Korean Healthcare Research Articles

Conducting and Reporting a Clinical Research Using Korean Healthcare Claims Database.

An increasing number of studies are using healthcare claims databases to assess healthcare intervention utilization patterns or outcomes in real-world clinical settings. However, methodological issues affecting study design or data analysis can make conducting and reporting these types of studies difficult. This review presents an overview of the types of information contained in claims data, describes some advantages and limitations of using claims data for research purposes, and outlines steps for utilizing the Korea Health Insurance Review and Assessment and National Health Insurance Service databases. The study also reviews epidemiological approaches utilizing healthcare claims databases (including cross-sectional, case-control, case-crossover, and cohort designs) with respect to protocol development, analysis, and reporting of results, and introduces relevant guidelines and checklists, including the Guidelines for Good Pharmacoepidemiology Practices, the Strengthening the Reporting of Observational Studies in Epidemiology checklist, and the Risk of Bias in Nonrandomized Studies of Interventions tool.

The Influential Factors of Health Care Customer Loyalty: Evidence from Serbia

Research question: This study aims to investigate the determinants of customer loyalty in a European emerging economy’s health care setting. Motivation: In spite of a rising research interest in the determinants of patients’ loyalty over previous years, scarce attention has been paid to date to simultaneous examination of the influential factors of patients’ loyalty. Although a number of studies have pointed to patients’ perceptions of service quality as an important determinant of loyalty, there is a paucity of research of the impact of service quality, at a disaggregate level, on patients’ loyalty. Idea: To address this knowledge gap, this study builds upon the South Korean health care service quality measurement instrument and, upon supporting its validity in the Serbian health care setting, examines a relative contribution of service quality dimensions and satisfaction to patients’ loyalty. Data: Quantitative research has been performed, by means of a structured questionnaire, on a convenience sample of 300 health care customers in Serbia. Tools: Structural equation modelling (SEM) has been applied to simultaneously examine the impact of service quality dimensions and satisfaction on patients’ loyalty. Findings: Results of the study point to patient satisfaction as the most significant determinant of loyalty, followed by tangibles and concern of other medical staff, which in terms of total effect resulted as statistically significant determinants of loyalty. Findings of this study indicate that managerial attention to these predictors may results in higher levels of patients’ loyalty to the institution. Contribution: This study adds to the body of knowledge on patients’ loyalty and points to the relevance of a more holistic approach in future examinations of customer loyalty in a health care setting.

Introduction of a Borderline Range for the Interpretation of QuantiFERON-TB Gold In-Tube Results in Korean Healthcare Workers

South Korea is the only Organisation for Economic Co-operation and Development (OECD) country with a high incidence of tuberculosis (TB). Healthcare workers (HCWs) have an increased risk of TB infection. QuantiFERON-TB Gold In-Tube (QFT-GIT) testing is performed for occupational health screening to detect latent TB infection (LTBI). We evaluated the introduction of new criteria for borderline ranges for interferon-gamma release assay (IGRA) results in HCWs. The results of QFT-GIT tests in HCWs in 2017 and 2018 were collected, with high-risk HCWs having two serial test results. Existing dichotomous criteria and new criteria with borderline ranges (bor-derline negative [BN], 0.20 - 0.34 IU/mL; borderline positive [BP], 0.35 - 0.99 IU/mL) were applied to each test re-sult. After applying the borderline range, 26.4% of the positive results were classified as BP (4% of total results), while 4.2% of the negative results were classified as BN (3.6% of total results). Among seven HCWs with initial results in the borderline range, two had repeated borderline results while 71.4% had low negative results. We recommend the introduction of borderline ranges in the interpretation of QFT-GIT results to reduce unnecessary TB therapy in HCWs.

Survey of physicians' views on the clinical implementation of pharmacogenomics-based personalized therapy.

Despite quantitative increases and qualitative advances in pharmacogenomics (PGx) research, the clinical implementation of PGx-based personalized therapy has still been limited. The objective of this study was to assess physicians' self-reported knowledge of PGx-based personalized therapy, and to explore the most problematic and highest priority barriers preventing physicians from applying PGx into clinical practice under the Korean healthcare system. A 36-question survey was distributed to 53 physicians with various specialties in Korea. In the physicians' self-perceived knowledge, twenty-eight physicians (53%) reported a lack sufficient knowledge about PGx. The perceived largest barrier to clinical implementation of PGx was the high cost of PGx testing, followed by a lack of PGx education for healthcare providers or lack of clinical PGx experts. Physicians without clinical PGx experience or with indirect experience reported that the largest barrier to clinical implementation of PGx was the high cost of PGx testing, while physicians with clinical PGx experience pointed out that a lack of patients' education was the major concern, followed by a lack of PGx education for healthcare providers or lack of clinical PGx experts. The highest priority problem was reported to be a lack of actionable guidelines for drug selection and dosing using PGx. In conclusion, we should increase and expand extensive educational programs for healthcare providers and patients, and to develop and establish a clinical decision support systems for PGx-based personalized therapy in Korea.

Current status and future of internal medicine hospitalist in Korea

A hospitalist system was introduced in Korea in September in 2016 to improve the quality of in-patient care and to cope with the shortage of medical residents. This study aimed to outline the current situation of internal medicine hospitalist and to suggest a development strategy. By May 2019, the number of hospitalists in Korea had increased to 124. Patient safety issues, resident law, and the shortage of medical residents has led to an increase in the demand for hospitalists in Korea. Internal medicine hospitalist care in Korea has been associated with patient satisfaction, length of stay, and waiting time in emergency departments. There are three different hospitalist ward models in the Korean health care system, and each hospital needs the model that fits its specific situation. In the general ward model, the role of the hospitalist is similar to that of the chief residents because the wards are categorized into nine subspecialty areas, such as internal medicine (including gastroenterology, pulmonology, and cardiology). In the short-term admission ward model, patients are usually turned around within 72 hours; therefore, the hospitalist is able to care for patients independently. After that, patients are discharged or admitted to a specialty ward. In integrated care model, patients from all specialty areas are admitted to the same ward; therefore, hospitalists care for patients independently. In this model, consultation with specialists is required. There were strengths and weaknesses in each model. Therefore, the models should be considered based on the hospital's function. This study found some problems in the present hospitalist system, including undefined roles and responsibilities, unclear future employment prospects, burnout due to patient' severity of illness, and inadequate payment systems for weekend and night work. To further develop the hospitalists system in Korea, the Korean government, the Korean associated of internal medicine, hospitals, and hospitalists must work together to solve the present problems.

SUCCESSFUL AGING AND HEALTHCARE SERVICE UTILIZATION IN EAST ASIA: NATIONAL COMPARISONS OF CHINA, KOREA, AND JAPAN

As the older population increases and lives longer, the demand for healthcare has been increased dramatically. To date, it is unknown whether older people’s healthcare utilization varies between countries and how it relates to successful aging. Using Rowe and Kahn’s model, we examine cross-national differences in the relationship between successful aging and healthcare service utilization in East Asia. Harmonized datasets at baseline from China Health and Retirement Longitudinal Study (CHARLS), Korean Longitudinal Study (KLoSA), and Japanese Study on Aging and Retirement (JSTAR) were used. Including 7,651 participants (aged 65-75 years), successful agers were identified using Rowe and Kahn’s criteria (i.e., no disease, no disability, high cognitive function, and active engagement). Healthcare service utilization includes hospital visit, number of hospital stay, number of nights per hospital stay, regular medical center visit, number of medical center visits, and possession of private insurance in previous year. Generalized linear models showed that successful agers’ healthcare service utilization is significantly different from non-successful agers (e.g., OR=2.19, p<.001 for regular medical center visits), and Korean and Chinese healthcare service utilization is different from Japanese (e.g., OR=0.44 and OR=10.18 for Chinese and Korean number of medical center regular visits, respectively, p<.001). Furthermore, the number of nights in hospital among Chinese and Korean successful agers tend to be greater than that of Japanese successful agers (OR=2.93 and OR=1.99 for Chinese and Korean successful agers, respectively, p<.001). This study indicates cross-national variations in pattern of healthcare service utilization between successful and non-successful agers in East Asia.

PCV145 ASSOCIATION BETWEEN NICORANDIL AND GASTROINTESTINAL ULCERS: A POPULATION-BASED STUDY

The association between nicorandil (NCR) use, an antianginal drug, and the risk of gastrointestinal (GI) ulcers was evaluated in angina patients using Korean healthcare big data. A cross-sectional study was conducted using 2014 HIRA-NPS data including patients aged 40 years or more. A 3-month washout period was placed to identify new drug users and incident safety outcomes. A new NCR user was captured from a 3-month follow-up period followed by a 6-month period for detecting the safety outcome of GI ulcer. The association between NCR use and GI ulcers was evaluated using multivariate logistic regression analysis. The study population included 1,767 nicorandil users representing 58,900 Korean patients. Of the nicorandil users, 4,667 (8%) patients were reported to have one or more of GI ulcers as an adverse drug reactions (ADR). As compared to other anti-anginal medications including molsidomine, trimetazidine, nitrates, and calcium channel blockers, NCR was not found to increase the risk of GI ulcer (adjusted odds ratio [aOR] 1.119; 95% CI: 0.607 – 2.064) after adjusting confounders including age, sex, insurance type, and clinical comorbidities of diabetes, inflammatory bowel diseases, and any types of cancer. Among concurrent medications including corticosteroids, bisphosphonates, aspirin, anti-platelet agents, selective serotonin reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs), only corticosteroids (aOR 1.615; 95% CI: 1.124 – 2.319) and NSAIDs (aOR 1.776; 95% CI: 1.125 – 2.803) significantly increased the risk of GI ulcers. Using a 1-year real-world data available from the Korean healthcare insurance system, NCR did not significantly increase the risk of GI ulcers as compared to other anti-anginal medications. As the study only allowed a 6-month follow-up and the standard regimen did not exceed 15mg per day, which was lower than the ADR reported dosage of 60mg or higher, further research including longitudinal follow-ups and other real-world data are needed.

1209. Seroprevalence of Measles, Mumps, and Rubella in Korean Healthcare Workers and Strategy for Vaccination

BackgroundThe measles, mumps, and rubella (MMR) vaccination to children was accelerated in South Korea as the National Immunization Programs in 1985. A two-dose MMR vaccination schedule was introduced in 1997. However, outbreaks of measles in healthcare institution continued to occur. Recent studies revealed that the seroprevalence of measles in healthcare workers (HCWs) was approximately 40–60% in twentieth. The purpose of this study was to determine the seroprevalence of MMR antibodies in HCWs to establish strategy for vaccination.MethodsTo prevent nosocomial transmission of measles, test for MMR antibody of HCWs was conducted in three teaching hospitals from January to February in 2019. The testing was conducted only in the patient contact departments. We excluded HCWs who did a history of vaccination after starting their work. Anti-measles IgG and anti-mumps IgG was detected using chemiluminescence immunoassay. Anti-rubella IgG was detected using chemiluninescence microparticle immunoassay. Equivocal value was treated as negative. We also compare the costs between strategies two-dose vaccination without antibody tests and vaccination after antibody testing.ResultsTotal 598 HCWs were included in analysis. Of the HCWs tests, 92.6% were seropositive to measles, 86.6% to mumps, and 79.7% to rubella. In the linear regression analysis, the seropositive of measles and rubella antibodies was increased in proportion to age (β-coefficient 43.4, 95% CI 35.1–51.6, P < 0.001 and β-coefficient 10.2, 95% CI 7.2–13.2, respectively). But, the seropositive to mumps was not related to age (β-coefficient 2.6, 95% CI -5.4–10.7, P = 0.52). The HCWs who has seropositive to all MMR was 67.2%. It was highest in 1970th birthyear (77.1%) and lowest in 1980th birthyear (60.6%). It costs less 18,000 wons ($15.5) per HCWs in strategy of vaccination after antibody testing than two-dose vaccination without antibody testing.ConclusionOur data warrant the needs for routine antibody test for MMR, followed by MMR vaccination in Korean HCWS. We expect that this strategy can save costs and avoid unnecessary vaccination.Disclosures All authors: No reported disclosures.

Factors Underlying Unmet Medical Needs: A Cross-Sectional Study.

Unmet medical needs refer to the state where a patient’s medical care or service is insufficient, inadequate, or lacking. Numerous factors influence unmet medical needs. We used a multi-pronged approach to explore the factors influencing unmet medical needs in the Korean health care system according to Anderson’s Behavioral Model of Health Services Use. To this end, we used data from 11,378 adults over 19 years old in the 2016 Korea Health Panel Survey and performed multiple logistic regression analyses. The odds of experiencing unmet medical needs were significantly greater among older participants (odds ratio (OR) = 2.51, 95% confidence interval (CI) = 1.78–3.56); low-income participants (OR = 1.41, 95% CI = 1.14–1.75); non-workers (OR = 1.24, 95% CI = 1.06–1.46); those who had received non-covered treatment (OR = 1.24, 95% CI = 1.08–1.42); those who did not regularly exercise (OR = 1.23, 95% CI = 1.02–1.48); and those experiencing pain (OR = 2.29, 95% CI = 1.97–2.66), worse self-rated health status (OR = 2.29, 95% CI = 1.89–2.79), and severe depression (OR = 2.46, 95% CI = 1.39–4.35). About one in ten Korean citizens (11.60%) have unmet medical service needs. Policies that strengthen coverage for physically and economically vulnerable groups are needed.

Changes in medical research trends of North Korea after economic sanctions: A PRISMA-compliant systematic literature review of North Korean medical journals.

Background:In the 1980s, North Korea established a socialist health care system. However, following the food crisis and the economic sanctions, it is estimated that North Korea's health care system has experienced continuous deterioration. Thus, in the present study, we estimated the current medical research trends of North Korea through an analysis of the medical journal Korean Medicine, published in North Korea.Methods:We analyzed the studies in Korean Medicine, which is the only North Korean medical journal accessible to foreigners with more than 30 years of data available, based on PRISMA guidelines. We analyzed the issues of the journal published for a total of 7 years, from 1985 onwards at 5-year intervals until 2015. To evaluate changes in the North Korean medical research trends, we compared and analyzed the issues published before and after the implementation of economic sanctions against North Korea.Results:In this study, we analyzed 775 articles of Korean Medicine. Following economic sanctions, the number of publications on approved services (conventional therapy and diagnosis)-related articles was decreased. In contrast, the articles related to non-conventional therapy increased sharply in number. This showed a similar pattern to North Korean medical research trends seen during the food crisis of 1995 to 1997.Conclusions:After placement of economic sanctions on North Korea, North Korean medical research trends changed significantly. These could be indirectly estimated results suggesting that recently, the North Korean health care system had deteriorated, similarly to in the food crisis of 1995 to 1997.

The Socialist Camp's North Korean Medical Support and Exchange (1945-1958): Between Learning from the Soviet Union and Independent Course.

This study focused on the socialist camp's North Korean medical support and its effects on North Korean medical field from liberation to 1958. Except for the Soviet assistance from liberation to the Korean War, existing studies mainly have paid attention to the 'autonomous' growth of the North Korean medical field. The studies on the medical support of the Eastern European countries during the Korean War have only focused on one-sided support and neglected the interactions with the North Korean medical field. Failing in utilizing the materials produced in North Korea has led to the omission of detailed circumstances of providing support. Since the review of China's support and the North Korea-China medical exchanges has been concentrated in the period after the mid-1950s, the impacts of China's medical support on North Korea during the Korean War period and the post-war recovery period have not been taken into account. In terms of these limitations, this study examined the medical activities by the Socialist camp of the Eastern European countries in North Korea after the Korean War. The medical aid teams from Hungary, Romania, Bulgaria, Czechoslovakia, Poland, and East Germany that came to North Korea in the wake of the Korean War continued to stay in North Korea after the war to build hospitals and train medical personnel. In the hospitals operated by these countries, cooperative medical care with North Korean medical personnel and medical technology education were conducted. Moreover, medical teams from each country in North Korea held seminars and conferences and exchanged knowledge with the North Korean medical field staffs. These activities by the Socialist countries in North Korea provided the North Korean medical personnel with the opportunity to directly experience the medical technology of each country. China's support was crucial to North Korea's 'rediscovery' of Korean medicine in the mid-1950s. After the Korean War, North Korea began to apply the Chinese-Western medicine integration policy, which was performed in China at that time, to the North Korean health care field through China's medical support and exchanges. In other words, China's emphasis on Chinese medicine and the integration of the Chinese-Western medicine were presented as one of the directions for medical development of North Korea in the 1950s, and the experiences of China in this process convinced North Korea that Korean medicine policy was appropriate. The decision-makers of the North Korean medical policies, who returned to North Korea after studying abroad in China at that time, actively introduced the experiences from China and constantly sought to learn about them. This study identified that a variety of external stimuli had complex impacts on the North Korean medical field in the gap between 'Soviet learning' in the late 1940s and the 'autonomous' medical development since the 1960s. The North Korean medical field was formed not by the unilateral or dominant influences of a single nation but by the stimulation from many nations and the various interactions in the process.

Development of an Anticholinergic Burden Scale specific for Korean older adults.

The aim of this study was to develop the Korean Anticholinergic Burden Scale through assessment of previously developed tools, a literature review and a modified Delphi process. We carried out a systematic review to identify previously published anticholinergic burden tools. A composite medication list was made by extracting medications and their quantitative grading from the existing tools, after excluding the medications not distributed in Korea and topical agents. We also added medications available in Korea that had not been rated. For medications with conflicting anticholinergic scores or no anticholinergic score, we determined the final score from 0 ("no anticholinergic effect") to 3 ("strong anticholinergic effect") with a literature review and expert consensus through a two-round Delphi process. A composite list of 655 medications with anticholinergic scores was extracted from 10 existing tools. A total of 38 medications available in Korea were added to the list. A total of 494 medications were deemed suitable for a Korean-specific scale. We confirmed the anticholinergic scores of 352 medications from existing scales, and 142 underwent the Delphi process. The final scores graded by experts showed high reliability among experts with an intra-class correlation of 0.98 (95% confidence interval 0.97-0.98). Finally, 56 medications were categorized as strong anticholinergics, 23 as moderate, 59 as weak and 356 as having no anticholinergic activity. This newly created consensus-driven anticholinergic burden scale designed specifically for the Korean healthcare system might be a practical tool for assessing anticholinergic burden in older adults with polypharmacy in routine medication reviews and in research. Geriatr Gerontol Int 2019; 19: 628-634.

Perceived cultural differences in healthcare for foreign patients visiting South Korea: tool development and measurement

BackgroundWe developed a 41-item tool measuring cultural differences in healthcare as perceived by foreign patients visiting South Korea.MethodsThe tool was tested on 256 foreign patients who visited three tertiary hospitals in Seoul, South Korea. Content validity was explored by two physicians and eight nurses working in an international healthcare department. Structural validity was tested via exploratory factor analysis and by testing two hypotheses: (1) there are perceived cultural differences between the South Korean healthcare and those of foreign patients’ home countries (one-sample t-test); and, (2) Perceived cultural differences vary among language groups (analysis of variance). We also calculated Cronbach’s alpha.ResultsThe content validity index of the tool was 0.97. Exploratory factor analysis identified seven significant factors: hospital care and services, food, the healthcare system, communication, the healthcare facility, religion, and cultural values. The overall Cronbach’s alpha for the tool was 0.96, indicating very high internal consistency. We found that foreign patients visiting South Korean hospitals perceived that the healthcare culture differed significantly from that of their home country. The perceived cultural differences varied significantly by language group.ConclusionsNurses can use our new tool to understand the cultural differences of foreign patients and provide them with culturally competent nursing care.

Overview of Migrant Women’s Health in South Korea: Policy Recommendations

Every year, the Republic of Korea (Korea) welcomes new immigrants, thereby transitioning from a homogenous society to a multicultural country. Of these immigrants, migrant workers represent the largest group, followed by women who immigrate as spouses to Korean men. One great concern of Korea’s policymakers and healthcare providers is how Korea’s healthcare system can handle the deterioration of health observed among married Asian female immigrants. The health care system, mediated by the competitive relationship between local clinics and hospitals exacerbate the problem. The authors present possible solutions to the problems through a conceptual model of the relationship between socioeconomic status (SES), Korean healthcare system, food insecurity (FI), and health status. Different policies are proposed including: before you/she come (s) policy, foreign women workforce participation policy, poverty alleviation policy, health insurance policy for migrant women, health professional training policy, food insecurity policy and dietary acculturation policy. More government owned hospitals or private clinics should be built in rural areas. Married migrant women with good income seem to enjoy better health. Developing rural areas though economic empowerment will certainly create job opportunities.

Ethical Consideration of National Health Insurance Reform for Universal Health Coverage in the Republic of Korea.

In the current era of the Sustainable Development Goals (SDGs), many countries are attempting to strengthen their health system and achieving Universal Health Coverage (UHC). The Korean National Health Insurance (NHI) system functions as a core element of health financing, contributing to achieving UHC by promoting public health and social security through insurance benefits for prevention, diagnosis, treatment, rehabilitation, childbirth, and health promotion. The Republic of Korea achieved 100% NHI coverage of the target population in 1989, 12years after the introduction of the social insurance system. However, poor coverage of health services and lack of financial protection are major obstacles to achieving UHC. Therefore, the Korean government announced and implemented 'Moon Jae-in Care' in August 2017 to enhance the coverage rate of NHI by 70%. First, this study reviews the existing health insurance system in Korea from the perspective of health financing and UHC. Second, it analyses 'Moon Jae-in Care', based on the main framework of UHC. Third, it considers the ethical implications of these developments, with focus on the principles of equity, fairness, autonomy, and solidarity. Although the NHI reform is expected to propel Korean health care closer to UHC, many ethical, social, and political issues remain.

Cost-Utility of a Two-Dose Human Papillomavirus Vaccination Programme Added to Cervical Cancer Screening Compared with Cervical Cancer Screening Alone in Korea

Background:Cervical cancer is caused by the human papillomavirus and is a leading cause of cancer death among young Korean women. Current screening programmes could benefit from the addition of HPV vaccination into their schedule to help reduce disease burden. Two-dose vaccination schedules targeting HPV types 16 and 18, which are responsible for most cervical cancer cases, have recently been approved. Of the two available vaccines, AS04-adjuvanted HPV16/18 vaccine (AS04-HPV16/18v) provides greater protection against non-vaccine oncogenic HPV, while HPV-6/11/16/18 vaccine (4vHPVv) provides protection against genital warts. Methods:The health and economic consequences of introducing a two-dose HPV vaccination programme in 12-year-old girls together with screening were assessed in the Korean healthcare setting using a previously-published Markov model. Results:Compared with screening alone, AS04-HPV16/18v was cost-effective (incremental cost-effectiveness ratio below and within the Korean Won [KRW] 20-30 million treshold). When comparing the two vaccines, at 3% discount rate, AS04-HPV16/18v dominated 4vHPVv (i.e., provided 174 more quality-adjusted life-years (QALYs), 304 more life-years (LYs) and cost-savings of KRW 980 million). At a 5% discount rate, AS04-HPV16/18v provided comparable QALYs (albeit 5 fewer), 105 more LYs and cost-savings of KRW 292 million compared with 4vHPVv. Results were particularly sensitive to the discount rate used, as the health benefits of preventing cervical cancer are observed much later than those of preventing genital warts. Conclusion:For the Korean setting, HPV vaccination with a two-dose schedule is a cost-effective option, and AS04-HPV16/18v is likely to offer better health outcomes at a cost-saving compared with 4vHPVv.

A History of Korean Healthcare Design Research -Chronological Analysis of Research Trends-

A History of Korean Healthcare Design Research -Chronological Analysis of Research Trends-

Impression of South Korea and Korean Health Care from a Visitor

Impression of South Korea and Korean Health Care from a Visitor

개방형 혁신 기반 의료기기 아이디어 실현화 플랫폼의 위험관리

Recently the korean healthcare industry has been growing rapidly due to ageing population and its ever-growing concern about well-being. The global competitiveness of korean medical device industry is however relatively mediocre compared to that of other domestic industries. To remedy such an undesirable situation, the korean government has supported, since 2010, the project of establishing intermediator platforms which collect viable ideas from the medical care providers, develop working mock-ups or prototypes from these ideas and license these technologies out to the manufacturers who want to commercialize them. The purpose of this study is to analyze the risks which can cause the failure of such an open-innovation-based idea realization platform and derive some useful guidelines for their effective management. More precisely, we analyze the objectives of the platform, identify typical sources of failure that make the fulfillment of these objectives difficult, and select and evaluate major risk factors which contribute to each failure source. The analysis is based on the results of the structured interview with the supervising director of the idea realization center, the one first started in 2010, and the results of the questionnaire survey conducted on the experts who participated in several parts of the idea realization process in that organization. The results show that ‘a weak network among idea sources’ and ‘an inappropriate compensation system for realized ideas’ are the most important risk factors, together with ‘an insufficient development capacity’ and ‘the risk of failure to find interested buyers for the secured technology rights’. Thorough understanding of those risk factors and appropriate decisions on the response measures, and their continuous monitoring, would be essential part of risk management for an open-innovation-based medical device idea realization platform.

Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study.

BackgroundThe prevalence of diabetes mellitus (DM) continues to increase, and the disease burden is the highest of any medical condition in Korea. However, large-scale clinical studies have not yet conducted to establish the basis for diabetes prevention in Korea.MethodsThe hospital-based Korean Diabetes Prevention Study (H-KDPS) is a prospective, multi-center, randomized, open-label controlled study conducted at university hospitals for the purpose of gathering data to help in efforts to prevent type 2 DM. Ten university hospitals are participating, and 744 subjects will be recruited. The subjects are randomly assigned to the standard care group, lifestyle modification group, or metformin group, and their clinical course will be observed for 36 months.ResultsAll intervention methodologies were developed, validated, and approved by Korean Diabetes Association (KDA) multi-disciplinary team members. The standard control group will engage in individual education based on the current KDA guidelines, and the lifestyle modification group will participate in a professionally guided healthcare intervention aiming for ≥5% weight loss. The metformin group will begin dosing at 250 mg/day, increasing to a maximum of 1,000 mg/day. The primary endpoint of this study is the cumulative incidence of DM during the 3 years after randomization.ConclusionThe H-KDPS study is the first large-scale clinical study to establish evidence-based interventions for the prevention of type 2 DM in Koreans. The evidence gathered by this study will be useful for enhancing the health of Koreans and improving the stability of the Korean healthcare system (Trial registration: CRIS KCT0002260, NCT02981121).