils of similar fatty acid composition containing mostly (>90%) triacylglycerol (TAG), which DAG oil should replace in order to obtain the claimed effect...... conclusions to be drawn for the scientific substantiation of the claim. The results from six RCTs with respect to the effect of DAG oil (as a replacement of TAG oils) on body weight are inconsistent and apparently unrelated to the DAG dose, study size or study duration, and the evidence provided in support...... of mechanisms by which DAG oil could exert the claimed effect in humans under the proposed conditions of use is not convincing. One unpublished meta-analysis on the effects of DAG oil (as compared to TAG oils) on body weight in humans which included data from all these RCTs was also provided. The meta...

  19. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to glucosamine 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 Béres Pharmaceuticals Ltd., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health...

  20. 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

  1. 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...

  2. 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

  3. EFSA Panel on Diet etic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to krill oil and maintenance of joint comfort 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 was asked to deliver an opinion on the scientific substantiation of a health claim...

  4. Scientific Opinion on the substantiation of a health claim related to Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No

    DEFF Research Database (Denmark)

    Tetens, Inge

    2015-01-01

    Following an application from Avesthagen Limited, 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 th...

  5. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Rhodiola rosea L. extract and reduction of mental fatigue 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...

  6. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to “Femilub” and maintenance of vaginal moisture pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Nutrilinks Sarl 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion...

  7. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to choline and “development of brain” pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    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...

  8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

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

  9. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to DHA and contribution to normal brain development pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from DSM Nutritional Products, submitted for authorisation of a health claim pursuant to Article 14 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...

  10. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to hyaluronic acid 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 Nutrilinks Sarl, 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

  11. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to “complex carbohydrates” and “contribute to satiety” pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    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...

  12. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Slendesta® Potato Extract and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 19 24/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Kemin Foods LC, 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

  13. 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 concentrations of triglycerides pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Nutrilinks Sarl, 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

  14. 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...

  15. 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.

  16. 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.

  17. Scientific Opinion on the substantiation of health claims related to Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms (ID 913, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    . boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms. The food constituent that is the subject of the health claim, Saccharomyces cerevisiae var. boulardii CNCM I-1079, is sufficiently characterised. The claimed effect, defence against pathogenic gastro......-intestinal microorganisms, is a beneficial physiological effect. The proposed target population is the general population. The Panel notes that the evidence provided is not sufficient to establish that the strains Saccharomyces cerevisiae var. boulardii CNCM I-1079 and Saccharomyces cerevisiae var. boulardii Hansen CBS...... relationship has not been established between the consumption of Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms....

  18. 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.

  19. 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.

  20. 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...

  1. 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.

  2. 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...

  3. 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.

  4. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to very low calorie diets (VLCDs) and reduction in body weight (ID 1410), reduction in the sense of hunger (ID 1411), reduction in body fat mass while maintaining lean

    DEFF Research Database (Denmark)

    Tetens, Inge

    claims in relation to very low calorie diets (VLCDs) and reduction in body weight, reduction in the sense of hunger, reduction in body fat mass while maintaining lean body mass, reduction of post-prandial glycaemic responses, and maintenance of normal blood lipid profile. The scientific substantiation...... that whereas the diet that is the subject of the claim, very low calorie diet, is sufficiently characterised in relation to the following claimed effects: reduction in body weight (ID 1410), reduction in the sense of hunger (ID 1411), and reduction in body fat mass while maintaining lean body mass (ID 1412...... that formula foods for use in very low calorie diets should contain. The Panel concludes that a cause and effect relationship cannot be established between the consumption of a very low calorie diet and reduction of post-prandial glycaemic responses (ID 1414) and maintenance of normal blood lipid profile (ID...

  5. 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.

  6. 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

  7. Is the hype around the reproductive health claims of maca (Lepidium meyenii Walp.) justified?

    Science.gov (United States)

    Beharry, Shruti; Heinrich, Michael

    2018-01-30

    Maca - Lepidium meyenii Walp. has been cultivated and used by Andean people for over 1300-2000 years in Peru as food and medicine. Starting in the late 1990's it has developed into an important herbal medicine in China and is now cultivated there widely, too AIM OF STUDY: This study aims to provide an insight into the emergence of maca on the global market as an alternative remedy to treat reproductive health related problems in both men and women and to critically assess these health claims. A search of electronic databases such as EMBASE and a hand-search was done to acquire peer-reviewed articles and reports about maca. Lepidium meyenii is used traditionally as a tonic, fertility enhancer for both humans and cattle, and to treat a variety of ailments such as rheumatism, respiratory disorders and anaemia among others. Maca root is cooked, baked, fermented as a drink and made into porridge. In the last twenty years, maca was introduced onto the global market and demand has dramatically grown over this time with its promotion on the internet, as the 'Peruvian Ginseng' for libido and fertility enhancement. It has also been said to treat menopausal symptoms, erectile dysfunction and benign prostatic hyperplasia. The sky-rocketing demand for the plant has seen a shift from traditional cultivation methods to mass production practices with the use of fertilisers and also pesticides; as maca is now grown in areas other than the Andes such as in the Yunnan province in China. This can potentially affect the phytochemistry and composition of the plant and thus, the quality, safety and efficacy of maca products. Meanwhile, research into maca's medicinal properties has followed the spike in popularity of maca and has been focused mainly on maca's aphrodisiac and fertility enhancing properties. So far, the in vivo studies and clinical trials conducted have yielded inconclusive results. Some of the key limitations reside in methodology and sample size. Chemical profiling, led

  8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to capsaicin and maintenance of body weight after weight loss (ID 2039, 2041, 2042), increase in carbohydrate oxidation (ID 2040), and contribution to normal hair growth

    DEFF Research Database (Denmark)

    Tetens, Inge

    claims in relation to capsaicin and contribution to the maintenance or achievement of a normal body weight, increase in carbohydrate oxidation, and contribution to normal hair growth. The scientific substantiation is based on the information provided by the Member States in the consolidated list...

  9. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to astaxanthin and protection of the skin from UV-induced damage (ID 1687, 1979), defence against Helicobacter pylori (ID 1686), contribution to normal spermatogenesis

    DEFF Research Database (Denmark)

    Tetens, Inge

    claims in relation to astaxanthin and protection of the skin from UV-induced damage, defence against Helicobacter pylori, contribution to normal spermatogenesis, contribution to normal muscle function, and “immune system”. The scientific substantiation is based on the information provided by the Member...

  10. 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...

  11. Claiming territory: medical mission, interreligious revivalism, and the spatialization of health interventions in urban Tanzania.

    Science.gov (United States)

    Dilger, Hansjörg

    2014-01-01

    Over the past decades, new religious actors have become involved in the provision of medical care in urban Tanzania. Muslim revivalist organizations and neo-Pentecostal churches in particular have established a range of health interventions that are tied to revisionist claims about religion, spirituality, and politics in society. In this article I discuss medical mission in Dar es Salaam in the light of (post)colonial histories of health service provision as well as with regard to inter- and intradenominational contestations over health and well-being, a morally acceptable life, and political participation. I argue that the nature of the inscription of revivalist organizations in urban space through health interventions depends on their structural location and their respective members' social and economic capital. I also show that the ongoing transformations of urban space through medical mission have become reflective of, as well as are triggering, moral interpretations of history and social inequality in contemporary Tanzania.

  12. 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.

  13. 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'.

  14. 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.

  15. 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...

  16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to L-tyrosine and contribution to normal synthesis of dopamine pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Vitabiotics Ltd. 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 was asked to deliver an opinion on the scientific substantiation of a health claim...... relationship has been established between the consumption of L-tyrosine in a protein adequate diet and contribution to normal synthesis of dopamine. However, no evidence has been provided that the protein supply in the diet of the European population is not sufficient to fulfil this function of the amino acid....... The following wording reflects the scientific evidence: “L-tyrosine contributes to normal synthesis of dopamine”. In order to bear the claim a food should be at least a source of protein as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target...

  17. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 20 13 . Scientific Opinion on the substantiatio n of a health claim related to iron and contribution to normal cognitive development pursuant to Article 14 of Regulation (EC ) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    to iron and contribution to normal cognitive development. The food constituent, iron, which is the subject of the health claim, is sufficiently characterised. Contribution to normal cognitive development is a beneficial physiological effect for infants and young children. A claim on iron and cognitive...... development in children (up to 18 years) has already been assessed with a favourable outcome. The Panel notes that the role of iron in normal cognitive development also applies to infants and young children (from birth to three years). The Panel concludes that a cause and effect relationship has been...... established between dietary intake of iron and contribution to normal cognitive development. The following wording reflects the scientific evidence: “Iron contributes to normal cognitive development”. The target population is infants and children up to three years. © European Food Safety Authority, 2013...

  18. 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 carbohydrates 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 Beneo-Orafti SA, Sensus BV and Cosucra-Groupe Warcoing SA, 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...... not contribute to post-prandial glycaemia. 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......-prandial glycaemic responses might be a beneficial physiological effect. In weighing the evidence, the Panel took into account that consumption of non-digestible carbohydrates results in reduced post-prandial blood glucose (and insulinaemic) responses compared with the consumption of sugars on a weight...

  19. 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.

  20. Health Care Service Utilization of Dementia Patients before and after Institutionalization: A Claims Data Analysis

    Directory of Open Access Journals (Sweden)

    Larissa Schwarzkopf

    2014-06-01

    Full Text Available Background: Community-based and institutional dementia care has been compared in cross-sectional studies, but longitudinal information on the effect of institutionalization on health care service utilization is sparse. Methods: We analyzed claims data from 651 dementia patients via Generalized Estimation Equations to assess health care service utilization profiles and corresponding expenditures from four quarters before to four quarters after institutionalization. Results: In all domains, utilization increased in the quarter of institutionalization. Afterwards, the use of drugs, medical aids, and non-physician services (e.g., occupational therapy and physiotherapy remained elevated, but use of in- and outpatient treatment decreased. Cost of care showed corresponding profiles. Conclusion: Institutional dementia care seems to be associated with an increased demand for supportive services but not necessarily for specialized medical care.

  1. 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.

  2. 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.

  3. Expectations in the field of the internet and health: an analysis of claims about social networking sites in clinical literature.

    Science.gov (United States)

    Koteyko, Nelya; Hunt, Daniel; Gunter, Barrie

    2015-03-01

    This article adopts a critical sociological perspective to examine the expectations surrounding the uses of social networking sites (SNSs) articulated in the domain of clinical literature. This emerging body of articles and commentaries responds to the recent significant growth in SNS use, and constitutes a venue in which the meanings of SNSs and their relation to health are negotiated. Our analysis indicates how clinical writing configures the role of SNSs in health care through a range of metaphorical constructions that frame SNSs as a tool, a conduit for information and a traversable space. The use of such metaphors serves not only to describe the new affordances offered by SNSs but also posits distinct lay and professional practices, while reviving a range of celebratory claims about the Internet and health critiqued in sociological literature. These metaphorical descriptions characterise SNS content as essentially controllable by autonomous users while reiterating existing arguments that e-health is both inherently empowering and risky. Our analysis calls for a close attention to these understandings of SNSs as they have the potential to shape future online initiatives, most notably by anticipating successful professional interventions while marginalising the factors that influence users' online and offline practices and contexts. © 2015 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for Sociology of Health & Illness.

  4. 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.

  5. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to Lactobacillus paracasei LPC 01 (CNCM I-1390) and treatment of disease (ID 3055, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    paracasei LPC 01 (CNCM I-1390) and treatment of disease. The food constituent, L. paracasei LPC 01 (CNCM I-1390), is sufficiently characterised. The claimed effect proposed for further assessment is “relieve symptoms typically associated with Irritable Bowel Syndrome (IBS), especially diarrhoea......”. The Panel considers that the claimed effect is related to the treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.......-predominant IBS, and to help reduce the daily number of bowel movements as well as improve the consistency of faeces in adult subjects reporting acute diarrhoea”. The proposed target population is “adults suffering either from Irritable Bowel Syndrome, especially diarrhoea-predominant IBS, or from acute diarrhoea...

  6. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced (including photo-oxidative) damage pursuant to Article 13

    DEFF Research Database (Denmark)

    Tetens, Inge

    related to a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced (including photo-oxidative) damage. The Panel considers that the combination of lycopene, vitamin E, lutein and selenium is sufficiently characterised. The claimed effect refers to the photo...... could 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 a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced (including......-protective activity of the food, delaying the appearance of UV-induced erythema and decreasing its intensity. The target population proposed by the applicant is healthy adults in the general population, and in particular people with sensitive skin. The Panel considers that protection of the skin from UV...

  7. 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.

  8. The indoor UV tanning industry: a review of skin cancer risk, health benefit claims, and regulation.

    Science.gov (United States)

    Levine, Jody A; Sorace, Michael; Spencer, James; Siegel, Daniel M

    2005-12-01

    Nearly 30 million people tan indoors in the United States annually, including 2.3 million adolescents. Despite increased evidence on the dangers of artificial UV radiation, the popularity of indoor tanning is growing. We aim to assess the following 3 entities: (1) the association of indoor tanning with skin cancer; (2) statements regarding the health benefits of indoor tanning, especially regarding the production of vitamin D; and (3) current regulation of the tanning industry in the United States. We conducted a narrative review of the literature. Indoor tanning poses great risks. Studies support the role of artificial UV radiation in cutaneous carcinogenesis. Despite claims by the tanning industry, artificial tanning is not a safe or necessary way to increase systemic vitamin D levels. The National Institutes of Health and the World Health Organization have acknowledged the risks of indoor tanning. Nonetheless, regulations limiting tanning in the United States are surprisingly sparse. Systematic review of the literature was not performed. Health care providers must increase efforts to warn and educate the public and government about the dangers of UV radiation.

  9. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    2015-01-01

    Following an application from Han-Asiabiotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 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...... in blood pressure when Symbiosal® was consumed instead of table salt for eight weeks in the context of a salt-restricted diet, but that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study...

  10. A Clinical Data Warehouse Based on OMOP and i2b2 for Austrian Health Claims Data.

    Science.gov (United States)

    Rinner, Christoph; Gezgin, Deniz; Wendl, Christopher; Gall, Walter

    2018-01-01

    To develop simulation models for healthcare related questions clinical data can be reused. Develop a clinical data warehouse to harmonize different data sources in a standardized manner and get a reproducible interface for clinical data reuse. The Kimball life cycle for the development of data warehouse was used. The development is split into the technical, the data and the business intelligence pathway. Sample data was persisted in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The i2b2 clinical data warehouse tools were used to query the OMOP CDM by applying the new i2b2 multi-fact table feature. A clinical data warehouse was set up and sample data, data dimensions and ontologies for Austrian health claims data were created. The ability of the standardized data access layer to create and apply simulation models will be evaluated next.

  11. 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.

  12. The legitimacy of raising aquilian claim in the case of destruction of an obligation relation object

    Directory of Open Access Journals (Sweden)

    Aličić Samir

    2011-01-01

    Full Text Available If an object which should be submitted on the basis of obligation is unlawfully destroyed, Aquilian claim belongs to the debtor as the owner of the object, regardless of whether it was destroyed by a creditor or a third party, and the debtor is relieved of the obligation. The claim does not belong to him only if the creditor destroys the object while the debtor is delayed, or if a third party destroys the object with the intent to harm the creditor. In the latter case, actio doli belongs to the creditor. Also in cases in which he was denied Aquilian claim, the debtor is freed from liability obligations, if the destroyed object was individually determined. Aquilian claim also belongs to the debtor in case of damage to the object which should be submitted, but if the object is damaged by a third party, the creditor is entitled to require from the debtor Aquilian claim to be left to him. If the detentor destroys or damages the object he that keeps under contract , the creditor can sue him with contract suit or suit for unlawful damage. And if the object is destroyed by a third party, Aquilian claim on the value of the object belongs exclusively to the creditor as the owner of the object, while the detentor can only have the right to Aquilian claim on the value of results of the object, as their owner.

  13. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum with pyro- and triphosphates and reduction of calculus formation (ID 1309) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    calculus/tartar formation, gums health”. The target population is assumed to be the general population. The Panel considers that reduction of calculus formation at sites which are most important for dental health is a beneficial physiological effect. No human studies have been provided from which...... conclusions could be drawn for the scientific substantiation of a claim on the use of sugar-free chewing gum with pyro- and triphosphates and the reduction of calculus formation at sites which are most important for dental health (e.g. gingival margin or between teeth). On the basis of the data presented......, the Panel concludes that a cause and effect relationship has not been established between the use of sugar-free chewing gum with pyro- and triphosphates and reduction of calculus formation at sites which are most important for dental health....

  14. Claim Your Space: Leadership Development as a Research Capacity Building Goal in Global Health.

    Science.gov (United States)

    Airhihenbuwa, Collins O; Ogedegbe, Gbenga; Iwelunmor, Juliet; Jean-Louis, Girardin; Williams, Natasha; Zizi, Freddy; Okuyemi, Kolawole

    2016-04-01

    As the burden of noncommunicable diseases (NCDs) rises in settings with an equally high burden of infectious diseases in the Global South, a new sense of urgency has developed around research capacity building to promote more effective and sustainable public health and health care systems. In 2010, NCDs accounted for more than 2.06 million deaths in sub-Saharan Africa. Available evidence suggests that the number of people in sub-Saharan Africa with hypertension, a major risk factor for cardiovascular diseases, will increase by 68% from 75 million in 2008 to 126 million in 2025. Furthermore, about 27.5 million people currently live with diabetes in Africa, and it is estimated that 49.7 million people living with diabetes will reside in Africa by 2030. It is therefore necessary to centralize leadership as a key aspect of research capacity building and strengthening in the Global South in ways that enables researchers to claim their spaces in their own locations. We believe that building capacity for transformative leadership in research will lead to the development of effective and appropriate responses to the multiple burdens of NCDs that coexist with infectious diseases in Africa and the rest of the Global South. © 2016 Society for Public Health Education.

  15. 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

  16. Expectations in the field of the Internet and health: an analysis of claims about social networking sites in clinical literature

    Science.gov (United States)

    Koteyko, Nelya; Hunt, Daniel; Gunter, Barrie

    2015-01-01

    This article adopts a critical sociological perspective to examine the expectations surrounding the uses of social networking sites (SNSs) articulated in the domain of clinical literature. This emerging body of articles and commentaries responds to the recent significant growth in SNS use, and constitutes a venue in which the meanings of SNSs and their relation to health are negotiated. Our analysis indicates how clinical writing configures the role of SNSs in health care through a range of metaphorical constructions that frame SNSs as a tool, a conduit for information and a traversable space. The use of such metaphors serves not only to describe the new affordances offered by SNSs but also posits distinct lay and professional practices, while reviving a range of celebratory claims about the Internet and health critiqued in sociological literature. These metaphorical descriptions characterise SNS content as essentially controllable by autonomous users while reiterating existing arguments that e-health is both inherently empowering and risky. Our analysis calls for a close attention to these understandings of SNSs as they have the potential to shape future online initiatives, most notably by anticipating successful professional interventions while marginalising the factors that influence users’ online and offline practices and contexts. PMID:25847533

  17. 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...

  18. 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...

  19. 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...

  20. The interplay of health claims and taste importance on food consumption and self-reported satiety.

    Science.gov (United States)

    Vadiveloo, Maya; Morwitz, Vicki; Chandon, Pierre

    2013-12-01

    Research has shown that subtle health claims used by food marketers influence pre-intake expectations, but no study has examined how they influence individuals' post-consumption experience of satiety after a complete meal and how this varies according to the value placed on food taste. In two experiments, we assess how labeling a pasta salad as "healthy" or "hearty" influences self-reported satiety, consumption volume, and subsequent consumption of another food. Using MANOVA, Study 1 shows that individuals who report low taste importance consume less-yet feel just as satiated-when a salad is labeled "hearty" rather than "healthy." In contrast, for individuals with higher taste importance, consumption and self-reported satiety are correlated and are both higher when a salad is labeled as "hearty" versus "healthy." Study 2 primes taste importance, rather than measuring it, and replicates these findings for consumption, but not for self-reported satiety. There was no effect on the consumption of other foods in either study. Overall, our findings add to earlier work on the impact of health labels by showing that subtle food descriptions also influence post-intake experiences of satiety, but that the direction of the effects depends on taste importance and on the selection of direct or indirect measures of satiety. Copyright © 2013 Elsevier Ltd. All rights reserved.

  1. 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.

  2. 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...

  3. 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...

  4. Scientific Method and the Regulation of Health and Nutritional Claims by the European Food Safety Authority

    Science.gov (United States)

    Hoad, Darren

    2011-01-01

    The protection of European consumers from the false or misleading scientific and nutritional claims of food manufacturers took a step forward with the recent opinions of the European Food Safety Authority (EFSA). As a risk assessment agency, the EFSA recently assessed and rejected a vast number of food claim forcing the withdrawal of many claims…

  5. 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.

  6. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater, reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from McNeil Nutritionals and Raisio Nutrition Ltd, submitted for authorisation of a health claim pursuant to Article 14 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 the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low...... an evaluation of the quantitative effects of diets low in saturated fat per se on blood LDL-cholesterol concentrations. Therefore, the effect of consuming 2 g/day plant stanols as part of a diet low in saturated fat relative to the effect of consuming a diet low in saturated fat alone cannot be determined...

  7. 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".

  8. Health insurance and the demand for medical care: Instrumental variable estimates using health insurer claims data.

    Science.gov (United States)

    Dunn, Abe

    2016-07-01

    This paper takes a different approach to estimating demand for medical care that uses the negotiated prices between insurers and providers as an instrument. The instrument is viewed as a textbook "cost shifting" instrument that impacts plan offerings, but is unobserved by consumers. The paper finds a price elasticity of demand of around -0.20, matching the elasticity found in the RAND Health Insurance Experiment. The paper also studies within-market variation in demand for prescription drugs and other medical care services and obtains comparable price elasticity estimates. Published by Elsevier B.V.

  9. 21 CFR 101.65 - Implied nutrient content claims and related label statements.

    Science.gov (United States)

    2010-04-01

    ..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food...., “as much fiber as an apple,” “Contains the same amount of Vitamin C as an 8 oz glass of orange juice... that is useful in creating a diet that is consistent with dietary recommendations if: (i) The food...

  10. 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.

  11. 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.

  12. 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.

  13. PS2-15: Coding for Obesity in a Health Plan Claims Database

    OpenAIRE

    Shainline, Michael; Carter, Shelley; Von Worley, Ann; Gunter, Margaret

    2010-01-01

    Background and Aims: The Centers for Disease Control estimated the obesity rate in New Mexico for 2008 to be 25.2%. Sources estimate the following associations between obesity and type 2 diabetes (80%); cardiovascular disease (70%); hypertension (26 %). Yet obesity is infrequently coded as a secondary diagnosis among providers submitting claims. This study examines the frequency with which obesity is documented on claims forms, the relationship between age, gender, and obesity coding, and the...

  14. Philippines – China Relations: The Case of the South China Sea (Spratly Islands Claims

    Directory of Open Access Journals (Sweden)

    Mark Anthony M. Velasco

    2014-12-01

    Full Text Available The research is focused on examining by describing historically the relationship between the Philippines and China in the disputed claims over the islands in South China Sea. To crystalize this goal, the discourse in the paper heavily employs inter-textual analysis that is logically arranged into an opening idea on the context of the conflicting issue over the islands situated in Spratlys, then followed by an extensive illustration of the relationship between the Philippines and China concerning the territorial claims over the islands of South China Sea. Subsequently, a brief reflection guided by the principle of territoriality is portrayed with the goal to authoritatively explain the idea of jurisdiction over the islands in the Spratly area. After that, the paper briefly concludes with a prospectus on the issue of South China Sea.

  15. Violence related to health work

    OpenAIRE

    Juliana da Silva Oliveira; Roberta Laíse Gomes Leite Morais; Elisama Nascimento Rocha; Sérgio Donha Yarid; Edite Lago da Silva Sena; Rita Narriman Silva de Oliveira Boery

    2014-01-01

    This study aimed to present a critical and reflective literature review on the violence related to health work. The survey was conducted through an integrated search in the Virtual Health Library in the months of May and June 2011. We selected 24 articles. The reading of the material led us to the following division results: studies characterization and bioethical reflection on violence related to health work. The work-related violence has consequences not only direct on ...

  16. The contribution of bone scintigraphy in occupational health or medical insurance claims: a retrospective study

    Energy Technology Data Exchange (ETDEWEB)

    Versijpt, J.; Dierckx, R.A.; Bondt, P. de [Division of Nuclear Medicine, University Hospital Gent (Belgium); Dierckx, I. [Department of Radiology, St. Elisabeth Hospital Antwerpen (Belgium); Lambrecht, L. [Outpatient Internal Medicine Clinic, Gent (Belgium); Sadeleer, C. de [Division of Nuclear Medicine, University Hospital Gent (Belgium)]|[Department of Nuclear Medicine, O.L.V. Hospital Geraardsbergen (Belgium)

    1999-08-01

    Patients with a suspicion of bone damage following an industrial or traffic accident are often referred for bone scintigraphy as part of an occupational health or medical insurance investigation. The aim of this study was to assess the contribution and the potential role of bone scintigraphy compared with X-ray investigations in the aforementioned situation. To this end we evaluated 70 consecutive patients referred for bone scintigraphy during 1996 and 1997 by occupational health or medical insurance physicians. The most common reasons for referral were the exclusion of occult fractures of hands and feet, whiplash injuries, reflex sympathetic dystrophy or avascular necrosis, or the differentiation between an old and a recent vertebral fracture. X-rays were only available for comparative review of 53 patients, so only those were analysed. The results of bone scintigraphy were compared with X-rays, and their contribution and potential role in occupational health or medical insurance investigations assessed. In 31 out of the 53 patients investigated, bone scintigraphy findings concurred with X-rays as to the number and location of abnormalities. For 19 of the 53 patients, bone scintigraphy showed clinically relevant additional foci when compared with X-rays, predominantly involving lesions to hands/wrists and feet/ankles. Among these 19 patients, scintigraphic diagnoses were subsequently confirmed in ten cases by means of X-ray or computed tomography. In four patients, supplementary radiological investigations revealed no abnormalities, and in five patients no further investigations were undertaken. Finally, in three of the 53 patients, X-rays revealed bone damage (burst fractures) whilst the corresponding bone scintigraphy was negative, thus excluding recent injury. In conclusion, in 22 patients, representing 42% of the cases analysed, bone scintigraphy was conclusive compared with X-ray imaging in the final diagnosis and in this way in detecting occult or excluding

  17. The contribution of bone scintigraphy in occupational health or medical insurance claims: a retrospective study

    International Nuclear Information System (INIS)

    Versijpt, J.; Dierckx, R.A.; Bondt, P. de; Dierckx, I.; Lambrecht, L.; Sadeleer, C. de

    1999-01-01

    Patients with a suspicion of bone damage following an industrial or traffic accident are often referred for bone scintigraphy as part of an occupational health or medical insurance investigation. The aim of this study was to assess the contribution and the potential role of bone scintigraphy compared with X-ray investigations in the aforementioned situation. To this end we evaluated 70 consecutive patients referred for bone scintigraphy during 1996 and 1997 by occupational health or medical insurance physicians. The most common reasons for referral were the exclusion of occult fractures of hands and feet, whiplash injuries, reflex sympathetic dystrophy or avascular necrosis, or the differentiation between an old and a recent vertebral fracture. X-rays were only available for comparative review of 53 patients, so only those were analysed. The results of bone scintigraphy were compared with X-rays, and their contribution and potential role in occupational health or medical insurance investigations assessed. In 31 out of the 53 patients investigated, bone scintigraphy findings concurred with X-rays as to the number and location of abnormalities. For 19 of the 53 patients, bone scintigraphy showed clinically relevant additional foci when compared with X-rays, predominantly involving lesions to hands/wrists and feet/ankles. Among these 19 patients, scintigraphic diagnoses were subsequently confirmed in ten cases by means of X-ray or computed tomography. In four patients, supplementary radiological investigations revealed no abnormalities, and in five patients no further investigations were undertaken. Finally, in three of the 53 patients, X-rays revealed bone damage (burst fractures) whilst the corresponding bone scintigraphy was negative, thus excluding recent injury. In conclusion, in 22 patients, representing 42% of the cases analysed, bone scintigraphy was conclusive compared with X-ray imaging in the final diagnosis and in this way in detecting occult or excluding

  18. Comparison of Medicare claims versus physician adjudication for identifying stroke outcomes in the Women's Health Initiative.

    Science.gov (United States)

    Lakshminarayan, Kamakshi; Larson, Joseph C; Virnig, Beth; Fuller, Candace; Allen, Norrina Bai; Limacher, Marian; Winkelmayer, Wolfgang C; Safford, Monika M; Burwen, Dale R

    2014-03-01

    Many studies use medical record review for ascertaining outcomes. One large, longitudinal study, the Women's Health Initiative (WHI), ascertains strokes using participant self-report and subsequent physician review of medical records. This is resource-intensive. Herein, we assess whether Medicare data can reliably assess stroke events in the WHI. Subjects were WHI participants with fee-for-service Medicare. Four stroke definitions were created for Medicare data using discharge diagnoses in hospitalization claims: definition 1, stroke codes in any position; definition 2, primary position stroke codes; and definitions 3 and 4, hemorrhagic and ischemic stroke codes, respectively. WHI data were randomly split into training (50%) and test sets. A concordance matrix was used to examine the agreement between WHI and Medicare stroke diagnosis. A WHI stroke and a Medicare stroke were considered a match if they occurred within ±7 days of each other. Refined analyses excluded Medicare events when medical records were unavailable for comparison. Training data consisted of 24 428 randomly selected participants. There were 577 WHI strokes and 557 Medicare strokes using definition 1. Of these, 478 were a match. With regard to algorithm performance, specificity was 99.7%, negative predictive value was 99.7%, sensitivity was 82.8%, positive predictive value was 85.8%, and κ=0.84. Performance was similar for test data. Whereas specificity and negative predictive value exceeded 99%, sensitivity ranged from 75% to 88% and positive predictive value ranged from 80% to 90% across stroke definitions. Medicare data seem useful for population-based stroke research; however, performance characteristics depend on the definition selected.

  19. Hearing Impairment Affects Dementia Incidence. An Analysis Based on Longitudinal Health Claims Data in Germany

    Science.gov (United States)

    Teipel, Stefan; Óvári, Attila; Kilimann, Ingo; Witt, Gabriele; Doblhammer, Gabriele

    2016-01-01

    Recent research has revealed an association between hearing impairment and dementia. The objective of this study is to determine the effect of hearing impairment on dementia incidence in a longitudinal study, and whether ear, nose, and throat (ENT) specialist care, care level, institutionalization, or depression mediates or moderates this pathway. The present study used a longitudinal sample of 154,783 persons aged 65 and older from claims data of the largest German health insurer; containing 14,602 incident dementia diagnoses between 2006 and 2010. Dementia and hearing impairment diagnoses were defined according to International Classification of Diseases, Tenth Revision, codes. We used a Kaplan Meier estimator and performed Cox proportional hazard models to explore the effect of hearing impairment on dementia incidence, controlling for ENT specialist care, care level, institutionalization, and depression. Gender, age, and comorbidities were controlled for as potential confounders. Patients with bilateral (HR = 1.43, pimpairment had higher risks of dementia incidence than patients without hearing impairment. We found no significant effect for unilateral hearing impairment and other diseases of the ear. The effect of hearing impairment was only partly mediated through ENT specialist utilization. Significant interaction between hearing impairment and specialist care, care level, and institutionalization, respectively, indicated moderating effects. We discuss possible explanations for these effects. This study underlines the importance of the association between hearing impairment and dementia. Preserving hearing ability may maintain social participation and may reduce the burden associated with dementia. The particular impact of hearing aid use should be the subject of further investigations, as it offers potential intervention on the pathway to dementia. PMID:27391486

  20. Global income related health inequalities

    Directory of Open Access Journals (Sweden)

    Jalil Safaei

    2007-01-01

    Full Text Available Income related health inequalities have been estimated for various groups of individuals at local, state, or national levels. Almost all of theses estimates are based on individual data from sample surveys. Lack of consistent individual data worldwide has prevented estimates of international income related health inequalities. This paper uses the (population weighted aggregate data available from many countries around the world to estimate worldwide income related health inequalities. Since the intra-country inequalities are subdued by the aggregate nature of the data, the estimates would be those of the inter-country or international health inequalities. As well, the study estimates the contribution of major socioeconomic variables to the overall health inequalities. The findings of the study strongly support the existence of worldwide income related health inequalities that favor the higher income countries. Decompositions of health inequalities identify inequalities in both the level and distribution of income as the main source of health inequality along with inequalities in education and degree of urbanization as other contributing determinants. Since income related health inequalities are preventable, policies to reduce the income gaps between the poor and rich nations could greatly improve the health of hundreds of millions of people and promote global justice. Keywords: global, income, health inequality, socioeconomic determinants of health

  1. 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.

  2. Treatment Patterns, Complications, and Health Care Utilization Among Endometriosis Patients Undergoing a Laparoscopy or a Hysterectomy: A Retrospective Claims Analysis.

    Science.gov (United States)

    Surrey, Eric S; Soliman, Ahmed M; Yang, Hongbo; Du, Ella Xiaoyan; Su, Bowdoin

    2017-11-01

    Hysterectomy and laparoscopy are common surgical procedures used for the treatment of endometriosis. This study compares outcomes for women who received either procedure within the first year post initial surgery. The study used data from the Truven Health MarketScan claims databases from 2004 to 2013 to identify women aged 18-49 years who received an endometriosis-related laparoscopy or hysterectomy. Patients were excluded if they did not have continuous insurance coverage from 1 year before through 1 year after their endometriosis-related procedure, if they were diagnosed with uterine fibroids prior to or on the date of surgery (i.e., index date), or if they had a hysterectomy prior to the index date. The descriptive analyses examined differences between patients with an endometriosis-related laparoscopy or hysterectomy in regard to medications prescribed, complications, and hospitalizations during the immediate year post procedure. The final sample consisted of 24,915 women who underwent a hysterectomy and 37,308 who underwent a laparoscopy. Results revealed significant differences between the cohorts, with women who received a laparoscopy more likely to be prescribed a GnRH agonist, progestin, danazol, or an opioid analgesic in the immediate year post procedure compared to women who underwent a hysterectomy. In contrast, women who underwent a hysterectomy generally had higher complication rates. Index hospitalization rates and length of stay (LOS) were higher for women who had a hysterectomy, while post-index hospitalization rates and LOS were higher for women who had a laparoscopy. For both cohorts, post-procedure complications were associated with significantly higher hospitalization rates and longer LOS. This study indicated significantly different 1-year post-surgical outcomes for patients who underwent an endometriosis-related hysterectomy relative to a laparoscopy. Furthermore, the endometriosis patients in this analysis had a considerable risk of

  3. 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...

  4. Doenças do trabalho e benefícios previdenciários relacionados à saúde, Bahia, 2000 Enfermedades del trabajo y beneficios de la previsión relacionados a la salud, Bahia (Brasil, 2000 Work-related diseases and health-related compensation claims, Northeastern Brazil, 2000

    Directory of Open Access Journals (Sweden)

    Norma Suely Souto Souza

    2008-08-01

    por agravamientos a la salud por el Instituto Nacional do Seguro Social, en el estado de Bahia (Nordeste de Brasil, en 2000. Fueron considerados como casos todos los diagnósticos clínicos constantes de CID-10, con excepción de las causas externas y factores que influencian el contacto con los servicios de salud. La vinculación del diagnóstico con la ocupación se baso en el código CID-10 y si la especie de beneficio era "accidentaria". RESULTADOS: De los beneficios, 3,1% fueron concedidos para enfermedades de trabajo: 70% eran enfermedades del sistema osteomuscular y del tejido conjuntivo y 14,5% del sistema nervioso. En general, beneficios concedidos en una frecuencia mas grande que el doble de lo esperado fueron: para tenossinovites en la industria de transformación (Razón de Proporción-RP=2,70, síndrome del túnel del carpo en la intermediación financiera (RP=2,43 y trastornos del disco lumbar en el ramo del transporte, correo y telecomunicaciones (RP=2,17. Sin embargo, no fue establecido nexo causal para estas enfermedades, en estos ramos de actividad, en porcentual significativo de beneficios. CONCLUSÕES: Los resultados sugieren la existencia de posibles factores de riesgo ocupacionales para enfermedades en estos ramos de actividad, como también el sub-registro de la vinculación de las patologías con el trabajo, camuflando la responsabilidad de las empresas y la perspectiva de premención por la reorganización del trabajo.OBJECTIVE: To estimate the contribution of work-related diseases to sick leaves due to general and occupational health problems. METHODS: 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

  5. Violence related to health work

    Directory of Open Access Journals (Sweden)

    Juliana da Silva Oliveira

    2014-10-01

    Full Text Available This study aimed to present a critical and reflective literature review on the violence related to health work. The survey was conducted through an integrated search in the Virtual Health Library in the months of May and June 2011. We selected 24 articles. The reading of the material led us to the following division results: studies characterization and bioethical reflection on violence related to health work. The work-related violence has consequences not only direct on professionals’ health, but also for the citizen and society as a whole. Make it visible is the first action needed for prevention / control and to promote healthier workplaces.

  6. VIOLENCE RELATED TO HEALTH WORK

    Directory of Open Access Journals (Sweden)

    Juliana da Silva Oliveira

    2014-03-01

    Full Text Available This study aimed to present a critical and reflective literature review on the violence related to health work. The survey was conducted through an integrated search in the Virtual Health Library in the months of May and June 2011. We selected 24 articles. The reading of the material led us to the following division results: studies characterization and bioethical reflection on violence related to health work. The work-related violence has consequences not only direct on professionals’ health, but also for the citizen and society as a whole. Make it visible is the first action needed for prevention / control and to promote healthier workplaces.

  7. 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.

  8. 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.

  9. 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.

  10. HEALTH INFO SANTÉ – REMINDER ANNUAL DEDUCTIBLE AND REIMBURSEMENT CLAIMS HINTS FOR USE

    CERN Multimedia

    CHIS Board

    2000-01-01

    Information from the CHIS Board and the Human Resources Division:Annual deductible and reimbursement claims: hints for useOne 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 neither 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 54, 000 in 1999 - is part of the cost of our insurance.Help keep administrative costs down: do not submit reimbursement cl...

  11. Occupational accident and disease claims, work-related stress and job satisfaction of physiotherapists.

    Science.gov (United States)

    Brattig, Birte; Schablon, Anja; Nienhaus, Albert; Peters, Claudia

    2014-01-01

    Physiotherapists are exposed to diverse occupational demands. Until now, little has been known about the interaction between occupational stress and the job satisfaction of physiotherapists. This paper aims to examine their work-related stress and job satisfaction. It will analyse accidents at work and occupational diseases of physiotherapists along with work-related physical and psychosocial stress and job satisfaction. We analysed routine data of the German Institute for Statutory Accident Insurance and Prevention in the Health and Welfare Services (BGW) on accidents at work and occurring en route to/from work as well as occupational diseases of physiotherapists. Work-related stress and job satisfaction were examined in a cross-sectional survey using a standard questionnaire to be completed by subjects themselves. Between 2007 and 2011, 1,229 cases of occupational disease were reported to the BGW. The majority of reports involved skin diseases (73%). Stumbles and falls were the most frequent causes of accidents at work (42.9%). Eighty-five physiotherapists all over Germany took part in the survey. They experience high quantitative demands at work. The main physical demands consist of a torso posture between 45° and 90° and high hand activity. Of the 85 subjects, 51% suffer from complaints of the musculoskeletal system in the neck and thoracic spine area and 24% have skin diseases. Most physiotherapists (88%) are satisfied with their work overall. This is aided by a high degree of influence on their work and breaks, by practical application of skills and expert knowledge, high regard for their profession, varied work and a good atmosphere at work. Reservations tend to be about statutory regulations and the social benefits provided by the German healthcare system. Overall, despite high demands and stress relating to the adequacy of resources, the majority of physiotherapists surveyed seem to be satisfied with their job. The main focus of action to promote the

  12. 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).

  13. 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...

  14. 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.

  15. Fabenol® Max, a standardised aqueous extract from Phaseolus vulgaris L., and ‘reduces the absorption of carbohydrates’: evaluation of a health claim pursuant toArticle 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 Fabenol® Max and ‘reduces the absorption of carbohydrates’. The Panel considers that Fabenol® Max, which is an aqueous extract from Phaseolus vulgaris L. standardised by its content of α-amylase inhibitor, is sufficiently characterised. According...

  16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225) and improving immune defence against pathogenic gastro-intestinal microorganisms (ID 896), and protection, of the skin from UV-induced damage (ID 900) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    claims in relation to Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225) and improving immune defence against pathogenic gastro-intestinal microorganisms, and protection of the skin from UV-induced damage. The scientific substantiation is based on the information provided by the Member States...

  17. 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.

  18. 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.

  19. 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.

  20. 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...

  1. 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.

  2. Major surgery in south India: a retrospective audit of hospital claim data from a large community health insurance programme.

    Science.gov (United States)

    Shaikh, Maaz; Woodward, Mark; Rahimi, Kazem; Patel, Anushka; Rath, Santosh; MacMahon, Stephen; Jha, Vivekanand

    2015-04-27

    Information about use of major surgery in India is scarce. This study aims to bridge this gap by auditing hospital claims from the Rajiv Aarogyasri Community Health Insurance Scheme (RACHIS) that provides access to free tertiary care for major surgery through state-funded insurance to 68 million beneficiaries with limited household incomes-81% of population in states of Telangana and Andhra Pradesh (combined Human Development Index 0·485). Beneficiary households receive an annual coverage of INR 200 000 (US$3333) for admissions to any empanelled public or private hospital. Publicly available deidentified hospital claim data for all surgical procedures conducted between mid-2008 and mid-2012 were compiled across all 23 districts in Telangana and Andhra Pradesh. 677 332 surgical admissions (80% at private hospitals) were recorded at a mean annual rate of 259 per 100 000 beneficiaries (95% CI 235-283), excluding cataract and caesarean sections as these were not covered under the insurance programme. Men accounted for 56% of admissions. Injury was the most common cause for surgical admission (185 733; 27%) with surgical correction of long bone fractures being the most common procedure (144 997; 20%) identified in the audit. Diseases of digestive (110 922; 16%), genitourinary (82 505; 12%), and musculoskeletal system (70 053; 10%) were other leading causes for surgical admissions. Most hospital bed-days were used for injuries (584 days per 100 000 person years; 31%), digestive diseases (314 days; 17%), and musculoskeletal system (207 days; 11%), costing 19% (INR 4·4 billion), 13% (3·03 billion), and 11% (2·5 billion) of claims, respectively. Cardiovascular surgeries (53 023; 8%) alone accounted for 21% (INR 4·9 billion) of cost. Annual per capita cost of surgical claims was US$1·49 (95% CI 1·32-1·65). Our findings are limited to a population socioeconomically representative of India and other countries with low-income and middle

  3. Health care resource use and costs associated with possible side effects of high oral corticosteroid use in asthma: a claims-based analysis.

    Science.gov (United States)

    Luskin, Allan T; Antonova, Evgeniya N; Broder, Michael S; Chang, Eunice Y; Omachi, Theodore A; Ledford, Dennis K

    2016-01-01

    The objective of this study was to estimate the prevalence of possible oral corticosteroid (OCS)-related side effects and health care resource use and costs in patients with asthma. This was a cross-sectional, matched-cohort, retrospective study using a commercial claims database. Adults with asthma diagnosis codes and evidence of asthma medication use were studied. Patients with high OCS use (≥30 days of OCS annually) were divided into those who did versus those who did not experience OCS-related possible side effects. Their health care resource use and costs were compared using linear regression or negative binomial regression models, adjusting for age, sex, geographic region, Charlson Comorbidity Index score, and chronic obstructive pulmonary disease status. After adjustment, high OCS users with possible side effects were more likely to have office visits (23.0 vs 19.6; P possible side effects. Emergency department visits were similar between the groups. High OCS users with possible side effects had higher adjusted total annual mean health care costs ($25,168) than those without such side effects ($21,882; P =0.009). Among high OCS users, patients with possible OCS-related side effects are more likely to use health care services than those without such side effects. Although OCS may help control asthma and manage exacerbations, OCS side effects may result in additional health care resource use and costs, highlighting the need for OCS-sparing asthma therapies.

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

    Science.gov (United States)

    Ma, Alison; Parkin, Lianne

    2015-09-04

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

  5. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to melatonin and reduction of sleep onset latency (ID 1698, 1780, 4080) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    in healthy subjects combined with subjects with insomnia. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of melatonin and reduction of sleep onset latency. The Panel considers that in order to obtain the claimed effect...

  6. Secondary Use of Claims Data from the Austrian Health Insurance System with i2b2: A Pilot Study.

    Science.gov (United States)

    Endel, Florian; Duftschmid, Georg

    2016-01-01

    In conformity with increasing international efforts to reuse routine health data for scientific purposes, the Main Association of Austrian Social Security Organisations provides pseudonymized claims data of the Austrian health care system for clinical research. We aimed to examine, whether an integration of the corresponding database into i2b2 would be possible and provide benefits. We applied docker-based software containers and data transformations to set up the system. To assess the benefits of i2b2 we plan to reenact the task of cohort formation of an earlier research project. The claims database was successfully integrated into i2b2. The docker-based installation approach will be published as git repository. The assessment of i2b2's benefits is currently work in progress and will be presented at the conference. Docker enables a flexible, reproducible, and resource-efficient installation of i2b2 within the restricted environment implied by our highly secured target system. First preliminary tests indicated several potential benefits of i2b2 compared to the methods applied during the earlier research project.

  7. 76 FR 46684 - Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical...

    Science.gov (United States)

    2011-08-03

    ..., 433, 447, and 457 [CMS-2292-P] RIN 0938-AQ32 Medicaid and Children's Health Insurance Programs... Children's Health Insurance Program (CHIP) disallowance process to allow States the option to retain... [[Page 46685

  8. 77 FR 31499 - Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical...

    Science.gov (United States)

    2012-05-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 430, 433, 447, and 457 [CMS-2292-F] RIN 0938-AQ32 Medicaid and Children's Health Insurance Programs... Children's Health Insurance Program (CHIP) disallowance process to allow States the option to retain...

  9. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to soy isoflavones and maintenance of bone mineral density (ID 1655) and reduction of vasomotor symptoms associated with menopause (ID 1654, 1704, 2140, 3093, 3154, 3590

    DEFF Research Database (Denmark)

    Tetens, Inge

    and maintenance of bone mineral density and reduction of vasomotor symptoms associated with menopause. The food constituent that is the subject of the claim, soy isoflavones, is sufficiently characterised. The claimed effects, maintenance of bone mineral density and reduction of vasomotor symptoms associated...... with menopause, which are eligible for further assessment, are beneficial physiological effects. The proposed target populations are peri- and/or post-menopausal women. On the basis of the data presented, the Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship...... between the consumption of soy isoflavones and maintenance of bone mineral density, and between the consumption of soy isoflavones and reduction of vasomotor symptoms associated with menopause....

  10. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens (ID 934, further

    DEFF Research Database (Denmark)

    Tetens, Inge

    of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens. The food constituent that is the subject of the claim, a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C, is sufficiently...... presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens....

  11. Does litigation increase or decrease health care quality?: a national study of negligence claims against nursing homes.

    Science.gov (United States)

    Stevenson, David G; Spittal, Matthew J; Studdert, David M

    2013-05-01

    The tort system is supposed to help improve the quality and safety of health care, but whether it actually does so is controversial. Most previous studies modeling the effect of negligence litigation on quality of care are ecologic. To assess whether the experience of being sued and incurring litigation costs affects the quality of care subsequently delivered in nursing homes. We linked information on 6471 negligence claims brought against 1514 nursing homes between 1998 and 2010 to indicators of nursing home quality drawn from 2 US national datasets (Online Survey, Certification, and Reporting system; Minimum Data Set Quality Measure/Indicator Reports). At the facility level, we tested for associations between 9 quality measures and 3 variables indicating the nursing homes' litigation experience in the preceding 12-18 months (total indemnity payments; total indemnity payments plus administrative costs; ≥ 1 paid claims vs. none). The analyses adjusted for quality at baseline, case-mix, ownership, occupancy, year, and facility and state random effects. Nearly all combinations of the 3 litigation exposure measures and 9 quality measures--27 models in all--showed an inverse relationship between litigation costs and quality. However, only a few of these associations were statistically significant, and the effect sizes were very small. For example, a doubling of indemnity payments was associated with a 1.1% increase in the number of deficiencies and a 2.2% increase in pressure ulcer rates. Tort litigation does not increase the quality performance of nursing homes, and may decrease it slightly.

  12. 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.

  13. Claim Your Space: Leadership Development as a Research Capacity Building Goal in Global Health

    Science.gov (United States)

    Airhihenbuwa, Collins O.; Ogedegbe, Gbenga; Iwelunmor, Juliet; Jean-Louis, Girardin; Williams, Natasha; Zizi, Freddy; Okuyemi, Kolawole

    2016-01-01

    As the burden of noncommunicable diseases (NCDs) rises in settings with an equally high burden of infectious diseases in the Global South, a new sense of urgency has developed around research capacity building to promote more effective and sustainable public health and health care systems. In 2010, NCDs accounted for more than 2.06 million deaths…

  14. Adding value through health claims: an empirical analysis of the Italian yogurt market

    NARCIS (Netherlands)

    Bimbo, Francesco

    2017-01-01

    In recent years policymakers have aimed to increase the general awareness regarding the link between diet and health, providing food companies with an opportunity to add health-enhancing features in order to differentiate their products. The European market of these products, referred to here as

  15. Seasonality in acute liver injury? Findings in two health care claims databases

    Directory of Open Access Journals (Sweden)

    Weinstein RB

    2016-03-01

    Full Text Available Rachel B Weinstein, Martijn J Schuemie, Patrick B Ryan, Paul E Stang Epidemiology, Janssen Research and Development, LLC, Titusville, NJ, USA Background: Presumed seasonal use of acetaminophen-containing products for relief of cold/influenza (“flu” symptoms suggests that there might also be a corresponding seasonal pattern for acute liver injury (ALI, a known clinical consequence of acetaminophen overdose. Objective: The objective of this study was to determine whether there were any temporal patterns in hospitalizations for ALI that would correspond to assumed acetaminophen use in cold/flu season. Methods: In the period 2002–2010, monthly hospitalization rates for ALI using a variety of case definitions were calculated. Data sources included Truven MarketScan® Commercial Claims and Encounters (CCAE and Medicare Supplemental and Coordination of Benefits (MDCR databases. We performed a statistical test for seasonality of diagnoses using the periodic generalized linear model. To validate that the test can distinguish seasonal from nonseasonal patterns, we included two positive controls (ie, diagnoses of the common cold [acute nasopharyngitis] and influenza, believed to change with seasons, and two negative controls (female breast cancer and diabetes, believed to be insensitive to season. Results: A seasonal pattern was observed in monthly rates for common cold and influenza diagnoses, but this pattern was not observed for monthly rates of ALI, with or without comorbidities (cirrhosis or hepatitis, breast cancer, or diabetes. The statistical test for seasonality was significant for positive controls (P<0.001 for each diagnosis in both databases and nonsignificant for ALI and negative controls. Conclusion: No seasonal pattern was observed in the diagnosis of ALI. The positive and negative controls showed the expected patterns, strengthening the validity of the statistical and visual tests used for detecting seasonality. Keywords: acute liver

  16. The New Politics of US Health Care Prices: Institutional Reconfiguration and the Emergence of All-Payer Claims Databases.

    Science.gov (United States)

    Rocco, Philip; Kelly, Andrew S; Béland, Daniel; Kinane, Michael

    2017-02-01

    Prices are a significant driver of health care cost in the United States. Existing research on the politics of health system reform has emphasized the limited nature of policy entrepreneurs' efforts at solving the problem of rising prices through direct regulation at the state level. Yet this literature fails to account for how change agents in the states gradually reconfigured the politics of prices, forging new, transparency-based policy instruments called all-payer claims databases (APCDs), which are designed to empower consumers, purchasers, and states to make informed market and policy choices. Drawing on pragmatist institutional theory, this article shows how APCDs emerged as the dominant model for reforming health care prices. While APCD advocates faced significant institutional barriers to policy change, we show how they reconfigured existing ideas, tactical repertoires, and legal-technical infrastructures to develop a politically and technologically robust reform. Our analysis has important implications for theories of how change agents overcome structural barriers to health reform. Copyright © 2017 by Duke University Press.

  17. 75 FR 76525 - Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease

    Science.gov (United States)

    2010-12-08

    ... organizations, industry, consumer groups, health care professionals, academia, and research scientists. The... Agency for Healthcare, Research and Quality (AHRQ) to identify intervention studies that had been... increase lipid solubility of phytosterols and facilitate incorporation of phytosterols into foods. However...

  18. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations (ID 1648, 1700) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    effect refers to maintenance of normal blood LDL-cholesterol concentrations. The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect. In weighing the evidence, the Panel took into account that two randomised controlled trials provided from......-cholesterol concentrations is well established and that the mechanism by which monacolin K can contribute to the claimed effect is well known. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of monacolin K from red yeast rice...

  19. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to dried plums of „prune‟ cultivars (Prunus domestica L.) and maintenance of normal bowel function (ID 1164, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    . The proposed target population is the general population. In weighing the evidence, the Panel took into account that two human intervention studies showed an effect of dried plums on bowel function, that one study with considerable limitations showed an effect of dried plums on stool consistency......, but not on other measures of bowel function, that another study with considerable limitations did not show an effect of dried plums on bowel function when compared to dried apple, and that there is good evidence for plausible mechanisms by which some components of prunes may contribute to the claimed effect...

  20. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to oat and barley grain fibre and increase in faecal bulk (ID 819, 822) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    the evidence, the Panel took into account that the role of cereal grain fibre in increasing faecal bulk in humans is well established, that the mechanisms by which cereal grain fibre exerts the claimed effect are known, that oat fibre has a significant bulking effect in humans, and that a similar effect can...... be expected from barley grain fibre taking into account the similar composition of oat and barley fibre. The Panel concludes that a cause and effect relationship has been established between the consumption of oat and barley grain fibre and an increase in faecal bulk. The Panel considers that in order...

  1. The doctor in claims for work injuries and ill health--legal pitfalls.

    Science.gov (United States)

    Lee, See-Muah; Sng, Judy; Koh, David

    2009-08-01

    Occupational health work is currently undertaken by the specialist and the non-specialist physician alike. The work scope can vary from medical assessments of individual workers to health risk assessment at the workplace. The scope of the latter will include evaluation of exposures, hazards, risks and its management to control these risks. Much of the case law governing legal disputes over industrial safety and health have involved the employers. Over the years, the actions brought forth by workers have resulted in a formidable volume of case law based on statutes and on the common law of negligence in tort. Disputes over the assessment of workers' health or workplace health risks to the extent that it is a failure to discharge a reasonable standard of care, may result in the doctor being a defendant. Measures to prevent these legal pitfalls include communication with employers about the causative link of the illness suffered to workplace factors and the clarity of contractual obligations undertaken with regard to workplace health risk assessment.

  2. 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.

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

    Directory of Open Access Journals (Sweden)

    Jung Hoon Woo

    Full Text Available 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 < 0.001 for each. Moreover, frequent ED 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.

  4. Implications for alcohol minimum unit pricing advocacy: what can we learn for public health from UK newsprint coverage of key claim-makers in the policy debate?

    Science.gov (United States)

    Hilton, Shona; Wood, Karen; Patterson, Chris; Katikireddi, Srinivasa Vittal

    2014-02-01

    On May 24th 2012, Scotland passed the Alcohol (Minimum Pricing) Bill. Minimum unit pricing (MUP) is an intervention that raises the price of the cheapest alcohol to reduce alcohol consumption and related harms. There is a growing literature on industry's influence in policymaking and media representations of policies, but relatively little about frames used by key claim-makers in the public MUP policy debate. This study elucidates the dynamic interplay between key claim-makers to identify lessons for policy advocacy in the media in the UK and internationally. Content analysis was conducted on 262 articles from seven UK and three Scottish national newspapers between 1st May 2011 and 31st May 2012, retrieved from electronic databases. Advocates' and critics' constructions of the alcohol problem and MUP were examined. Advocates depicted the problem as primarily driven by cheap alcohol and marketing, while critics' constructions focused on youth binge drinkers and dependent drinkers. Advocates justified support by citing the intervention's targeted design, but critics denounced the policy as illegal, likely to encourage illicit trade, unsupported by evidence and likely to be ineffective, while harming the responsible majority, low-income consumers and businesses. Critics' arguments were consistent over time, and single statements often encompassed multiple rationales. This study presents advocates with several important lessons for promoting policies in the media. Firstly, it may be useful to shift focus away from young binge drinkers and heavy drinkers, towards population-level over-consumption. Secondly, advocates might focus on presenting the policy as part of a wider package of alcohol policies. Thirdly, emphasis on the success of recent public health policies could help portray the UK and Scotland as world leaders in tackling culturally embedded health and social problems through policy; highlighting past successes when presenting future policies may be a valuable

  5. 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

  6. Membership theory, rationalism, and the claim to adequacy in health services.

    Science.gov (United States)

    Falck, H S

    1997-01-01

    The immediate, practical purpose of this paper is to discuss and elaborate upon the concept of adequacy, especially when applicable to an understanding of the social work role in health policy making. The relevant topics under the general category of adequacy are (1) the perception and definition of the citizen/client; (2) the concept of rationality in health planning broken down into conditionality and prioritization, and (3) the concept of adequacy itself. Each will be addressed from the standpoint of recent experience and what may be done in the future to clarify and rationalize each. Clarity about clients, about rational approaches to policy making and planning, leading to a clear idea about adequacy in health care are presented as the indispensable elements in social work. Conditionality and prioritization are significant because no society will bring within equal reach of all members the benefits of health care, which usually means that health care is not rendered arbitrarily but as a result, among other things, of rational planning.

  7. Do health claims add value? the role of functionality, effectiveness and brand

    NARCIS (Netherlands)

    Bimbo, Francesco; Bonanno, Alessandro; Viscecchia, Rosaria

    2016-01-01

    European functional food manufacturers experience high costs of production, marketing and compliance with Regulation EC No. 1924/2006, requiring high premiums to recover these costs. We review the literature on consumers' acceptance of health-enhancing food products and identify three factors

  8. 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...

  9. Depression management within GP-centered health care - A case-control study based on claims data.

    Science.gov (United States)

    Freytag, Antje; Krause, Markus; Lehmann, Thomas; Schulz, Sven; Wolf, Florian; Biermann, Janine; Wasem, Jürgen; Gensichen, Jochen

    For most patients with depression, GPs are the first and long-term medical providers. GP-centered health care (GPc-HC) programs target patients with chronic diseases. What are the effects of GPc-HC on primary care depression management? An observational retrospective case-control study was conducted using health insurance claims data of patients with depressive disorder from July 2011 to December 2012. From 40,298 patients insured with the largest health plan in Central Germany participating in the GPc-HC program (intervention group, IG), we observed 4645 patients with depression over 18months: 72.2% women; 66.6years (mean); multiple conditions (morbidity-weight 2.50 (mean), 86%>1.0). We compared them with 4013 patients who did not participate (control group). In participants we found lower number of incomplete/non-specified depression diagnoses (4.46vs.4.82;MD-0.36; pcare" (38.2%vs.30.2%;PP+8.0;pDepressive patients participating in a GPc-HC program may be more often diagnosed by a GP, receive symptom-monitoring and appropriate depression treatment. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. 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.

  11. Does litigation increase or decrease health care quality? A national study of negligence claims against nursing homes

    Science.gov (United States)

    Stevenson, David G.; Spittal, Matthew J.; Studdert, David M.

    2016-01-01

    Background The tort system is supposed to help improve the quality and safety of health care, but whether it actually does so is controversial. Most previous studies modeling the effect of negligence litigation on quality of care are ecologic. Objective To assess whether the experience of being sued and incurring litigation costs affects the quality of care subsequently delivered in nursing homes. Research Design, Subjects, Measures We linked information on 6,471 negligence claims brought against 1,514 nursing homes between 1998 and 2010 to indicators of nursing home quality drawn from two U.S. national datasets (Online Survey, Certification, and Reporting system; Minimum Data Set Quality Measure/Indicator Reports). At the facility level, we tested for associations between 9 quality measures and 3 variables indicating the nursing homes’ litigation experience in the preceding 12–18 months (total indemnity payments; total indemnity payments plus administrative costs; ≥1 paid claims vs. none). The analyses adjusted for quality at baseline, case-mix, ownership, occupancy, year, and facility and state random effects. Results Nearly all combinations of the 3 litigation exposure measures and 9 quality measures—27 models in all—showed an inverse relationship between litigation costs and quality. However only a few of these associations were statistically significant, and the effect sizes were very small. For example, a doubling of indemnity payments was associated with a 1.1% increase in the number of deficiencies and a 2.2% increase in pressure ulcer rates. Conclusions Tort litigation does not increase the quality performance of nursing homes, and may decrease it slightly. PMID:23552438

  12. 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.

  13. Alternatives to litigation for health care conflicts and claims: alternative dispute resolution in medicine.

    Science.gov (United States)

    Dauer, Edward A

    2002-12-01

    Health care has undergone radical changes, and it may be predicted that further changes are in the offing as the burdens and the benefits of the newer configurations become known. Change in any system stresses it, creating opportunities for conflict as people and organizations adjust to new realities and encounter changed expectations. The opportunities for conflict in health care (and legal conflict with it), therefore, have been and will continue to be a measurable part of health care's daily life. Many of these conflicts can be managed through one or another of the several forms of ADR. Some ADR procedures are most productive when used as alternatives to impending litigation. Others may be employed when litigation is not likely but when the persistence of conflict, such as that within a newly structured provider organization, would otherwise take its toll on the productivity of the organization and those who work within it. The challenge in using ADR for any of these problems is similar to what physicians understand as differential diagnosis. A good therapy applied to the wrong case yields a bad result. The world of ADR has matured to the point at which the salient features of both cases and procedures are well-enough understood to allow for low-risk and high-benefit applications. This is particularly true for disputes involving allegations of medical error, where the indicators of efficacy are very positive and the risks to safety are comfortably low. Mediation in particular, but mediation of the interest-based style rather than the settlement conference style, deserves fuller consideration and broader use.

  14. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to β-hydroxy β-methylbutyrate monohydrate (HMB) alone or in combination with α-ketoisocaproic acid (KIC) and reduction of muscle tissue damage during exercise (ID 1577, , 1584), increase in lean body mass (ID 1579, 1582, 1583), increase in muscle strength (ID 1578, 1583, 1587), increase in endurance performance (ID 1580, 1581), skeletal muscle tissue repair (ID 1586) and faster recovery from muscle fatigue after exercise (ID 1576, 1585) pursuant to Article 13

    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...... 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 constituent...

  15. 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...

  16. Polydextrose and 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

    2016-01-01

    Following an application from Tate & Lyle PLC 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...

  17. Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2017-01-01

    Following an application from Loc Troi group, submitted for 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...

  18. Anxiofit-1 and reduction of subthreshold and mild anxiety: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    Following an application from Anxiofit Ltd. and ExtractumPharma Co Ltd., submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

  19. Iron and contribution to the normal function of the immune system: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    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...

  20. Vitamin C and protection of DNA, proteins and lipids from oxidative damage: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2017-01-01

    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...

  1. Vitamin C and contribution to the normal function of the immune system: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2015-01-01

    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...

  2. Curcumin and normal functioning of joints: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2017-01-01

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

  3. Vitamin E and protection of DNA, proteins and lipids from oxidative damage: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    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...

  4. DHA and improvement of memory function: 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

    Following an application from DSM Nutritional Products, 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...

  5. Calcium and contribution to the normal development of bones: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Sjödin, Anders Mikael

    2016-01-01

    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...

  6. 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

  7. Health system responsiveness and chronic disease care - What is the role of disease management programs? An analysis based on cross-sectional survey and administrative claims data.

    Science.gov (United States)

    Röttger, Julia; Blümel, Miriam; Linder, Roland; Busse, Reinhard

    2017-07-01

    Health system responsiveness is an important aspect of health systems performance. The concept of responsiveness relates to the interpersonal and contextual aspects of health care. While disease management programs (DMPs) aim to improve the quality of health care (e.g. by improving the coordination of care), it has not been analyzed yet whether these programs improve the perceived health system responsiveness. Our study aims to close this gap by analyzing the differences in the perceived health system responsiveness between DMP-participants and non-participants. We used linked survey- and administrative claims data from 7037 patients with coronary heart disease in Germany. Of those, 5082 were enrolled and 1955 were not enrolled in the DMP. Responsiveness was assessed with an adapted version of the WHO responsiveness questionnaire in a postal survey in 2013. The survey covered 9 dimensions of responsiveness and included 17 items for each, GP and specialist care. Each item had five answer categories (very good - very bad). We handled missing values in the covariates by multiple imputation and applied propensity score matching (PSM) to control for differences between the two groups (DMP/non-DMP). We used Wilcoxon-signed-rank and McNemar test to analyze differences regarding the reported responsiveness. The PSM led to a matched and well balanced sample of 1921 pairs. Overall, DMP-participants rated the responsiveness of care more positive. The main difference was found for the coordination of care at the GP, with 62.0% of 1703 non-participants reporting a "good" or "very good" experience, compared to 69.1% of 1703 participants (p < 0.001). The results of our study indicate an overall high responsiveness for CHD-care, as well for DMP-participants as for non-participants. Yet, the results also clearly indicate that there is still a need to improve the coordination of care. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Health claims database study of cyclosporine ophthalmic emulsion treatment patterns in dry eye patients

    Science.gov (United States)

    Stonecipher, Karl G; Chia, Jenny; Onyenwenyi, Ahunna; Villanueva, Linda; Hollander, David A

    2013-01-01

    Background Dry eye is a multifactorial, symptomatic disease associated with ocular surface inflammation and tear film hyperosmolarity. This study was designed to assess patterns of topical cyclosporine ophthalmic emulsion 0.05% (Restasis®) use in dry eye patients and determine if there were any differences in use based on whether dry eye is physician-coded as a primary or nonprimary diagnosis. Methods Records for adult patients with a diagnosis of dry eye at an outpatient visit from January 1, 2008 to December 31, 2009 were selected from Truven Health MarketScan® Research Databases. The primary endpoint was percentage of patients with at least one primary versus no primary dry eye diagnosis who filled a topical cyclosporine prescription. Data analyzed included utilization of topical corticosteroids, oral tetracyclines, and punctal plugs. Results The analysis included 576,416 patients, accounting for 875,692 dry eye outpatient visits: 74.7% were female, 64.2% were ages 40–69 years, and 84.4% had at least one primary dry eye diagnosis. During 2008–2009, 15.9% of dry eye patients with a primary diagnosis versus 6.5% with no primary diagnosis filled at least one cyclosporine prescription. For patients who filled at least one prescription, the mean months’ supply of cyclosporine filled over 12 months was 4.44. Overall, 33.9% of dry eye patients filled a prescription for topical cyclosporine, topical corticosteroid, or oral tetracycline over 2 years. Conclusion Patients with a primary dry eye diagnosis were more likely to fill a topical cyclosporine prescription. Although inflammation is key to the pathophysiology of dry eye, most patients seeing a physician for dry eye may not receive anti-inflammatory therapies. PMID:24179335

  9. Health claims database study of cyclosporine ophthalmic emulsion treatment patterns in dry eye patients.

    Science.gov (United States)

    Stonecipher, Karl G; Chia, Jenny; Onyenwenyi, Ahunna; Villanueva, Linda; Hollander, David A

    2013-01-01

    Dry eye is a multifactorial, symptomatic disease associated with ocular surface inflammation and tear film hyperosmolarity. This study was designed to assess patterns of topical cyclosporine ophthalmic emulsion 0.05% (Restasis®) use in dry eye patients and determine if there were any differences in use based on whether dry eye is physician-coded as a primary or nonprimary diagnosis. Records for adult patients with a diagnosis of dry eye at an outpatient visit from January 1, 2008 to December 31, 2009 were selected from Truven Health MarketScan® Research Databases. The primary endpoint was percentage of patients with at least one primary versus no primary dry eye diagnosis who filled a topical cyclosporine prescription. Data analyzed included utilization of topical corticosteroids, oral tetracyclines, and punctal plugs. The analysis included 576,416 patients, accounting for 875,692 dry eye outpatient visits: 74.7% were female, 64.2% were ages 40-69 years, and 84.4% had at least one primary dry eye diagnosis. During 2008-2009, 15.9% of dry eye patients with a primary diagnosis versus 6.5% with no primary diagnosis filled at least one cyclosporine prescription. For patients who filled at least one prescription, the mean months' supply of cyclosporine filled over 12 months was 4.44. Overall, 33.9% of dry eye patients filled a prescription for topical cyclosporine, topical corticosteroid, or oral tetracycline over 2 years. Patients with a primary dry eye diagnosis were more likely to fill a topical cyclosporine prescription. Although inflammation is key to the pathophysiology of dry eye, most patients seeing a physician for dry eye may not receive anti-inflammatory therapies.

  10. Health claims database study of cyclosporine ophthalmic emulsion treatment patterns in dry eye patients

    Directory of Open Access Journals (Sweden)

    Stonecipher KG

    2013-10-01

    Full Text Available Karl G Stonecipher,1 Jenny Chia,2 Ahunna Onyenwenyi,2 Linda Villanueva,2 David A Hollander2 1TLC Laser Eye Centers, Greensboro, NC, 2Allergan, Inc., Irvine, CA, USA Background: Dry eye is a multifactorial, symptomatic disease associated with ocular surface inflammation and tear film hyperosmolarity. This study was designed to assess patterns of topical cyclosporine ophthalmic emulsion 0.05% (Restasis® use in dry eye patients and determine if there were any differences in use based on whether dry eye is physician-coded as a primary or nonprimary diagnosis. Methods: Records for adult patients with a diagnosis of dry eye at an outpatient visit from January 1, 2008 to December 31, 2009 were selected from Truven Health MarketScan® Research Databases. The primary endpoint was percentage of patients with at least one primary versus no primary dry eye diagnosis who filled a topical cyclosporine prescription. Data analyzed included utilization of topical corticosteroids, oral tetracyclines, and punctal plugs. Results: The analysis included 576,416 patients, accounting for 875,692 dry eye outpatient visits: 74.7% were female, 64.2% were ages 40-69 years, and 84.4% had at least one primary dry eye diagnosis. During 2008–2009, 15.9% of dry eye patients with a primary diagnosis versus 6.5% with no primary diagnosis filled at least one cyclosporine prescription. For patients who filled at least one prescription, the mean months’ supply of cyclosporine filled over 12 months was 4.44. Overall, 33.9% of dry eye patients filled a prescription for topical cyclosporine, topical corticosteroid, or oral tetracycline over 2 years. Conclusion: Patients with a primary dry eye diagnosis were more likely to fill a topical cyclosporine prescription. Although inflammation is key to the pathophysiology of dry eye, most patients seeing a physician for dry eye may not receive anti-inflammatory therapies. Keywords: corticosteroids, cyclosporine, dry eye syndromes

  11. The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world.

    Science.gov (United States)

    Dronkers, T M G; Krist, L; Van Overveld, F J; Rijkers, G T

    2018-05-25

    The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

  12. 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

  13. Impact of a Health Management Program on Healthcare Outcomes among Patients on Augmentation Therapy for Alpha 1-Antitrypsin Deficiency: An Insurance Claims Analysis.

    Science.gov (United States)

    Campos, Michael A; Runken, Michael C; Davis, Angela M; Johnson, Michael P; Stone, Glenda A; Buikema, Ami R

    2018-04-01

    Alpha 1-antitrypsin deficiency (AATD) is a genetic disorder which reduces serum alpha 1-antitrypsin (AAT or alpha1-proteinase inhibitor, A1PI) and increases the risk of chronic obstructive pulmonary disease (COPD). Management strategies include intravenous A1PI augmentation, and, in some cases, a health management program (Prolastin Direct ® ; PD). This study compared clinical and economic outcomes between patients with and without PD program participation. This retrospective study included commercial and Medicare Advantage health insurance plan members with ≥ 1 claim with diagnosis codes for COPD and ≥ 1 medical or pharmacy claim including A1PI (on index date). Outcomes were compared between patients receiving only Prolastin ® or Prolastin ® -C (PD cohort) and patients who received a different brand without PD (Comparator cohort). Demographic and clinical characteristics were captured during 6 months pre-index. Post-index exacerbation episodes and healthcare utilization and costs were compared between cohorts. The study sample comprised 445 patients (n = 213 in PD cohort; n = 232 in Comparator cohort), with a mean age 55.5 years, 50.8% male, and 78.9% commercially insured. The average follow-up was 822 days (2.25 years), and the average time on A1PI was 747 days (2.04 years). Few differences were observed in demographic or clinical characteristics. Adjusting for differences in patient characteristics, the rate of severe exacerbation episodes was reduced by 36.1% in the PD cohort. Adjusted total annual all-cause costs were 11.4% lower, and adjusted mean respiratory-related costs were 10.6% lower in the PD cohort than the Comparator cohort. Annual savings in all-cause total costs in the PD cohort relative to the Comparator cohort was US$25,529 per patient, largely due to significantly fewer and shorter hospitalizations. These results suggest that comprehensive health management services may improve both clinical and economic outcomes among

  14. Linking primary study data with administrative and claims data in a German cohort study on work, age, health and work participation: is there a consent bias?

    Science.gov (United States)

    Stallmann, C; Swart, E; Robra, B-P; March, S

    2017-09-01

    We analysed the degree and impact of consent bias in the prospective study 'leben in der Arbeit (lidA)' after linking primary interview data with claims data from German statutory health insurance funds as well as with administrative data provided by the German Federal Employment Agency. Prospective cohort study. Within two study waves (2011, 2014) primary data were collected based on computer-assisted personal interviews. During interview informed consent to data linkage was obtained. We used binary logistic regression analyses with participants' consent for record linkage as the dependent variable calculating odds ratios (ORs) and 95% confidence intervals (95% CIs) for independent variables. Several sociodemographic, socio-economic and work-related factors were modelled as potential determinants of consent. A total of 4244 participants took part in both waves. After excluding invalid consent, 4178 participants were included in the analysis. About 3918 (93.8%) of these participants gave their consent to link their primary data with data from at least one source. Within regression analyses only moderate bias was found due to region of residence, apprenticeship, professional affiliations, income and number of diseases. Participants from former West Germany were less likely to have their study data linked with both data sources (OR 0.63 [95% CI 0.42-0.96]) than those from the former East Germany. Participants with no information on income were more likely to refuse consent to both data sources compared to the reference group (net income: under EUR 1000; OR 0.15 [95% CI 0.08-0.30]). Respondents with two (OR 1.37 [95% CI 1.06-1.77]) or three and more diseases (OR 1.30 [95% CI 1.02-1.66]) diagnosed by a doctor agreed more frequently to linking both data sources than participants without disease. There is just a small proportion of variance in consenting explained by the models (R 2 : 0.063-0.085). Also, only small changes of factors' prevalence were observed in

  15. Is eating organic a healthy or safer option? Health claims for organic food consumption, food quality and safety – A systematic review

    Directory of Open Access Journals (Sweden)

    Sneha Ghai

    2017-12-01

    Full Text Available Universally, there has been an increased awareness about the harmful effects of chemical inputs used for production of food on soil composition, environment and human health. This has triggered the consumption level of organic food products. India has witnessed a tremendous growth in domestic as well as export market. The demand is mainly driven by consumer perceptions that organic farming is more sustainable, produces healthy food, pesticide-free and safeguards the environment & biodiversity. Organic food producers also manifests the quality and safety of food. These claims which are perceived and professed as beneficial can only be accepted if they are tested and validated. Therefore, the foremost objective of this review paper is to provide an update on set of studies related to scientific evidence for nutritional composition marking the quality of organic foods vis-à-vis conventional foods and its impact on human health. Secondly, the paper examines the comparison of the sensory quality of the organic food, and thirdly the food safety aspect of organically as compared with conventionally grown foods. Past few controlled studies have proved that there is no such evidence of differences in concentration of various nutrients amongst organic and conventional foods. Furthermore, there are certain issues related to the impact and assessment of these nutrients in organic food which requires some future directives. Owing to the heterogeneity in results observed related to nutritional quality and safety of organic foods, technological aspects together with sensory parameters are the best for future comparative studies. To safeguard the public health and to avoid the difference in sampling and sample results, testing laboratories should also be adhering to uniform standards. Organic food business in India lack standard guidelines for quality, policy framework for domestic and export market. Also, traceability is another factor which should be given

  16. Using Technology to Claim Rights to Free Maternal Health Care: Lessons about Impact from the My Health, My Voice Pilot Project in India.

    Science.gov (United States)

    Dasgupt, Jashodhara; Sandhya, Y K; Lobis, Samantha; Verma, Pravesh; Schaaf, Marta

    2015-12-10

    My Health, My Voice is a human rights-based project that pilots the use of technology to monitor and display online data regarding informal payments for maternal health care in two districts of Uttar Pradesh, India. SAHAYOG, an organization based in Uttar Pradesh, partnered with a grassroots women's forum to inform women about their entitlements, to publicize the project, and to implement a toll-free hotline where women could report health providers' demands for informal payments. Between January 2012 and May 2013, the hotline recorded 873 reports of informal payment demands. Monitoring and evaluation revealed that the project enhanced women's knowledge of their entitlements, as well as their confidence to claim their rights. Anecdotal evidence suggests that health providers' demands for informal payments were reduced in response to the project, although hospital and district officials did not regularly consult the data. The use of technology accorded greater legitimacy among governmental stakeholders. Future research should examine the sustainability of changes, as well as the mechanisms driving health sector responsiveness. Copyright © 2015 Dasgupta et al. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.

  17. 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

  18. Health care resource use and costs associated with possible side effects of high oral corticosteroid use in asthma: a claims-based analysis

    Directory of Open Access Journals (Sweden)

    Luskin AT

    2016-10-01

    Full Text Available Allan T Luskin,1 Evgeniya N Antonova,2 Michael S Broder,3 Eunice Y Chang,3 Theodore A Omachi,2 Dennis K Ledford4 1HealthyAirways, Madison, WI, 2Genentech, Inc., South San Francisco, 3Partnership for Health Analytic Research, LLC, Beverly Hills, CA, 4Division of Allergy and Immunology, Department of Medicine, James A. Haley Veterans’ Hospital, Morsani College of Medicine, University of South Florida, Tampa, FL, USA Background: The objective of this study was to estimate the prevalence of possible oral corticosteroid (OCS-related side effects and health care resource use and costs in patients with asthma.Methods: This was a cross-sectional, matched-cohort, retrospective study using a commercial claims database. Adults with asthma diagnosis codes and evidence of asthma medication use were studied. Patients with high OCS use (≥30 days of OCS annually were divided into those who did versus those who did not experience OCS-related possible side effects. Their health care resource use and costs were compared using linear regression or negative binomial regression models, adjusting for age, sex, geographic region, Charlson Comorbidity Index score, and chronic obstructive pulmonary disease status.Results: After adjustment, high OCS users with possible side effects were more likely to have office visits (23.0 vs 19.6; P<0.001 and hospitalizations (0.44 vs 0.22; P<0.001 than those without possible side effects. Emergency department visits were similar between the groups. High OCS users with possible side effects had higher adjusted total annual mean health care costs ($25,168 than those without such side effects ($21,882; P=0.009.Conclusion: Among high OCS users, patients with possible OCS-related side effects are more likely to use health care services than those without such side effects. Although OCS may help control asthma and manage exacerbations, OCS side effects may result in additional health care resource use and costs, highlighting the need

  19. Paranormal health claims.

    Science.gov (United States)

    Skrabanek, P

    1988-04-15

    Faith in paranormal cures has always been the last hope of many sufferers from chronic or incurable diseases. Magico-religious rituals of healing are still around, but some have been replaced by pseudo-scientific systems, thinly disguising old superstitions in new obscurantism, more appealing to the half-educated. In medical quackery, inventiveness seems to be limitless, and only the main paranormal healing systems can be reviewed here. The increasing popularity of 'alternative' healing indicates the extent of dissatisfaction with dehumanising aspects of modern, technological medicine and its preoccupation with curing the curable at the expense of caring for the incurable. This leaves the sufferers, and also healthy people labelled with non-existent diseases, bleeding prey for the sharks roving the seas of medical ignorance.

  20. Miracle Health Claims

    Science.gov (United States)

    ... arthritis The Federal Trade Commission (FTC), the nation’s consumer protection agency, and the Food and Drug Administration (FDA) ... The Federal Trade Commission (FTC) is the nation’s consumer protection agency. The FTC works to prevent fraudulent, deceptive ...

  1. Consumer Health: CAM Claims

    Science.gov (United States)

    ... htm Accessed June 8, 2017. Rakel D, ed. Philosophy of integrative medicine. In: Integrative Medicine. 4th ed. ... Rochester, Minn.: Mayo Foundation for Medical Education and Research; 2018. June 09, 2018 Original article: http://www. ...

  2. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to glucose and contribution to energy-yielding metabolism pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Dextro Energy GmbH & Co. KG, 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...

  3. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to glucose and contribution to energy-yielding metabolism pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Dextro Energy GmbH & Co. KG 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...

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

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following an application from Roxlor Nutra LLC, 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...

  5. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of lycopene, vitamin E, lutein and selenium and “ helps to prepare and activate tannin g ” 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 Cyprus, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health clai...

  6. 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.

  7. 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

  8. 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.

  9. Sports-related injuries in New Zealand: National Insurance (Accident Compensation Corporation) claims for five sporting codes from 2012 to 2016.

    Science.gov (United States)

    King, Doug; Hume, Patria A; Hardaker, Natalie; Cummins, Cloe; Gissane, Conor; Clark, Trevor

    2018-03-12

    To provide epidemiological data and related costs for sport-related injuries of five sporting codes (cricket, netball, rugby league, rugby union and football) in New Zealand for moderate-to-serious and serious injury claims. A retrospective analytical review using detailed descriptive epidemiological data obtained from the Accident Compensation Corporation (ACC) for 2012-2016. Over the 5 years of study data, rugby union recorded the most moderate-to-serious injury entitlement claims (25 226) and costs (New Zealand dollars (NZD$)267 359 440 (£139 084 749)) resulting in the highest mean cost (NZD$10 484 (£5454)) per moderate-to-serious injury entitlement claim. Rugby union recorded more serious injury entitlement claims (n=454) than cricket (t (4) =-66.6; P<0.0001); netball (t (4) =-45.1; P<0.0001); rugby league (t (4) =-61.4; P<0.0001) and football (t (4) =66.6; P<0.0001) for 2012-2016. There was a twofold increase in the number of female moderate-to-serious injury entitlement claims for football (RR 2.6 (95%CI 2.2 to 2.9); P<0.0001) compared with cricket, and a threefold increase when compared with rugby union (risk ratio (RR) 3.1 (95%CI 2.9 to 3.3); P<0.0001). Moderate-to-serious concussion claims increased between 2012 and 2016 for netball (RR 3.7 (95%CI 1.9 to 7.1); P<0.0001), rugby union (RR 2.0 (95% CI 1.6 to 2.4); P<0.0001) and football (RR 2.3 (95%CI 1.6 to 3.2); P<0.0001). Nearly a quarter of moderate-to-serious entitlement claims (23%) and costs (24%) were to participants aged 35 years or older. Rugby union and rugby league have the highest total number and costs associated with injury. Accurate sport exposure data are needed to enable injury risk calculations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. 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.

  11. 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...

  12. Approaches to health assessment related to housing

    NARCIS (Netherlands)

    Guerra Santin, O.

    2006-01-01

    This research had the purpose of providing more information about possible approaches and indicators to measure indoor health in relation to housing. In researches related with health and some Life Cycle Assessment (LCA) databases, the model used for health assessment is the Impact Pathway Analysis

  13. Claiming Community

    DEFF Research Database (Denmark)

    Jensen, Steffen Bo

    As its point of departure this working paper takes the multitude of different uses and meanings of the concept of community in local politics in Cape Town. Instead of attempting to define it in substantive terms, the paper takes a social constructivist approach to the study of community...... is termed community work. First, the paper explores how community has become a governmental strategy, employed by the apartheid regime as well, although in different ways, as post-apartheid local government. Secondly, the paper explores the ways in which community becomes the means in which local residents...... lay claim on the state, as well as how it enters into local power struggles between different political groups within the township. In the third part, the paper explores how the meanings of community and the struggles to realise it have changed as South Africa, nationally and locally, has become...

  14. 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.

  15. NHRIC (National Health Related Items Code)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering...

  16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Bimuno® GOS and reducing gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

    DEFF Research Database (Denmark)

    Tetens, Inge

    the two human intervention studies which investigated the effect of Bimuno® GOS on symptoms related to gastro-intestinal discomfort. The remaining human studies, and the animal and in vitro studies, addressed the effects of either Bimuno® GOS or other galacto-oligosaccharides from a variety of sources...

  17. 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.

  18. 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.

  19. Nutrition and health claims – call for and justification of governmental intervention from the consumers’ perspective

    OpenAIRE

    Hartmann, Monika; Lensch, Anne Katrin; Simons, Johannes; Thrams, Sylvia

    2008-01-01

    In December 2006 the Regulation (EC) No. 1924/2006 on the use of nutrition and health claims (NHCs) on foods was enacted in order to prevent consumer deception and to harmonise law within the EU. Against this background, this paper analyses the potential costs and benefits linked with NHCs and the necessity for governmental intervention to regulate NHCs within a theoretical and empirical framework. The theoretical investigation shows that NHCs can induce direct economic effects as well as spi...

  20. Mundane science use in a practice theoretical perspective: Different understandings of the relations between citizen-consumers and public communication initiatives build on scientific claims.

    Science.gov (United States)

    Halkier, Bente

    2015-08-13

    Public communication initiatives play a part in placing complicated scientific claims in citizen-consumers' everyday contexts. Lay reactions to scientific claims framed in public communication, and attempts to engage citizens, have been important subjects of discussion in the literatures of public understanding and public engagement with science. Many of the public communication initiatives, however, address lay people as consumers rather than citizens. This creates specific challenges for understanding public engagement with science and scientific citizenship. The article compares five different understandings of the relations between citizen-consumers and public issue communication involving science, where the first four types are widely represented in the Public Understanding of Science discussions. The fifth understanding is a practice theoretical perspective. The article suggests how the public understanding of and engagement in science literature can benefit from including a practice theoretical approach to research about mundane science use and public engagement. © The Author(s) 2015.

  1. High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.

    Science.gov (United States)

    Kurihara, Chieko; Kusuoka, Hideo; Ono, Shunsuke; Kakee, Naoko; Saito, Kazuyuki; Takehara, Kenji; Tsujide, Kiyokazu; Nabeoka, Yuzo; Sakuhiro, Takuya; Aoki, Hiroshi; Morishita, Noriko; Suzuki, Chieko; Kachi, Shigeo; Kondo, Emiko; Komori, Yukiko; Isobe, Tetsu; Kageyama, Shigeru; Watanabe, Hiroshi

    2014-01-01

    International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.

  2. 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.

  3. Aprender de lo sucedido. Análisis de las quejas presentadas ante la Comisión Nacional de Arbitraje Médico Learning from experience. User's dissatisfaction with health services through claims brought to Conamed

    Directory of Open Access Journals (Sweden)

    Raydel Valdés-Salgado

    2001-10-01

    Full Text Available Objetivos. Describir las quejas por insatisfacción con los servicios médicos que se presentaron ante la Comisión Nacional de Arbitraje Médico (Conamed, en 1997 y 1998, procedentes de México, Distrito Federal. También, conocer qué aspectos de la calidad de la atención aparecen como deficientes, según las instituciones, las especialidades y algunas características de los quejosos. Material y métodos. Se estudiaron 1 925 quejas y se sistematizó la información para su análisis cuantitativo. Se aplicó la prueba ji cuadrada (ji² de Pearson para muestras independientes y un análisis de conglomerados. Resultados. Las quejas, principalmente, son relativas al tratamiento, las intervenciones quirúrgicas y el diagnóstico. Para cada una de las instituciones involucradas se distingue si las quejas se refieren a la estructura, al proceso o al resultado de la atención. Los tipos de conflictos difieren según el sexo, la edad y nivel socioeconómico de las personas. Conclusiones. Las quejas llevadas ante la Conamed aportan elementos sobre la satisfacción de los usuarios y la calidad de la atención; nuestros resultados son consistentes con los resultados de otros trabajos previos que han estudiado la satisfacción de los usuarios y la calidad de la atención. El texto completo en inglés de este artículo está disponible en: http://www.insp.mx/salud/index.htmlObjectives. To describe claims brought to Comisión Nacional de Arbitraje Médico (Medical Arbitration National Commission or Conamed against medical care services in Mexico City. Also, to identify deficiencies in the quality of care by institution and medical speciality and describe some characteristics of the plaintiffs. Material and Methods. A total of 1925 claims were collected and data were analysed quantitatively. Pearson's chi-square (c2 test and a cluster analysis were performed. Results. Most claims are related to therapy, surgery, and diagnosis problems. Claims related to

  4. 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.

  5. Utilization of health services in relation to mental health problems in adolescents: A population based survey

    Science.gov (United States)

    Zachrisson, Henrik D; Rödje, Kjetil; Mykletun, Arnstein

    2006-01-01

    Background Only a minority of adolescents reporting symptoms above case-levels on screenings for mental health seeks and receives help from specialist health services. The objective of this study was to a) examine help-seeking for symptoms of anxiety and depression in relation to symptom load dimensionally, b) identify the level of specialization in mental health among service-providers, and c) identify associations between mental health problems and contact with different types of health services. Methods This cross-sectional school-based study (response-rate 88%, n = 11154) is based on Norwegian health surveys among 15 and 16 year olds. Results We found a dose-response association between symptom-load and help seeking. Only 34% of individuals with mental symptom-load above 99th percentile reported help-seeking in the last 12 months. Forty percent of help seekers were in contact with specialists (psychiatrists or psychologists), the remaining were mainly in contact with GPs. Mental health problems increased help seeking to all twelve service providers examined. Conclusion It might not be reasonable to argue that all adolescents with case-level mental health problems are in need of treatment. However, concerning the 99th percentile, claiming treatment need is less controversial. Even in the Norwegian context where mental health services are relatively available and free of charge, help-seeking in individuals with the highest symptom-loads is still low. Most help seekers achieved contact with health care providers, half of them at a non specialized level. Our results suggest that adolescents' recognition of mental health problems or intention to seek help for these are the major "filters" restricting treatment. PMID:16480522

  6. Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess claims about treatment effects: a randomised controlled trial.

    Science.gov (United States)

    Semakula, Daniel; Nsangi, Allen; Oxman, Andrew D; Oxman, Matt; Austvoll-Dahlgren, Astrid; Rosenbaum, Sarah; Morelli, Angela; Glenton, Claire; Lewin, Simon; Kaseje, Margaret; Chalmers, Iain; Fretheim, Atle; Kristoffersen, Doris Tove; Sewankambo, Nelson K

    2017-07-22

    As part of the Informed Health Choices project, we developed a podcast called The Health Choices Programme to help improve the ability of people to assess claims about the benefits and harms of treatments. We aimed to evaluate the effects of the podcast on the ability of parents of primary school children in Uganda to assess claims about the effects of treatments. We did this randomised controlled trial in central Uganda. We recruited parents of children aged 10-12 years who were in their fifth year of school at 35 schools that were participating in a linked trial of the Informed Health Choices primary school resources. The parents were randomly allocated (1:1), via a web-based random number generator with block sizes of four and six, to listen to either the Informed Health Choices podcast (intervention group) or typical public service announcements about health issues (control group). Randomisation was stratified by parents' highest level of formal education attained (primary school, secondary school, or tertiary education) and the allocation of their children's school in the trial of the primary school resources (intervention vs control). The primary outcome, measured after listening to the entire podcast, was the mean score and the proportion of parents with passing scores on a test with two multiple choice questions for each of nine key concepts essential to assessing claims about treatments (18 questions in total). We did intention-to-treat analyses. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001676150. We recruited parents between July 21, 2016, and Oct 7, 2016. We randomly assigned 675 parents to the podcast group (n=334) or the public service announcement group (n=341); 561 (83%) participants completed follow-up. The mean score for parents in the podcast group was 67·8% (SD 19·6) compared with 52·4% (17·6) in the control group (adjusted mean difference 15·5%, 95% CI 12·5-18·6; pparents had a predetermined

  7. Australia's international health relations in 2003.

    Science.gov (United States)

    Barraclough, Simon

    2005-02-21

    A survey for the year 2003 of significant developments in Australia's official international health relations, and their domestic ramifications, is presented. The discussion is set within the broader context of Australian foreign policy. Sources include official documents, media reports and consultations with officers of the Department of Health and Ageing responsible for international linkages.

  8. Health Related Outcomes of Successful Development

    Czech Academy of Sciences Publication Activity Database

    Kebza, V.; Šolcová, Iva; Kodl, M.; Kernová, V.

    2016-01-01

    Roč. 24, č. 1 (2016), s. 76-82 ISSN 1210-7778 Institutional support: RVO:68081740 Keywords : successful development * longitudinal study * health -related variables Subject RIV: AN - Psychology Impact factor: 0.682, year: 2016

  9. Income-related inequality in health and health-related behaviour: exploring the equalisation hypothesis

    OpenAIRE

    Vallejo-Torres, Laura; Hale, Daniel; Morris, Stephen; Viner, Russell M

    2014-01-01

    Background Previous studies have found the socioeconomic gradient in health among adolescents to be lower than that observed during childhood and adulthood. The aim of this study was to examine income-related inequalities in health and health-related behaviour across the lifespan in England to explore ‘equalisation’ in adolescence. Methods We used five years of data (2006–2010) from the Health Survey for England to explore inequalities in six indicators: self-assessed general health, longstan...

  10. [Rehabilitation in geriatric patients after ischemic stroke--a comparison of 2 organisational systems in Germany using claims data of a statutory health insurance fund].

    Science.gov (United States)

    Abbas, S; Ihle, P; Hein, R; Schubert, I

    2013-12-01

    Due to historical aspects in some federal states in Germany rehabilitation of geriatric patients is organized in geriatric departments in hospitals (§ 109 SGB V). In other states rehabilitation of these patients is mainly realized in geriatric rehabilitation facilities outside hospital care after approval by the health insurance (§ 111 SGB V). Thus, it is of interest to compare both types of health care with respect to differences in population characteristics, resource utilization and outcome parameters (i.e., excess costs, rehospitalization, fracture risk and mortality) using a common geriatric indication, the ischemic stroke, as an example. Claims data of the AOK (Local Health Care Fund) from seven federal states in Germany were used. Insured persons with a documented hospital stay with discharge diagnosis cerebral infarction/stroke (ICD-10 I63, I64, below denoted by "ischemic stroke") in 2007 (N=39,887) were included and allocated to the respective form of rehabilitative health care via the OPS (German procedure classification for inpatient procedures) procedure 8-550 (§ 109, N=1,272) or via admission to a geriatric rehabilitation unit within 1 month after hospital discharge (§ 111, N=2,200). All direct costs were ascertained and presented with and without costs of long-term care. Excess costs were calculated as the difference of costs between the first year after insult and the costs in the previous year. Excess costs in the 2 types of care were compared using multivariate quantile regression analysis. Risk of hospitalization (due to ischemic stroke or fracture) and risk of death in a 1-year follow-up was analysed using multivariate cox regression. Insured members treated according to health care type § 109 were somewhat older (mean: 81 vs. 80 years of age), more frequently female (72 vs. 67%), more often receiving long-term care (27 vs. 19%) and had more often documented sequelae after insult (>=4 diseases 39 vs. 28%). No significant differences in

  11. 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.

  12. Health related smartphone applications: a literature review

    Directory of Open Access Journals (Sweden)

    Pantelis Stergiannis

    2015-09-01

    Full Text Available The rapid evolution of technology, has offered access to a variety of applications and technologies to healthcare professionals. New operating systems developed in the field of mobile devices revolutionized the way in which they are used. One of the main features offered by advanced software of a smartphone is the user’s access to a wealth of new, impressive applications across several operating systems for smartphones. The health related applications provided through smartphones, promote more active involvement of patients and healthcare professionals to provided care and are a new tool for improving health. The purpose of this abstract paper or article was to refer to applications currently used in the health sector, indicating specific capabilities they offer through review of electronic literature, focusing on scientific articles published in databases (PubMed, Scopus, etc. referring to the potentials they offer. It seems that several health related applications have been developed, that can be classified into two main categories. One category comprises applications that are informative, i.e. provide information to the user about health issues, allowing a person to read, gather resources to make decisions, but also to introduce its own data. These applications are mostly used by health care professionals. The second major category of applications refers to those related to help with the diagnosis, treatment and decision-making on various health related issues and in some cases take the form of consultancy, substituting the health care professional. As technology advances, the development of new health related applications is expected, specialized, with new features. Finally, the use of such applications by health care professionals is essential.

  13. 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.

  14. 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...

  15. 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…

  16. Are systemizing and autistic traits related to talent and interest in mathematics and engineering? Testing some of the central claims of the empathizing-systemizing theory.

    Science.gov (United States)

    Morsanyi, Kinga; Primi, Caterina; Handley, Simon J; Chiesi, Francesca; Galli, Silvia

    2012-11-01

    In two experiments, we tested some of the central claims of the empathizing-systemizing (E-S) theory. Experiment 1 showed that the systemizing quotient (SQ) was unrelated to performance on a mathematics test, although it was correlated with statistics-related attitudes, self-efficacy, and anxiety. In Experiment 2, systemizing skills, and gender differences in these skills, were more strongly related to spatial thinking styles than to SQ. In fact, when we partialled the effect of spatial thinking styles, SQ was no longer related to systemizing skills. Additionally, there was no relationship between the Autism Spectrum Quotient (AQ) and the SQ, or skills and interest in mathematics and mechanical reasoning. We discuss the implications of our findings for the E-S theory, and for understanding the autistic cognitive profile. ©2011 The British Psychological Society.

  17. Use of major surgery in south India: A retrospective audit of hospital claim data from a large, community health insurance program.

    Science.gov (United States)

    Shaikh, Maaz; Woodward, Mark; Rahimi, Kazem; Patel, Anushka; Rath, Santosh; MacMahon, Stephen; Jha, Vivekanand

    2015-05-01

    Information on the use of major surgery in India is scarce. In this study we aimed to bridge this gap by auditing hospital claims from Rajiv Aarogyasri Community Health Insurance Scheme, which provides access to free hospital care through state-funded insurance to 68 million beneficiaries, an estimated 81% of population in the states of Telangana and Andhra Pradesh. Publicly available deidentified hospital claim data for all surgery procedures conducted between mid-2008 and mid-2012 were compiled across all 23 districts in Telangana and Andhra Pradesh. A total of 677,332 operative admissions (80% at private hospitals) were recorded at an annual rate of 259 per 100,000 beneficiaries, with male subjects accounting for 56% of admissions. Injury was the most common cause for operative admission (27%) with operative correction of long bone fractures being the most common procedure (20%) identified in the audit. Diseases of the digestive (16%), genitourinary (12%), and musculoskeletal (10%) systems were other leading causes for operative admissions. Most hospital bed-days were used by admissions for injuries (31%) and diseases of the digestive (17%) and musculoskeletal system (11%) costing 19%, 13%, and 11% of reimbursement. Operations on the circulatory system (8%) accounted for 21% of reimbursements. Annual per capita cost of operative claims was US$1.48. The use of surgery by an insured population in India continued to be low despite access to financing comparable with greater spending countries, highlighting need for strategies, beyond traditional health financing, that prioritize improvement in access, delivery, and use of operative care. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Exploring the small-scale spatial distribution of hypertension and its association to area deprivation based on health insurance claims in Northeastern Germany.

    Science.gov (United States)

    Kauhl, B; Maier, W; Schweikart, J; Keste, A; Moskwyn, M

    2018-01-10

    Hypertension is one of the most frequently diagnosed chronic conditions in Germany. Targeted prevention strategies and allocation of general practitioners where they are needed most are necessary to prevent severe complications arising from high blood pressure. However, data on chronic diseases in Germany are mostly available through survey data, which do not only underestimate the actual prevalence but are also only available on coarse spatial scales. The discussion of including area deprivation for planning of healthcare is still relatively young in Germany, although previous studies have shown that area deprivation is associated with adverse health outcomes, irrespective of individual characteristics. The aim of this study is therefore to analyze the spatial distribution of hypertension at very fine geographic scales and to assess location-specific associations between hypertension, socio-demographic population characteristics and area deprivation based on health insurance claims of the AOK Nordost. To visualize the spatial distribution of hypertension prevalence at very fine geographic scales, we used the conditional autoregressive Besag-York-Mollié (BYM) model. Geographically weighted regression modelling (GWR) was applied to analyze the location-specific association of hypertension to area deprivation and further socio-demographic population characteristics. The sex- and age-adjusted prevalence of hypertension was 33.1% in 2012 and varied widely across northeastern Germany. The main risk factors for hypertension were proportions of insurants aged 45-64, 65 and older, area deprivation and proportion of persons commuting to work outside their residential municipality. The GWR model revealed important regional variations in the strength of the examined associations. Area deprivation has only a significant and therefore direct influence in large parts of Mecklenburg-West Pomerania. However, the spatially varying strength of the association between demographic

  19. Employees notified with work-related mental disorder calls for workplace interventions, but are left behind with a demanding insurance claim

    DEFF Research Database (Denmark)

    Ladegaard, Yun Katrine; Skakon, Janne; Netterstrøm, Bo

    , including a State auditing office report on WEA’s psychosocial work environment inspections. Results indicate that employees’ motivation in notifying a work-related mental disorder, mainly represents a wish to initiate primary prevention at the work place, and the notification is often encouraged by health...... of work related mental health disorder by the healthcare systems respectively by the NBII, Overall this leave the question whether work-related mental health disorders fit into the Danish Workers compensation System?...

  20. Public relations effectiveness in public health institutions.

    Science.gov (United States)

    Springston, Jeffrey K; Weaver Lariscy, Ruth Ann

    2005-01-01

    This article explores public relations effectiveness in public health institutions. First, the two major elements that comprise public relations effectiveness are discussed: reputation management and stakeholder relations. The factors that define effective reputation management are examined, as are the roles of issues and crisis management in building and maintaining reputation. The article also examines the major facets of stakeholder relations, including an inventory of stakeholder linkages and key audiences, such as the media. Finally, methods of evaluating public relations effectiveness at both the program level and the institutional level are explored.

  1. Smart health and innovation: facilitating health-related behaviour change.

    Science.gov (United States)

    Redfern, J

    2017-08-01

    Non-communicable diseases (NCD) are the leading cause of death globally. Smart health technology and innovation is a potential strategy for increasing reach and for facilitating health behaviour change. Despite rapid growth in the availability and affordability of technology there remains a paucity of published and robust research in the area as it relates to health. The objective of the present paper is to review and provide a snapshot of a variety of contemporary examples of smart health strategies with a focus on evidence and research as it relates to prevention with a CVD management lens. In the present analysis, five examples will be discussed and they include a physician-directed strategy, consumer directed strategies, a public health approach and a screening strategy that utilises external hardware that connects to a smartphone. In conclusion, NCD have common risk factors and all have an association with nutrition and health. Smart health and innovation is evolving rapidly and may help with diagnosis, treatment and management. While on-going research, development and knowledge is needed, the growth of technology development and utilisation offers opportunities to reach more people and achieve better health outcomes at local, national and international levels.

  2. 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.

  3. Health-Related Quality of Life

    DEFF Research Database (Denmark)

    Linde, Louise; Sørensen, Jan; Ostergaard, Mikkel

    2008-01-01

    OBJECTIVE: To compare validity, reliability, and responsiveness of generic and disease specific health-related quality of life (HRQOL) instruments in rheumatoid arthritis (RA). METHODS: Two samples of patients completed the Medical Outcomes Study Short Form-36 Health Survey (SF-36), EuroQol (EQ)-5D......, 15D, Rheumatoid Arthritis Quality of Life Scale (RAQoL), Health Assessment Questionnaire (HAQ), and visual analog scales (VAS) for pain, fatigue, and global RA. Validity (convergent, discriminant, and known-groups) was evaluated in a cross-section of 200 patients. Reliability was evaluated...

  4. 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.

  5. 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...

  6. 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...

  7. 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

  8. 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...

  9. Powerful Concepts in Global Health Comment on “Knowledge, Moral Claims and the Exercise of Power in Global Health”

    Directory of Open Access Journals (Sweden)

    Eivind Engebretsen

    2015-02-01

    Full Text Available In this paper we emphasize the importance of questioning the global validity of significant concepts underpinning global health policy. This implies questioning the concept of global health as such and accepting that there is no global definition of the global. Further, we draw attention to ‘quality’ and ‘empowerment’ as examples of world-forming concepts. These concepts are exemplary for the gentle and quiet forms of power that underpin our reasoning within global health.

  10. How does age affect the care dependency risk one year after stroke? A study based on claims data from a German health insurance fund.

    Science.gov (United States)

    Schnitzer, Susanne; von dem Knesebeck, Olaf; Kohler, Martin; Peschke, Dirk; Kuhlmey, Adelheid; Schenk, Liane

    2015-10-23

    The objective of this study is to investigate the effect of age on care dependency risk 1 year after stroke. Two research questions are addressed: (1) How strong is the association between age and care dependency risk 1 year after stroke and (2) can this association be explained by burden of disease? The study is based on claims data from a German statutory health insurance fund. The study population was drawn from all continuously insured members with principal diagnoses of ischaemic stroke, hemorrhagic stroke, or transient ischaemic attack in 2007 who survived for 1 year after stroke and who were not dependent on care before their first stroke (n = 2864). Data were collected over a 1-year period. People are considered to be dependent on care if they, due to a physical, mental or psychological illness or disability, require substantial assistance in carrying out activities of daily living for a period of at least 6 months. Burden of disease was assessed by stroke subtype, history of stroke, comorbidities as well as geriatric multimorbidity. Regression models were used for data analysis. 21.6 % of patients became care dependent during the observation period. Post-stroke care dependency risk was significantly associated with age. Relative to the reference group (0-65 years), the odds ratio of care dependency was 11.30 (95 % CI: 7.82-16.34) in patients aged 86+ years and 5.10 (95 % CI: 3.88-6.71) in patients aged 76-85 years. These associations were not explained by burden of disease. On the contrary, age effects became stronger when burden of disease was included in the regression model (by between 1.1 and 28 %). Our results show that age has an effect on care dependency risk that cannot be explained by burden of disease. Thus, there must be other underlying age-dependent factors that account for the remaining age effects (e.g., social conditions). Further studies are needed to explore the causes of the strong age effects observed.

  11. 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

  12. Utilization and Expenditure of Hospital Admission in Patients with Autism Spectrum Disorder: National Health Insurance Claims Database Analysis

    Science.gov (United States)

    Lin, Jin-Ding; Hung, Wen-Jiu; Lin, Lan-Ping; Lai, Chia-Im

    2011-01-01

    There were not many studies to provide information on health access and health utilization of people with autism spectrum disorders (ASD). The present study describes a general profile of hospital admission and the medical cost among people with ASD, and to analyze the determinants of medical cost. A retrospective study was employed to analyze…

  13. 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...

  14. [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.

  15. IBO Claim Taking Project

    Data.gov (United States)

    Social Security Administration — IBO manually tracks all Canadian Claims and DSU claims via this report. It also provides a summary for each region and office of origin that the DSU works with. This...

  16. Workers Compensation Claim Data -

    Data.gov (United States)

    Department of Transportation — This data set contains DOT employee workers compensation claim data for current and past DOT employees. Types of data include claim data consisting of PII data (SSN,...

  17. FHI LFC24, a bovine milk-derived casein hydrolysate, and a reduction of post-prandial blood glucose responses: 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

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

  18. DoD Did Not Negotiate Rates With Overseas Health Care Providers and Generally Paid Claims as Billed

    Science.gov (United States)

    2014-04-01

    another important benefit, and one that has far outpaced inflation .” Health care is an area that presents opportunities to help control costs. No Process...that received health care, coupled with health care inflation . The Assistant Secretary stated that Japanese providers are not willing to negotiate...South Africa 149,069 322,275 265,951 215,898 44.8 Peru 169,117 304,765 158,656 184,005 8.8 El Salvador 113,447 171,692 123,553 182,792 61.1 Bahamas

  19. The effect of pre-existing health conditions on the cost of recovery from road traffic injury: insights from data linkage of medicare and compensable injury claims in Victoria, Australia.

    Science.gov (United States)

    Hassani-Mahmooei, Behrooz; Berecki-Gisolf, Janneke; Hahn, Youjin; McClure, Roderick J

    2016-04-29

    Comorbidity is known to affect length of hospital stay and mortality after trauma but less is known about its impact on recovery beyond the immediate post-accident care period. The aim of this study was to investigate the role of pre-existing health conditions in the cost of recovery from road traffic injury using health service use records for 1 year before and after the injury. Individuals who claimed Transport Accident Commission (TAC) compensation for a non-catastrophic injury that occurred between 2010 and 2012 in Victoria, Australia and who provided consent for Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) linkage were included (n = 738) in the analysis. PBS and MBS records dating from 12 months prior to injury were provided by the Department of Human Services (Canberra, Australia). Pre-injury use of health service items and pharmaceuticals were considered to indicate pre-existing health condition. Bayesian Model Averaging techniques were used to identify the items that were most strongly correlated with recovery cost. Multivariate regression models were used to determine the impact of these items on the cost of injury recovery in terms of compensated ambulance, hospital, medical, and overall claim cost. Out of the 738 study participants, 688 used at least one medical item (total of 15,625 items) and 427 used at least one pharmaceutical item (total of 9846). The total health service cost of recovery was $10,115,714. The results show that while pre-existing conditions did not have any significant impact on the total cost of recovery, categorical costs were affected: e.g. on average, for every anaesthetic in the year before the accident, hospital cost of recovery increased by 24 % [95 % CI: 13, 36 %] and for each pathological test related to established diabetes, hospital cost increased by $10,407 [5466.78, 15346.28]. For medical costs, each anaesthetic led to $258 higher cost [174.16, 341.16] and every prescription of drugs

  20. Associations between health culture, health behaviors, and health-related outcomes: A cross-sectional study.

    Science.gov (United States)

    Jia, Yingnan; Gao, Junling; Dai, Junming; Zheng, Pinpin; Fu, Hua

    2017-01-01

    To examine the associations between demographic characteristics, health behaviors, workplace health culture, and health-related outcomes in Chinese workplaces. A total of 1508 employees from 10 administrative offices and 6 enterprises were recruited for a cross-sectional survey. Self-administered questionnaires mainly addressed demographic characteristics, health behaviors, workplace health culture, and health-related outcomes including self-rated health, mental health, and happiness. The proportion of participants who reported good health-related outcomes was significantly higher in those working in administrative offices than those working in enterprises. The result of the potential factors related to self-rated health (SRH), mental health, and happiness by logistic regression analyses showed that age and income were associated with SRH; type of workplace, age, smoking, and health culture at the workplace level were associated with mental health; and beneficial health effects of direct leadership was positively associated with happiness. Moreover, there were some similar results among 3 multivariate regression models. Firstly, good SRH (Odds Ratio (OR) = 1.744), mental health (OR = 1.891), and happiness (OR = 1.736) were more common among highly physically active participants compared with those physical inactive. Furthermore, passive smoking was negatively correlated with SRH (OR = 0.686), mental health (OR = 0.678), and happiness (OR = 0.616), while health culture at the individual level was positively correlated with SRH (OR = 1.478), mental health (OR = 1.654), and happiness (OR = 2.916). The present study indicated that workplace health culture, health behaviors, and demographic characteristics were associated with health-related outcomes. Furthermore, individual health culture, physical activity, and passive smoking might play a critical role in workplace health promotion.