Background: and Purpose: The Cognitive Impairment Screening Test (CIST) was developed for use at the Community Dementia Reassurance Center in South Korea. This study evaluated convergent and discriminant validity of CIST, as well as its clinical utility in identifying cognitive impairment and differentiating amyloid deposition. Methods: We enrolled 252 participants from a hospital memory clinic (47 cognitively unimpaired [CU], 116 amnestic mild cognitive impairment, and 89 dementia). Participants completed CIST, K-MMSE-2, the Seoul Neuropsychological Screening Battery, 2nd edition (SNSB-II), and underwent amyloid positron emission tomography. To evaluate the convergent and discriminant validity of CIST, we conducted correlation analyses with SNSBII. Receiver operating characteristic analyses were used to evaluate the ability to discriminate cognitive impairment and to distinguish amyloid positivity. Areas under the curve (AUCs) for CIST and K-MMSE-2 were compared using DeLong’s test. Results: The total score of CIST correlated significantly with all SNSB-II subtests, and the domain scores of CIST showed stronger associations with corresponding SNSB-II subtests than with unrelated ones. Both CIST and K-MMSE-2 effectively distinguished cognitively impaired individuals from CU, with CIST demonstrating superior discrimination (AUC=0.926 vs.0.887, p=0.042). In the non-demented group, both CIST and K-MMSE-2 showed acceptable discrimination for amyloid positivity (AUC≈0.73), with high specificity but low sensitivity;however, there were no significant differences between the two tests. Conclusions The CIST demonstrated strong validity and discriminatory ability for detecting cognitive impairment. It also showed acceptable discrimination for amyloid positivity in non-demented participants, supporting its utility as a screening tool in both clinical and community settings.

Purpose: Following the withdrawal of propacetamol in Europe owing to safety issues, the regulatory authority of South Korea requested a post-marketing surveillance study to investigate its safety profile. Materials and Methods: We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens–Johnson syndrome (SJS), using the claims database of South Korea, 2010–2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol. Results: We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71–3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09–3.47). Conclusion In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.

Objective: Fall from height (FFH) is a major public health problem that can result in severe injury, disability, and death. This study investigated how the characteristics of jumpers and fallers differ. Methods: This was a retrospective study of FFH patients enrolled in an Emergency Department-based Injury In-depth Surveillance (EDIIS) registry between 2011 and 2018. Depending on whether the injury was intentional, FFH patients who had fallen from a height of at least 1 m were divided into two groups: jumpers and fallers. Patient characteristics, organ damage, and death were compared between the two groups, and factors that significantly affected death were identified using multivariable logistic analysis. Results: Among 39,419 patients, 1,982 (5.0%) were jumpers. Of the jumpers, 977 (49.3%) were male, while 30,643 (81.9%) of fallers were male. The jumper group had the highest number of individuals in their 20s, with the number decreasing as age increased. In contrast, the number of individuals in the faller group rose until reaching their 50s, after which it declined. More thoracoabdominal, spinal, and brain injuries were found in jumpers. The in-hospital mortality of jumpers and fallers was 832 (42.0%) and 1,268 (3.4%), respectively. Intentionality was a predictor of in-hospital mortality, along with sex, age, and fall height, with an odds ratio of 7.895 (95% confidence interval, 6.746–9.240). Conclusion Jumpers and fallers have different epidemiological characteristics, and jumpers experienced a higher degree of injury and mortality than fallers. Differentiated prevention and treatment strategies are needed for jumpers and fallers to reduce mortality in FFH patients.

Purpose: Cancer antigen 15-3 (CA15-3) is a serum tumor marker for breast cancer (BC) extensively used in clinical practice. CA15-3 is non-invasive, easily available, and a costeffective tumor marker for immediate diagnosis, monitoring and prediction of BC recurrence. We hypothesized that an elevation of CA15-3 may have prognostic impact in patients with early BC with normal serum CA15-3 level. Methods: This was a retrospective cohort study, which included patients with BC who received curative surgery at a comprehensive single institution between 2000 and 2016.CA15-3 levels from 0 to 30 U/mL were considered normal, and patients who had CA15-3 > 30 U/mL, were excluded from the study. Results: The mean age of study participants (n = 11,452) was 49.3 years. The proportion of participants with elevated CA15-3 ≥ 1 standard deviation (SD) compared with the previous examination during follow-up was 23.3% (n = 2,666). During the follow-up (median followup 5.8 years), 790 patients experienced recurrence. The fully-adjusted hazard ratio (HR) for recurrence comparing participants with stable CA15-3 level to subjects with elevated CA15-3 level was 1.76 (95% confidence interval [CI], 1.52–2.03). In addition, if the CA15-3was elevated ≥ 1 SD, the risk was much higher (HR, 6.87; 95% CI, 5.81–8.11) than in patients without elevated CA15-3 ≥ 1 SD. In sensitivity analysis, the recurrence risk was consistently higher in participants with elevated CA15-3 levels than in participants without elevated CA15-3 levels. The association between elevated CA15-3 levels and incidence of recurrence was observed in all subtypes and the association was stronger in patients with N+ than in patients with N0 stage (p-value for interaction < 0.01). Conclusion The results of the present study demonstrated that elevation of CA15-3 in patients with early BC and initial normal serum CA15-3 levels has a prognostic impact.

Background: High LDL-cholesterol (LDL-C) is an established risk factor for cardiovascular disease and is considered an important therapeutic target. It can be measured directly or calculated from the results of other lipid tests. The Friedewald formula is the most widely used formula for calculating LDL-C. We modified the Friedewald formula for a more accurate and practical estimation of LDL-C. Methods: Datasets, including measured triglyceride, total cholesterol, HDL-cholesterol, and LDL-C concentrations were collected and assigned to derivation and validation sets. The datasets were further divided into five groups based on triglyceride concentrations. In the modified formula, LDL-C was defined as total cholesterol − HDL-cholesterol − (triglyceride/adjustment factor). For each group, the adjustment factor that minimized the difference between measured LDL-C and calculated LDL-C using modified formula was obtained. For validation, measured LDL-C and LDL-C calculated using the modified formula (LDL-CM), Friedewald formula (LDL-CF), Martin-Hopkins formula (LDL-CMa), and Sampson formula (LDL-CS) were compared. Results: In the derivation set, the adjustment factors were 4.7, 5.9, 6.3, and 6.4 for the groups with triglyceride concentrations <100, 101–200, 201–300, and >300 mg/dL, respectively. In the validation set, the coefficient of determination (R2) between measured and calculated LDL-C was higher for LDL-CM than for LDL-CF (R2=0.9330 vs. 0.9206). The agreement according to the National Cholesterol Education Program Adult Treatment Panel III classification of LDL-C was 86.36%, 86.08%, 86.82%, and 86.15% for LDL-CM, LDL-CF, LDL-CMa, and LDL-CS, respectively. Conclusions We proposed a practical, improved LDL-C calculation formula by applying different factors depending on the triglyceride concentration.

Background/Aims: This study aimed to investigate the effect of hepatocellular carcinoma (HCC) surveillance using the Korea National Liver Cancer Screening Program on the receipt of curative treatment for HCC and mortality in patients with chronic liver disease. Methods: This population-based cohort study from the Korean National Health Insurance Service included 2003 to 2015 claims data collected from 1,209,825 patients aged ≥40 years with chronic hepatitis B, chronic hepatitis C, and liver cirrhosis. Patients were divided according to HCC surveillance using ultrasonography and serum alpha-fetoprotein every 6–12 months. The study outcomes were the receipt of curative treatment (surgical resection, radiofrequency ablation, or liver transplantation) and all-cause mortality. Results: The study population consisted of 1,209,825 patients with chronic hepatitis B, chronic hepatitis C, and liver cirrhosis (median age, 52.0 years; interquartile range, 46–55 years; 683,902 men [56.5%]). The proportion of participants who underwent HCC surveillance was 52.7% (n=657,889). During 10,522,940 person-years of follow-up, 74,433 HCC cases developed, including 36,006 patients who underwent curative treatment. The surveillance group had a significantly higher proportion of curative treatment for HCC than the non-surveillance group after adjusting for confounding factors (adjusted hazard ratio [HR], 5.64; 95% confidence interval [CI], 5.48–5.81). The surveillance group had a significantly lower mortality rate than the non-surveillance group (adjusted HR, 0.56; 95% CI, 0.55–0.56). Conclusions HCC surveillance using the national screening program in patients with chronic viral hepatitis or liver cirrhosis provides better opportunity for curative treatment for HCC and improves overall survival.

Gastric cancer (GC) is the fourth most common cause of cancer-related death globally. The classification of advanced GC (AGC) according to molecular features has recently led to effective personalized cancer therapy for some patients. Specifically, AGC patients whose tumor cells express high levels of human epidermal growth factor receptor 2 (HER2) can now benefit from trastuzumab, a humanized monoclonal Ab that targets HER2. However, patients with HER2negative AGC receive limited clinical benefit from this treatment. To identify potential immune therapeutic targets in HER2negative AGC, we obtained 40 fresh AGC specimens immediately after surgical resections and subjected the CD45 + immune cells in the tumor microenvironment to multi-channel/multi-panel flow cytometry analysis. Here, we report that HER2 negativity associated with reduced overall survival (OS) and greater tumor infiltration with neutrophils and non-classical monocytes. The potential pro-tumoral activities of these cell types were confirmed by the fact that high expression of neutrophil or non-classical monocyte signature genes in the gastrointestinal tumors in The Cancer Genome Atlas, Genotype-Tissue Expression and Gene Expression Omnibus databases associated with worse OS on Kaplan-Meir plots relative to tumors with low expression of these signature genes. Moreover, advanced stage disease in the AGCs of our patients associated with greater tumor frequencies of neutrophils and non-classical monocytes than early stage disease. Thus, our study suggests that these 2 myeloid populations may serve as novel therapeutic targets for HER2negative AGC.

Purpose: Treatment with 4 cycles of docetaxel and cyclophosphamide (TC) in the adjuvant setting is associated with better outcomes than treatment with doxorubicin and cyclophosphamide (AC). However, Western guidelines have indicated that TC confers a high risk (>20%) of febrile neutropenia (FN), while AC confers an intermediate risk (10%–20%) of FN. Threrefore, we evaluated the incidence of FN and the clinical utilization of pegfilgrastim prophylaxis after adjuvant TC chemotherapy. Methods: We categorized 201 patients who received adjuvant TC chemotherapy into 3 groups according to the method of prophylaxis and compared neutropenic events, other adverse events, and hospital care costs in the 3 groups. Results: The incidence of grade 4 neutropenia decreased from 93.0% in patients without prophylaxis to 82.4% in those who received secondary prophylaxis and 16.7% in those who received primary prophylaxis. Although the incidence of FN was not different between patients without prophylaxis and patients who received secondary prophylaxis (15.7% and 14.9%), none of the patients who received primary prophylaxis developed FN. Moreover, a decrease in neutropenic events resulted in a significant decrease in the mean duration of neutropenia (2.50 days to 0.08 days, P < 0.001), the risk of hospitalization (29.8% to 2.2%, P < 0.001), and the mean total hospital care cost for all chemotherapy cycles (790.80 to 486.00 US dollars, P < 0.001). Conclusion The use of pegfilgrastim prophylaxis during adjuvant TC chemotherapy is associated with significant decreases in the incidence of neutropenic events, hospitalization, and hospital care cost compared to those seen in patients without prophylaxis.

BACKGROUND AND PURPOSE: Evaluating instrumental activities of daily living (IADL) is an important part of procedure to diagnose dementia. The Korean-Instrumental Activities of Daily Living (K-IADL) has been used extensively in Korea. However, its cut-off score has not been reformulated since 2002. The purpose of this study was to yield a new optimal cut-off score for the K-IADL and confirm the validity of this new cut-off score with various dementia groups. METHODS: We retrospectively collected a total of 2,347 patients' K-IADL data from 6 general hospitals in Korea. These patients had mild cognitive impairment (MCI) or dementia with various etiologies for cognitive impairment. We also recruited a normal control group (n=254) from the community. Korean-Mini Mental State Examination, Short version of the Geriatric Depression Scale, Clinical Dementia Rating, and Global Deterioration Scale were administered to all participants. Caregivers completed K-IADL and Barthel Index. RESULTS: K-IADL scores were significantly different among dementia subgroups, but not significantly different among MCI subgroups. Based on internal consistency, correlations with other scales, and factor analysis, K-IADL showed excellent reliability and validity. The new optimal cut-off score to diagnose dementia was 0.40, which gave a sensitivity of 0.901 and a specificity of 0.916. Positive predictive value for dementia using the new cut-off score was 94.2% for Alzheimer's disease, 100% for vascular dementia, and 84% for Parkinson's disease. CONCLUSIONS: Our results illustrate that the new K-IADL cut-off score of 0.40 is reliable and valid for screening impairments of daily functioning resulting from various etiologies.
Activities of Daily Living* ; Alzheimer Disease ; Caregivers ; Cognition Disorders ; Dementia ; Dementia, Vascular ; Depression ; Hospitals, General ; Humans ; Korea ; Mass Screening ; Mild Cognitive Impairment ; Parkinson Disease ; Reproducibility of Results ; Retrospective Studies ; Sensitivity and Specificity ; Weights and Measures

BACKGROUND: Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA). METHODS: A fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs—Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)—using 20 seroconversion panels and 3,500 clinical serum samples. RESULTS: Evaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed. CONCLUSIONS: The AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.
Fluorescence ; Gangwon-do ; Genotype ; Hepacivirus ; Hepatitis B Surface Antigens* ; Hepatitis B virus ; Hepatitis B* ; Hepatitis C* ; Hepatitis* ; Immunoassay* ; Mass Screening ; Sensitivity and Specificity ; Seroconversion