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Europe, the United States (U.S), and Korea each maintain post-marketing surveillance (PMS) systems to monitor rare or unexpected adverse events. Korea's PMS mainly involves a re-examination system to identify new adverse events not seen in pre-market trials during the early stages of post-marketing drug use, along with the risk management plan (RMP), a comprehensive strategy using methods like signal detection to regularly assess safety and benefit-risk throughout the drug's lifecycle. This study compares the post-marketing safety issues associated with dapagliflozin as identified by the European Medicines Agency (EMA), the U.S Food and Drug Administration (FDA), and in Korea. To identify these safety issues, we reviewed the safety concerns listed in the European Union RMP (EU-RMP), adverse events noted in the Warnings and Precautions section of the U.S FDA drug label, and use-result surveillance results detailed in the Korean Ministry of Food and Drug Safety drug label. Additionally, we used Korean Adverse Event Reporting System (KAERS) data to detect safety signals. We manually matched and compared safety issues identified by the EMA and FDA with those recognized in Korea. For safety issues unique to Korea, we compared KAERS signals with the results from use-result surveillance. We compared 17 EMA/FDA safety issues with 38 KAERS signals and 231 results from use-result surveillance. While there was a significant concordance (71%) between the safety issues identified by the EMA/FDA and those in Korea, Korean safety issues had limitations in capturing long-term outcomes and laboratory results. Some safety issues that were initially recognized in the EU-RMP and FDA drug labels were no longer found in the latest documents. To enhance PMS in Korea, it is necessary to establish more specific laws and regulations and develop detailed guidelines that utilize a variety of real-world data and research methodologies to continuously assess causality throughout the product lifecycle., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Park et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The mortality rates of COVID-19 vary across the globe. While some risk factors for poor prognosis of the disease are known, regional differences are suspected. We reviewed the risk factors for critical outcomes of COVID-19 according to the location of the infected patients, from various literature databases from January 1 through June 8, 2020. Candidate variables to predict the outcome included patient demographics, underlying medical conditions, symptoms, and laboratory findings. The risk factors in the overall population included sex, age, and all inspected underlying medical conditions. Symptoms of dyspnea, anorexia, dizziness, fatigue, and certain laboratory findings were also indicators of the critical outcome. Underlying respiratory disease was associated higher risk of the critical outcome in studies from Asia and Europe, but not North America. Underlying hepatic disease was associated with a higher risk of the critical outcome from Europe, but not from Asia and North America. Symptoms of vomiting, anorexia, dizziness, and fatigue were significantly associated with the critical outcome in studies from Asia, but not from Europe and North America. Hemoglobin and platelet count affected patients differently in Asia compared to those in Europe and North America. Such regional discrepancies should be considered when treating patients with COVID-19.

Purpose: Optical coherence tomography (OCT) captures retinal damage in neuromyelitis optica spectrum disorders (NMOSD). Previous studies investigating OCT in NMOSD have been limited by the rareness and heterogeneity of the disease. The goal of this study was to establish an image repository platform, which will facilitate neuroimaging studies in NMOSD. Here we summarise the profile of the Collaborative OCT in NMOSD repository as the initial effort in establishing this platform. This repository should prove invaluable for studies using OCT to investigate NMOSD., Participants: The current cohort includes data from 539 patients with NMOSD and 114 healthy controls. These were collected at 22 participating centres from North and South America, Asia and Europe. The dataset consists of demographic details, diagnosis, antibody status, clinical disability, visual function, history of optic neuritis and other NMOSD defining attacks, and OCT source data from three different OCT devices., Findings to Date: The cohort informs similar demographic and clinical characteristics as those of previously published NMOSD cohorts. The image repository platform and centre network continue to be available for future prospective neuroimaging studies in NMOSD. For the conduct of the study, we have refined OCT image quality criteria and developed a cross-device intraretinal segmentation pipeline., Future Plans: We are pursuing several scientific projects based on the repository, such as analysing retinal layer thickness measurements, in this cohort in an attempt to identify differences between distinct disease phenotypes, demographics and ethnicities. The dataset will be available for further projects to interested, qualified parties, such as those using specialised image analysis or artificial intelligence applications., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The prognostic significance of molecular mutations (FLT3-ITD, NPM1, and CEBPA mutations) was examined in patients with normal-karyotype acute myeloid leukaemia (NK-AML) after allogeneic haematopoietic cell transplantation (HCT). In total, 115 patients received allogeneic HCT for NK-AML and were evaluated for FLT3-ITD, NPM1, and CEBPA mutations in diagnostic samples and for long-term outcomes following HCT, retrospectively. The prevalences of FLT3-ITD(pos), NPM1 (mut), and CEBPA (dm) (double mutations) were 32.2, 43.5, and 24.6 %, respectively. The triple-negative group (NPM1 (wild)/FLT3-ITD(neg)/non-CEBPA (dm)) showed a similar transplant outcome to those in the favourable European LeukemiaNet (ELN) risk group for overall survival (OS) (60.9 vs. 63.7 %; p = 0.810), but a more favourable OS than others in the intermediate-I risk group (40.0 %; p = 0.034). Also, the triple-negative group showed a similar relapse rate at 5 years compared with those in the favourable risk group (9.7 vs. 15.5 %; p = 0.499), but a lower rate of relapse than the others in the intermediate-I risk group (15.5 vs. 48.6 %; p = 0.004). The 5-year relapse incidences were 4.0 % (NPM1 (mut)/FLT3-ITD(neg)), 14.7 % (CEBPA (dm)), 15.5 % (NPM1 (wild)/FLT3-ITD(neg)/non-CEBPA (dm)), 39.1 % (NPM1 (mut)/FLT3-ITD(pos)/non-CEBPA (dm)), and 66.7 % (NPM1 (wild)/FLT3-ITD(pos)/non-CEBPA (dm)). Thus, the triple-negative (NPM1 (wild)/FLT3-ITD(neg)/non-CEBPA (dm)) group showed favourable long-term outcomes after allogeneic HCT in NK-AML, similar to those of the favourable risk group by the ELN risk classification.

Objective: We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer QLQ-PR25 when applied to Korean prostate cancer (PC) patients., Methods: A total of 172 patients who underwent curative radical prostatectomy (RP) with or without adjuvant androgen deprivation therapy were asked to complete the Korean version of the EORTC QLQ-C30 and PR25 questionnaires 3 times (before and 3 and 6 months after RP). Psychometric evaluation of the questionnaire was conducted., Results: Multitrait scaling analysis showed satisfactory construct validity in most scales except for bowel symptoms and hormonal treatment-related symptoms. Internal consistency tested by Cronbach's α coefficient met the 0.70 criterion for the urinary symptom, sexual activity and sexual functioning scales at the all 3 time points. Known-group comparison analyses showed better quality-of-life (QOL) scores in patients with higher performance status, and higher hormonal treatment-related symptom scores in patients on hormonal treatment. Responsiveness to changes was in line with clinical implications over time after RP., Conclusions: Our results show that the EORTC QLQ-PR25 questionnaire has adequate levels in cross-cultural validity. The Korean version of the EORTC QLQ-PR25 is a generally reliable and robust instrument for the assessment of various QOL aspects that can be self-administered to Korean PC patients undergoing RP., (© 2013 S. Karger AG, Basel.)

This study was conducted to examine the in vitro activity of antimicrobials against Campylobacter spp. isolates from chicken and human sources and the genetic interrelation among them. During 2004-2008, a total of 173 Campylobacter spp. isolated from chicken meats (60 domestic and 62 imported chicken meats) and humans (n = 51) were tested for susceptibility to nine antimicrobials. Of 173 isolates, 140 (80.9%) showed multidrug resistance (MDR) against three to eight antimicrobials. The most frequent pattern type was MDR to four antimicrobials: ciprofloxacin, nalidixic acid, ampicillin, and tetracycline. Over 52.6% (91/173) of the isolates tested were resistant to these four antibiotics simultaneously. Especially, two and five isolates originated from Korea and Brazil showed resistance against all antibiotics tested, except for florfenicol. Further, 95% (57/60) of the isolates originated from domestic chicken showed resistance to ciprofloxacin, the antimicrobial agent of choice for treatment of human campylobacteriosis. Genotypic characterization of all Campylobacter isolates performed by pulsed-field gel electrophoresis yielded 74 types among the 173 isolates. Isolates sharing the same or similar genetic clusters were detected in different countries at different times. The pulsed-field gel electrophoresis patterns of chicken-related isolates were closely related to those of isolates from humans with gastroenteritidis. The results of this study suggest that MDR Campylobacter spp. are widespread and that Campylobacter with similar genotypes are circulating both in humans and in chicken meat in Korea.

Context: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) is a shortened version of the EORTC QLQ-C30, developed for use in advanced cancer patients., Objectives: We evaluated the psychometric properties of the Korean version of the EORTC QLQ-C15-PAL to determine if this tool can be used to evaluate Korean patients with cancer who receive palliative care., Methods: A multicenter, cross-sectional survey was performed in palliative care units and hospices in Korea from September to October 2009. A total of 102 patients with cancer completed the questionnaires that included the EORTC QLQ-C15-PAL., Results: The compliance rate was high, with the missing rate for each item ranging from 0% to 7.8% (mean 3.1%). A multitrait scaling analysis revealed good convergent and discriminant validity, with only three scaling errors. The Cronbach's alpha coefficients ranged from 0.65 to 0.89. The questionnaire discriminated among patient subgroups with different clinical profiles (e.g., performance status and degree of oral intake), thereby demonstrating the clinical validity of this tool., Conclusion: Our findings indicate that the Korean version of the EORTC QLQ-C15-PAL is a reliable and valid instrument with regard to its psychometric properties. This tool is suitable for measuring quality of life, particularly with regard to physical aspects, in Korean cancer patients who receive palliative care., (Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

There are phenotypic differences between Korean native pig (KNP) and Yorkshire (YS) breeds due to different interests in selection. YS has been selected for industrial interests such as a growth rate and lean meat production, while KNP has been maintained as a regional breed with local interests such as disease resistance and fat content in and between muscle. A comparison of gene expression profiles from liver tissue reflected overall long-term effects of artificial selection for these two pig breeds. Based on minimum positive false discovery rate (less than 10%) and fold change (|FC|>1.5), 73 differentially expressed genes (DEGs) were identified. Functional analysis of these DEGs indicated clear distinctions in signaling capacity related to epidermal growth factor (EGF), extracellular structure, protein metabolism, and detoxification. Hepatic DEGs demonstrated the importance of hormonal and metabolic capabilities to differences between these two pig breeds.

The stereotype content model (SCM) proposes potentially universal principles of societal stereotypes and their relation to social structure. Here, the SCM reveals theoretically grounded, cross-cultural, cross-groups similarities and one difference across 10 non-US nations. Seven European (individualist) and three East Asian (collectivist) nations (N=1,028) support three hypothesized cross-cultural similarities: (a) perceived warmth and competence reliably differentiate societal group stereotypes; (b) many out-groups receive ambivalent stereotypes (high on one dimension; low on the other); and (c) high status groups stereotypically are competent, whereas competitive groups stereotypically lack warmth. Data uncover one consequential cross-cultural difference: (d) the more collectivist cultures do not locate reference groups (in-groups and societal prototype groups) in the most positive cluster (high-competence/high-warmth), unlike individualist cultures. This demonstrates out-group derogation without obvious reference-group favouritism. The SCM can serve as a pancultural tool for predicting group stereotypes from structural relations with other groups in society, and comparing across societies.

The authors argue that complementary hostile and benevolent components of sexism exist across cultures. Male dominance creates hostile sexism (HS), but men's dependence on women fosters benevolent sexism (BS)--subjectively positive attitudes that put women on a pedestal but reinforce their subordination. Research with 15,000 men and women in 19 nations showed that (a) HS and BS are coherent constructs that correlate positively across nations, but (b) HS predicts the ascription of negative and BS the ascription of positive traits to women, (c) relative to men, women are more likely to reject HS than BS, especially when overall levels of sexism in a culture are high, and (d) national averages on BS and HS predict gender inequality across nations. These results challenge prevailing notions of prejudice as an antipathy in that BS (an affectionate, patronizing ideology) reflects inequality and is a cross-culturally pervasive complement to HS.