1.In Vitro Diagnostics Certification for Creatinine Assays in Korea over 7 Years: Achievements and Future Outlook
Eun-Jung CHO ; Joonsang YU ; Jeayeon RYU ; Jiwoo SEO ; Hyunae LEE ; Chan-Ik CHO ; Tae-Dong JEONG ; Sollip KIM ; Woochang LEE ; Sail CHUN ; Won-Ki MIN
Annals of Laboratory Medicine 2025;45(5):493-502
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.
2.Major clinical research advances in gynecologic cancer in 2023:a tumultuous year for endometrial cancer
Seung-Hyuk SHIM ; Jung-Yun LEE ; Yoo-Young LEE ; Jeong-Yeol PARK ; Yong Jae LEE ; Se Ik KIM ; Gwan Hee HAN ; Eun Jung YANG ; Joseph J NOH ; Ga Won YIM ; Joo-Hyuk SON ; Nam Kyeong KIM ; Tae-Hyun KIM ; Tae-Wook KONG ; Youn Jin CHOI ; Angela CHO ; Hyunji LIM ; Eun Bi JANG ; Hyun Woong CHO ; Dong Hoon SUH
Journal of Gynecologic Oncology 2024;35(2):e66-
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.
3.Time-dependent Efficacy and Safety of Eplerenone for Central Serous Chorioretinopathy:Meta-analysis of Randomized Controlled Clinical Trials
Gyudeok HWANG ; Ji Young LEE ; Won-Kyung CHO ; Dae Seon KIM ; Dong Ik KIM ; Jeong Ah SHIN
Journal of Retina 2024;9(1):41-51
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.
4.Major clinical research advances in gynecologic cancer in 2023:a tumultuous year for endometrial cancer
Seung-Hyuk SHIM ; Jung-Yun LEE ; Yoo-Young LEE ; Jeong-Yeol PARK ; Yong Jae LEE ; Se Ik KIM ; Gwan Hee HAN ; Eun Jung YANG ; Joseph J NOH ; Ga Won YIM ; Joo-Hyuk SON ; Nam Kyeong KIM ; Tae-Hyun KIM ; Tae-Wook KONG ; Youn Jin CHOI ; Angela CHO ; Hyunji LIM ; Eun Bi JANG ; Hyun Woong CHO ; Dong Hoon SUH
Journal of Gynecologic Oncology 2024;35(2):e66-
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.
5.Major clinical research advances in gynecologic cancer in 2023:a tumultuous year for endometrial cancer
Seung-Hyuk SHIM ; Jung-Yun LEE ; Yoo-Young LEE ; Jeong-Yeol PARK ; Yong Jae LEE ; Se Ik KIM ; Gwan Hee HAN ; Eun Jung YANG ; Joseph J NOH ; Ga Won YIM ; Joo-Hyuk SON ; Nam Kyeong KIM ; Tae-Hyun KIM ; Tae-Wook KONG ; Youn Jin CHOI ; Angela CHO ; Hyunji LIM ; Eun Bi JANG ; Hyun Woong CHO ; Dong Hoon SUH
Journal of Gynecologic Oncology 2024;35(2):e66-
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.
6.Practice guidelines for managing extrahepatic biliary tract cancers
Hyung Sun KIM ; Mee Joo KANG ; Jingu KANG ; Kyubo KIM ; Bohyun KIM ; Seong-Hun KIM ; Soo Jin KIM ; Yong-Il KIM ; Joo Young KIM ; Jin Sil KIM ; Haeryoung KIM ; Hyo Jung KIM ; Ji Hae NAHM ; Won Suk PARK ; Eunkyu PARK ; Joo Kyung PARK ; Jin Myung PARK ; Byeong Jun SONG ; Yong Chan SHIN ; Keun Soo AHN ; Sang Myung WOO ; Jeong Il YU ; Changhoon YOO ; Kyoungbun LEE ; Dong Ho LEE ; Myung Ah LEE ; Seung Eun LEE ; Ik Jae LEE ; Huisong LEE ; Jung Ho IM ; Kee-Taek JANG ; Hye Young JANG ; Sun-Young JUN ; Hong Jae CHON ; Min Kyu JUNG ; Yong Eun CHUNG ; Jae Uk CHONG ; Eunae CHO ; Eui Kyu CHIE ; Sae Byeol CHOI ; Seo-Yeon CHOI ; Seong Ji CHOI ; Joon Young CHOI ; Hye-Jeong CHOI ; Seung-Mo HONG ; Ji Hyung HONG ; Tae Ho HONG ; Shin Hye HWANG ; In Gyu HWANG ; Joon Seong PARK
Annals of Hepato-Biliary-Pancreatic Surgery 2024;28(2):161-202
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.
7.Major clinical research advances in gynecologic cancer in 2022: highlight on late-line PARP inhibitor withdrawal in ovarian cancer, the impact of ARIEL-4, and SOLO-3
Jung-Yun LEE ; Yoo-Young LEE ; Jeong-Yeol PARK ; Seung-Hyuk SHIM ; Se Ik KIM ; Tae-Wook KONG ; Chul Kwon LIM ; Hyun Woong CHO ; Dong Hoon SUH
Journal of Gynecologic Oncology 2023;34(2):e51-
In the 2022 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) Ovarian cancer: long-term follow-up data, new poly (ADP-ribose) polymerase (PARP) inhibitors, overall survival (OS) issues with PARP inhibitor monotherapy, hyperthermic intraperitoneal chemotherapy, immunotherapy, and antibody-drug conjugate; 2) Cervical cancer: surgery in early stage disease, therapy for locally advanced stage and advanced, metastatic, or recurrent setting; and 3) Corpus cancer: follow-up regimen, immune checkpoint inhibitor, WEE1 inhibitor, selective inhibitor of nuclear export. A special note was made on the withdrawal of PARP inhibitor from the market for heavily pretreated ovarian cancer patients based on the final OS results of ARIEL-4 and SOLO-3 due to concerns of increased risk of death.
8.Endoscopist-Driven Sedation Practices in South Korea:Re-evaluation Considering the Nationwide Survey in 2019
Seon-Young PARK ; Jun Kyu LEE ; Chang-Hwan PARK ; Byung-Wook KIM ; Chang Kyun LEE ; Hong Jun PARK ; Byung Ik JANG ; Dong Uk KIM ; Jin Myung PARK ; Jae Min LEE ; Young Sin CHO ; Hyung Ku CHON ; Seung Young SEO ; Woo Hyun PAIK ; The Committees of Quality Management and Conscious Sedation of Korean Society of Gastrointestinal En
Gut and Liver 2022;16(6):899-906
Background/Aims:
This study aimed to determine changes in endoscopist-driven sedation practices 5 years after the first nationwide survey in 2014 by the Korean Society of Gastrointestinal Endoscopy (KSGE).
Methods:
A 59-item survey covering current practices was electronically mailed to all members of the KSGE in 2019.
Results:
In total, 955 (12.8%) out of 7,486 questionnaires were returned. A total of 738 (77.7%) out of 955 respondents attended dedicated sedation education programs. The American Society of Anesthesiologists class was recorded by 464 (51.2%) out of 907 respondents. The recording rate was higher in respondents who completed sedation education (p=0.014) and worked in general or tertiary hospitals (p<0.001). Compared to that reported in the previous survey, the reported use of propofol was higher in 2019. The respondents had higher satisfaction scores for propofol-based sedation compared with midazolam monotherapy (p<0.001). The rates of oxygen supplementation (p<0.001) and oxygen saturation level monitoring (p<0.001) during sedative endoscopy were higher in 2019 than in the previous survey. A total of 876 (98.4%) out of 890 respondents reported a separate recovery bay, and 615 (70.5%) out of 872 respondents reported that personnel were assigned solely to the recovery bay.
Conclusions
Endoscopist-driven sedation and monitoring practices in 2019 were significantly different than those in 2014. The respondents favored propofol-based sedation and utilized oxygen supplementation and monitoring of O2 saturation more frequently in 2019 than in 2014.
9.Prediction of Early Recanalization after Intravenous Thrombolysis in Patients with Large-Vessel Occlusion
Young Dae KIM ; Hyo Suk NAM ; Joonsang YOO ; Hyungjong PARK ; Sung-Il SOHN ; Jeong-Ho HONG ; Byung Moon KIM ; Dong Joon KIM ; Oh Young BANG ; Woo-Keun SEO ; Jong-Won CHUNG ; Kyung-Yul LEE ; Yo Han JUNG ; Hye Sun LEE ; Seong Hwan AHN ; Dong Hoon SHIN ; Hye-Yeon CHOI ; Han-Jin CHO ; Jang-Hyun BAEK ; Gyu Sik KIM ; Kwon-Duk SEO ; Seo Hyun KIM ; Tae-Jin SONG ; Jinkwon KIM ; Sang Won HAN ; Joong Hyun PARK ; Sung Ik LEE ; JoonNyung HEO ; Jin Kyo CHOI ; Ji Hoe HEO ;
Journal of Stroke 2021;23(2):244-252
Background:
and Purpose We aimed to develop a model predicting early recanalization after intravenous tissue plasminogen activator (t-PA) treatment in large-vessel occlusion.
Methods:
Using data from two different multicenter prospective cohorts, we determined the factors associated with early recanalization immediately after t-PA in stroke patients with large-vessel occlusion, and developed and validated a prediction model for early recanalization. Clot volume was semiautomatically measured on thin-section computed tomography using software, and the degree of collaterals was determined using the Tan score. Follow-up angiographic studies were performed immediately after t-PA treatment to assess early recanalization.
Results:
Early recanalization, assessed 61.0±44.7 minutes after t-PA bolus, was achieved in 15.5% (15/97) in the derivation cohort and in 10.5% (8/76) in the validation cohort. Clot volume (odds ratio [OR], 0.979; 95% confidence interval [CI], 0.961 to 0.997; P=0.020) and good collaterals (OR, 6.129; 95% CI, 1.592 to 23.594; P=0.008) were significant factors associated with early recanalization. The area under the curve (AUC) of the model including clot volume was 0.819 (95% CI, 0.720 to 0.917) and 0.842 (95% CI, 0.746 to 0.938) in the derivation and validation cohorts, respectively. The AUC improved when good collaterals were added (derivation cohort: AUC, 0.876; 95% CI, 0.802 to 0.950; P=0.164; validation cohort: AUC, 0.949; 95% CI, 0.886 to 1.000; P=0.036). The integrated discrimination improvement also showed significantly improved prediction (0.097; 95% CI, 0.009 to 0.185; P=0.032).
Conclusions
The model using clot volume and collaterals predicted early recanalization after intravenous t-PA and had a high performance. This model may aid in determining the recanalization treatment strategy in stroke patients with large-vessel occlusion.
10.The predictors of sustained virological response with sofosbuvir and ribavirin in patients with chronic hepatitis C genotype 2
Sung Yong HAN ; Hyun Young WOO ; Jeong HEO ; Sang Gyu PARK ; Sung Ik PYEON ; Young Joo PARK ; Dong Uk KIM ; Gwang Ha KIM ; Hyung Hoi KIM ; Geun Am SONG ; Mong CHO
The Korean Journal of Internal Medicine 2021;36(3):544-556
Background/Aims:
Real-world, clinical practice data are lacking about sofosbuvir/ ribavirin (SOF/RBV) treatment of Korean patients with hepatitis C virus genotype 2 (HCV GT2) infection. This study investigated the efficacy and safety of SOF/RBV in Korean patients with HCV GT2 infection and clinical factors predicting sustained virological response 12 weeks (SVR12) after the end of SOF/RBV treatment.
Methods:
A total of 181 patients with HCV GT2 with/without cirrhosis were treated with SOF/RBV for 16/12 weeks. Rapid virological response (RVR) was defined as non-detectable HCV RNA at 4 weeks.
Results:
The RVR rate was 80.7% (146/181), the end of treatment response rate was 97.8% (177/181) and the SVR12 rate was 92.8% (168/181). Of eight patients with relapse, four did not achieve RVR. Three patients had a history of hepatocellular carcinoma (HCC). Multivariable analysis showed that RVR (p = 0.015) and no previous history of HCC (p = 0.007) were associated with SVR12. Factors significantly contributing to RVR included cirrhosis, creatinine concentration, and pre-treatment HCV RNA level. SVR12 rate was significantly higher in RVR (+) than RVR (–) patients (95.2% vs. 82.9%, p = 0.011) and also significantly higher in patients without than with a history of HCC (94.1% vs. 72.7%, p = 0.008). During treatment, 80/181 patients (44.2%) experienced mild to moderate adverse events, with 32 (17.7%) requiring RBV dose reductions due to anemia.
Conclusions
SOF/RBV treatment was effective and tolerable in HCV GT2 patients. RVR and no previous history of HCC were positive predictors of SVR12.

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