Cross-cultural adaptation of the Korean Synkinesis Assessment Questionnaire: A validation study.

Objective: The Synkinesis Assessment Questionnaire (SAQ) is a reliable tool to assess synkinesis symptoms; however, it is yet to be validated in Korea. Thus, this study aimed to translate and validate the Korean SAQ. Methods: This validation study was set in a clinic in Seoul, Korea, that provides general integrative medicine services. A total of 100 participants with facial palsy were enrolled. Participants completed the SAQ, House-Brackmann grade (HB grade), Sunnybrook Facial Grading System (SB), and Facial Disability Index (FDI). The forward-backward translation method was followed. Of the 100 participants, 31 underwent a second assessment for test-retest reliability. Internal consistency and test-retest reliability were evaluated using Cronbach's alpha coefficient. The construct validity of the Korean version of the SAQ was tested using Spearman's rank correlation coefficient. Results: The internal consistency score for the SAQ was 0.789, and the test-retest reliability score was 0.787. According to Spearman's rank correlation coefficient, the SAQ correlations to the synkinesis subdomain of SB score, total SB score, HB grade, and physical function domain in the FDI score were 0.366 (p < .001), -0.386 (p < .001), 0.315 (p = .001), and -0.269 (p = .007), respectively. All values were statistically significant. Conclusions: The Korean SAQ is a valid and reliable tool used to evaluate synkinesis in patients with facial palsy. Level of Evidence: Level 3.

Korean Guidelines for Pharmacoeconomic Evaluations: Updates in the Third Version.

The first version of the pharmacoeconomic (PE) guidelines was published in South Korea in 2006. Despite its first revision in 2011, there were still ambiguities in its interpretation. Moreover, methodologies for estimating effectiveness and costs have also evolved since then. Under these circumstances, the Health Insurance Review and Assessment Service published the third version in January 2021. This article reviews the revision process and major changes made in the new edition of the PE guidelines. The revision was processed through reviews of the previous 50 PE submissions, international guidelines, academic literature, and surveys and advisory meetings to obtain stakeholders' opinions. The analysis perspective has changed from a limited societal perspective to a healthcare system perspective. In addition to the drug with the highest market share, drugs used in clinical trials can be selected as comparators under certain conditions. The discount rate decreased from 5% to 4.5%. Furthermore, the revised guidelines provide more detailed and specific instructions for items including non-inferiority margin, extrapolation, utility elicitation, and uncertainty. Treatment switch and co-dependent technology guidelines are newly included; the budget impact analysis guideline is deleted. Through this revision, transparency and consistency of decision-making is expected to improve.

Role of economic evidence in coverage decision-making in South Korea.

OBJECTIVES: The South Korean government required the submission of economic evidence when it implemented the Positive-List System in December 2006. This study investigates the key factors that influenced actual public insurance reimbursement decisions, including the role of economic evidence, after 10 years of decision practice under compulsory health technology assessment (HTA) for new drugs. METHOD: Logistic regression analysis was used to estimate the impact of the variables involved, including cost-effectiveness ratio as a key variable, on reimbursement decisions. The latter were defined as "yes" or "no" at a submitted price and indication. Only cases (n = 91) that present a cost-effectiveness ratio, and that have been reviewed based on this ratio from January 2007 to December 2016, were included in the analysis. RESULTS: Cases with higher cost-effectiveness ratios were less likely to be accepted. In addition, drugs that were used to treat severe diseases and drugs with no substitute were more likely to be recommended. The probability of acceptance declined along with the level of uncertainty in the submitted evidence. The acceptance rate for severe-disease drugs has increased since 2013, when the government introduced several policies that lowered the existing barriers to positive reimbursement. However, such an increase was not statistically significant. CONCLUSIONS: Cost-effectiveness is one of the most influential factors in drug-reimbursement decisions. However, inclusion of other explanatory variables, in addition to the cost-effectiveness ratio, predicted the results of decisions more accurately.

Safety assessment of mainstream smoke of herbal cigarette.

Owing to the increase in price of cigarettes in Korea, herbal cigarettes have received increasing attention as a non-smoking aid; however, its safety has hardly been studied. We analyzed some of the toxic components in the mainstream smoke of herbal cigarettes, performed a mutagenicity test on smoke condensates for safety assessment, and compared the results with the corresponding values of a general cigarette with the same tar content. Herbal cigarette "A" was smoked using automatic smoking machine under ISO conditions in a manner similar to general cigarette "T". The tar content measured was higher than that inscribed on the outside of a package. The mainstream smoke of herbal cigarette "A" did not contain detectable levels of tobacco-specific nitrosamines and nicotine. Carbon monoxide and benzo(α)pyrene contents in herbal cigarette "A" were higher than those in the general cigarette "T". The phenolic contents such as hydroquinone, resorcinol, and catechol in herbal cigarette "A" were higher than those in the general cigarette "T", but cresol contents in herbal cigarette "A" were lower than those in the general cigarette "T". The content of aromatic amines such as 4-aminobiphenyl in herbal cigarette "A" was higher than that in the general cigarette "T"; however, this difference was not statistically significant. On the other hand, 1-aminonaphthalene, 2-aminonaphthalene, and 3-aminobiphenyl contents in herbal cigarette "A" were lower than those in the general cigarette "T". The smoke condensates of herbal cigarette "A" exhibited a higher mutagenic potential than the condensates from the general cigarette "T" at the same concentration. We concluded that the mainstream smoke of herbal cigarette contains some toxic components, the smoke condensates of herbal cigarettes are mutagenic similar to general cigarette because of combustion products, and that the evaluation of the chemical and biological safety of all types of herbal cigarettes available on the market.

Evaluation on the first 2 years of the positive list system in South Korea.

OBJECTIVE: The South Korean positive list system in pharmaceutical reimbursement was introduced by the Health Care System Reform Act implemented in December 2006. This study introduces this positive list system (PLS), and reports on an evaluation of two years of operation. In addition, decision-making factors are evaluated and current issues and solutions discussed. METHODS: We analyzed 91 submissions with reimbursement decisions completed by December 31, 2008. Submission characteristics and relevant factors related to decision criteria were identified by the decision outcomes (recommended/rejected). RESULTS: Under the new system, Health Insurance Review and Assessment service (HIRA) recommended 64 submissions for reimbursement and rejected 27 submissions. For recommended submissions, 59 met all criteria and 5 were recommended based on the rule of rescue. The primary reason for rejection was unacceptable cost-effectiveness. The likelihood of recommendation was found to be significantly elevated if a drug was superior to its comparator, if treatment cost was not greater than that of its comparator, or if the number of recommended decisions made by other committees increased. CONCLUSIONS: The South Korean PLS has stabilized during the 2 years after its introduction. The recommended submissions were qualified in all decision-making criteria used. Among the various decision criteria, clinical benefit and cost-effectiveness were the main drivers of reimbursement decisions. In addition, there is a certain degree of consistency between the reimbursement decisions of HIRA and other countries.

Suicide risk in relation to social class: a national register-based study of adult suicides in Korea, 1999-2001.

BACKGROUND: Few controlled studies have examined social class as a risk factor for suicide in Korea. AIM: The objective of the present study was to investigate the effects of social class on suicide risk in Korea. METHODS: A case-control design was constructed from cause-of-death statistics for the period 1999 to 2001, in Korea, as published by the Korean National Statistical Office. The cases were defined as people aged between 20 and 64 who died by suicide, while the controls were defined as those who died of natural causes in the same age groups. RESULTS AND CONCLUSIONS: The proportions and odds ratios for suicide were higher in young people than in elderly people, and higher for divorced subjects than for cohabitants. They were also higher for residents of rural areas, as opposed to residents of Seoul and other metropolitan areas, and for people in social classes III and IV, than they were for those in social class I. To control the variables that influence risk of suicide, such as age, marital status and area of residence, we used multiple logistic regression. Compared with class I, risk of suicide was higher in social classes III and IV, in both sexes. The principal conclusion of this study is that, regardless of sex, lower social class constitutes a high risk for suicide in Korea, even after controlling for variables such as age, marital status and area of residence. We conclude that a well-controlled and balanced social welfare system could reduce suicide risk, especially among people in lower social class.