Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols. Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention AgencyLaboratory Standardization Project (per CLSI C37-A), using six routine measurement procedures (MPs). Regression equations and 95% prediction intervals derived from single-donor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differences in inter-MP biases between RM and clinical samples. The effect of the TG concentration on commutability was evaluated by analyzing biases between MP results and reference procedure-assigned values. Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from assigned values were observed for RMs with higher TG levels. Conclusions RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to standardize laboratory tests.

Background: An international reference measurement laboratory network for creatinine (Cr) is lacking; therefore, Korea developed an independent evaluation and certification system. The in vitro diagnostics (IVD) certification program, launched in 2017, formed part of a broader Cr standardization initiative intended to enhance accuracy at the manufacturing stage. Methods: The program was designed to evaluate analytical systems, including all reagent lots, calibrators, and instrument models, twice annually. Bias, imprecision, total error (TE), and linearity were evaluated based on established acceptance criteria. A post-certification process allows submission for a second challenge and validation of corrective actions. Results: Between 2017 and 2023, 489 analytical systems were evaluated. Average acceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the kinetic Jaffe method without compensation in 2018. Over the 7-year period, the mean absolute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%,and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0 ≤ Cr < 1.0target value range. Since 2019, a consistent reduction in absBias% has been observed. Conclusions This program is a pioneering response to the absence of a global certification program for Cr assays. It offers significant advantages, including comprehensive evaluations, fee-free participation, and a robust post-certification process. Continuous participation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.

Objective: The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions. Methods: We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores. Results: The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks. Conclusion The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.

Objective: The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions. Methods: We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores. Results: The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks. Conclusion The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.

Objective: The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions. Methods: We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores. Results: The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks. Conclusion The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.

Background: s/Aims: Reported incidence of extrahepatic bile duct cancer is higher in Asians than in Western populations. Korea, in particular, is one of the countries with the highest incidence rates of extrahepatic bile duct cancer in the world. Although research and innovative therapeutic modalities for extrahepatic bile duct cancer are emerging, clinical guidelines are currently unavailable in Korea. The Korean Society of Hepato-Biliary-Pancreatic Surgery in collaboration with related societies (Korean Pancreatic and Biliary Surgery Society, Korean Society of Abdominal Radiology, Korean Society of Medical Oncology, Korean Society of Radiation Oncology, Korean Society of Pathologists, and Korean Society of Nuclear Medicine) decided to establish clinical guideline for extrahepatic bile duct cancer in June 2021. Methods: Contents of the guidelines were developed through subgroup meetings for each key question and a preliminary draft was finalized through a Clinical Guidelines Committee workshop. Results: In November 2021, the finalized draft was presented for public scrutiny during a formal hearing. Conclusions The extrahepatic guideline committee believed that this guideline could be helpful in the treatment of patients.

Objective: This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia. Methods: Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed. Results: Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea. Conclusion Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.

In the 2023 series, we summarized the major clinical research advances in gynecologic oncology based on communications at the conference of Asian Society of Gynecologic Oncology Review Course. The review consisted of 1) Endometrial cancer: immune checkpoint inhibitor, antibody drug conjugates (ADCs), selective inhibitor of nuclear export, CDK4/6 inhibitors WEE1 inhibitor, poly (ADP-ribose) polymerase (PARP) inhibitors. 2) Cervical cancer: surgery in low-risk early-stage cervical cancer, therapy for locally advanced stage and advanced, metastatic, or recurrent setting; and 3) Ovarian cancer: immunotherapy, triplet therapies using immune checkpoint inhibitors along with antiangiogenic agents and PARP inhibitors, and ADCs. In 2023, the field of endometrial cancer treatment witnessed a landmark year, marked by several practice-changing outcomes with immune checkpoint inhibitors and the reliable efficacy of PARP inhibitors and ADCs.

Objective: We aimed to revalidate the chemotherapy response score (CRS) system as a prognostic factor for ovarian cancer patients with breast cancer gene (BRCA) mutations or those receiving frontline poly-ADP ribose polymerase (PARP) inhibitors or bevacizumab as maintenance therapy. Methods: A retrospective analysis was performed using medical records of patients with high-grade serous carcinoma who received neoadjuvant chemotherapy followed by interval debulking surgery between January 2007 and December 2021 at 5 tertiary medical institutions in South Korea. At each hospital, pathologists independently assessed each slide of omental tissues obtained from surgery using the CRS system. Progression-free survival (PFS) and overall survival (OS) values were obtained using Kaplan-Meier analysis to evaluate the effect of BRCA mutation, maintenance therapy, and CRS on survival time. Results: Of 466 patients, BRCA mutations were detected in 156 (33.5%) and 131 (28.1%) were treated with maintenance therapy; 98 (21.0%) and 42 (9.0%) were treated with PARP inhibitors or bevacizumab, respectively. Patients with CRS3 had significantly longer PFS than those with CRS1 or 2 (24.7 vs. 16.8 months, p<0.001). However, there was no significant difference in PFS improvement between CRS3 patients and those with CRS1 or 2 with BRCA mutation (22.0 vs. 19.3 months, p=0.193). Moreover, no significant PFS prolongation was observed in CRS3 patients compared to CRS1 or 2 patients treated with PARP inhibitors or bevacizumab (24.3 vs. 22.4 months, p=0.851; 27.5 vs. 15.7 months, p=0.347, respectively). Conclusion CRS may not be a prognostic factor in patients with BRCA mutations and those receiving frontline maintenance therapy.

Purpose: We sought to evaluate the time-dependent efficacy and safety of eplerenone for central serous chorioretinopathy. Methods: A systematic search was performed from inception to May 2023 in the Medline, EMBASE, and Cochrane literature databases to find randomized controlled trials that have administered oral eplerenone therapy to central serous chorioretinopathy patients. Results: Five randomized controlled trials were included in the final analysis. Among a total of 252 central serous chorioretinopathy patients, 134 were included in the eplerenone group and 118 were included in the control group. The best-corrected visual acuity was statistically significantly improved in the eplerenone group compared to the control group (95% confidence interval [CI], -0.08 to -0.02; p = 0.001). After meta-analysis was performed at each follow-up point, it was found that eplerenone statistically significantly improved the best-corrected visual acuity compared to the control group at 2 and 3 months after starting oral eplerenone therapy, but there was no statistically significant difference at 6 months. Subretinal fluid, chorioretinal thickness, central macular thickness, and complications showed no statistically significant differences between the eplerenone and control groups (p = 0.43, 0.67, 0.64, and 0.12, respectively). The difference in the risk of complications occurring between the eplerenone and control groups also didn’t show statistical significance (p = 0.12). Conclusions Although eplerenone is not superior to a control protocol when considering anatomical improvements, the best-corrected visual acuity seems to improve up to 3 months superiorly compared to in the control group when oral eplerenone therapy is administered for central serous chorioretinopathy. In addition, the complications of eplerenone are tolerable. Therefore, clinically short-term use of eplerenone up to 3 months in central serous chorioretinopathy patients can be considered.