Building Linked Big Data for Stroke in Korea: Linkage of Stroke Registry and National Health Insurance Claims Data

BACKGROUND: Linkage of public healthcare data is useful in stroke research because patients may visit different sectors of the health system before, during, and after stroke. Therefore, we aimed to establish high-quality big data on stroke in Korea by linking acute stroke registry and national health claim databases. METHODS: Acute stroke patients (n = 65,311) with claim data suitable for linkage were included in the Clinical Research Center for Stroke (CRCS) registry during 2006–2014. We linked the CRCS registry with national health claim databases in the Health Insurance Review and Assessment Service (HIRA). Linkage was performed using 6 common variables: birth date, gender, provider identification, receiving year and number, and statement serial number in the benefit claim statement. For matched records, linkage accuracy was evaluated using differences between hospital visiting date in the CRCS registry and the commencement date for health insurance care in HIRA. RESULTS: Of 65,311 CRCS cases, 64,634 were matched to HIRA cases (match rate, 99.0%). The proportion of true matches was 94.4% (n = 61,017) in the matched data. Among true matches (mean age 66.4 years; men 58.4%), the median National Institutes of Health Stroke Scale score was 3 (interquartile range 1–7). When comparing baseline characteristics between true matches and false matches, no substantial difference was observed for any variable. CONCLUSION: We could establish big data on stroke by linking CRCS registry and HIRA records, using claims data without personal identifiers. We plan to conduct national stroke research and improve stroke care using the linked big database.

Differences on the Regulation between Foods with Health Claims and Ethical Pharmaceuticals from the Viewpoint of Regulatory Science / 日本補完代替医療学会誌

Currently, self-medication, including the use of foods with health claims (FHCs), is promoted as means of increasing our health span. However, the functional substance(s) in FHCs and its actions are diverse, and therefore it is difficult to evaluate their safety and efficacy in clinical trials. In this review article, we describe the definition and the history of regulations regarding FHCs. After discussing their types and features, we explain the differences on regulations between FHCs and ethical pharmaceuticals regarding their safety and efficacy in clinical trials, which are required to provide them with scientific evidence. Finally, we believe that transparent standards regarding the evaluation of FHCs would help increase the use of FHCs and their market value in the future.

A study of consumers' perceptions and prediction of consumption patterns for generic health functional foods

The Korea Food and Drug Administration (KFDA) revised the Health Functional Food Act in 2008 and extended the form of health functional foods to general food types. Therefore, this study was performed to investigate consumers' perceptions of the expanded form of health functional food and to predict consumption patterns. For this study, 1,006 male and female adults aged 19 years and older were selected nationwide by multi-stage stratified random sampling and were surveyed in 1:1 interviews. The questionnaire survey was conducted by Korea Gallup. The subjects consisted of 497 (49.4%) males and 509 (50.6%) females. About 57.9% of the subjects recognized the KFDA's permission procedures for health functional foods. Regarding the health functional foods that the subjects had consumed, red ginseng products were the highest (45.3%), followed by nutritional supplements (34.9%), ginseng products (27.9%), lactobacillus-containing products (21.0%), aloe products (20.3%), and Japanese apricot extract products (18.4%). Opinions on expanding the form of health functional foods to general food types scored 4.7 points on a 7-point scale, showing positive responses. In terms of the effects of medicine-type health functional foods versus generic health functional foods, the highest response was 'same effects if the same ingredients are contained' at a rate of 34.7%. For intake frequency by food type, the response of 'daily consistent intake' was 31.7% for capsules, tablets, and pills, and 21.7% for extracts. For general food types, 'daily consistent intake' was 44.5% for rice and 22.8% for beverages, which were higher rates than those for medicine types. From the above results, consumers had positive opinions of the expansion of health functional foods to generic forms but are not expected to maintain accurate intake frequencies or amounts. Thus, continuous promotion and education are needed for proper intake of generic health functional foods.

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

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

Permission of Foods for Specified Health Use (FOSHU) / 日本補完代替医療学会誌

The category “Food with Health Claim” contains “Food with Nutrient Function Claim” and “Food for Specified Health Use (FOSHU)”. The definition of “Food with Nutrient Function Claim” is “food used to supplement nutritional factors such as vitamins and minerals”. Once certain standards have been met, public sale of the item is possible. In concrete terms these requirements specify that the daily intake of the aforementioned nutritional factors must be within a certain range, as well as the display of health claims and warning labels.<br> At the same time, because FOSHU possess components capable of affecting physiological function, and their application is essentially as specific health foods, each food to be sold as FOSHU requires authorization from the Japanese Ministry of Health. In this article we focus on the various tests required for approval.<br>

International Comparison of Health Claim on Foods and the Scientific Evidence / 日本補完代替医療学会誌

The Japanese regulatory system of "Foods for Specified Health Use (FOSHU)" was set up to approve the statements made on food labels concerning the effect of the food on the human body in 1991 and that of "Foods with Nutrient Function Claims (FNFC)" standardized the nutrient function claims of vitamins and minerals in 2001. The International guideline of the Nutrient Function Claim, the Other Functional Claim and the Disease Risk Reduction Claims were adopted by the Codex Committee in 2004. The Structure/Function Claim, which is similar to the Other Function Claim, was enacted by the Dietary Supplement Health and Education Act in the U.S in 1994. Most of the statements of the Japanese FOSHU are close to the category of Structure/Function Claims in the U.S. or the Other function claim in Codex. The health claim on foods should always be based on scientific evidence and be in harmony with international standards.<br>