Objectives: This study was performed to evaluate the utilization patterns of acid suppressants following the withdrawal of ranitidine in Korea. Methods: Health Insurance Review & Assessment Service (HIRA) data from January 2016 to May 2023 were utilized to assess the usage of histamine H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) for acid-related diseases. Drug utilization was calculated for each agent based on the defined daily dose (DDD). To evaluate changes in utilization following the ranitidine recall, an interrupted time series analysis was conducted using segmented linear regression and an autoregressive integrated moving average model. Results: Before the withdrawal of ranitidine, the DDD per 100 000 inhabitants per day was increasing by 6.9 (95% confidence interval [CI], 4.7 to 9.0) for H2RAs and by 19.3 (95% CI, 16.9 to 21.8) for PPIs each month. After the recall, H2RA utilization immediately declined by -1041.7 (95% CI, -1115.8 to -967.7), followed by a monthly increase of 6.6 (95% CI, 3.7 to 9.6) above the previous trend. PPI utilization temporarily surged by 235.2 (95% CI, 149.1 to 321.3), then displayed a monthly increase of 4.1 (95% CI, 0.7 to 7.6) on top of the pre-recall trend. Among PPIs, esomeprazole and rabeprazole demonstrated notable increases, representing the most commonly used acid suppressants in 2023. Conclusions PPI usage rose prominently following the withdrawal of ranitidine from the market. Considering the potential adverse effects of PPIs, further research is necessary to evaluate the public health implications of shifts in the utilization of acid suppressants.

Background: This study aimed to estimate the association between mRNA coronavirus disease 2019 (COVID-19) vaccine exposure during pregnancy and the risks of preterm birth and congenital malformations leveraging a national population data. Methods: This retrospective cohort study utilized national data from the National Health Insurance System, linking maternal and infant records with COVID-19 vaccination registries.Newborns with congenital malformations were identified using diagnosis codes. The analysis included women aged 20–49 who gave live births between February 2022 and December 2022. Odds ratios (ORs) for preterm birth and any congenital malformation per COVID-19 vaccination during pregnancy compared to 1:4 matched unvaccinated controls, adjusted for maternal age, residential area, employment, income, disability, month of conception, prepregnancy obesity, smoking, and severe acute respiratory syndrome coronavirus 2 infection prior to pregnancy, were calculated. We compared the risk of two outcomes between BNT162b2 and mRNA-1273. Results: Among 106,692 women who gave birth during the study period, 8,966 (8.4%) received a COVID-19 vaccination during pregnancy. Of the newborns, 7,039 (6.6%) were preterm births and 7,658 (7.2%) had congenital malformations. COVID-19 vaccination during pregnancy was associated with a comparable risk of preterm birth (OR, 1.03; 95% confidence interval [CI], 0.77–1.36) and a similar risk of congenital malformations (0.90; 95% CI, 0.72–1.12) compared to non-vaccinees. The ORs of preterm birth (1.02; 95% CI, 0.77–1.36) and congenital malformation (0.91; 95% CI, 0.73–1.14) for mRNA-1273 were comparable to those for BNT162b2. Conclusion COVID-19 vaccines during pregnancy poses no increased risk of preterm birth and congenital malformations compared to those not exposed to the vaccine, with similar risk levels observed between the two mRNA vaccines. This finding provides additional evidence supporting the safety of COVID-19 vaccines.

Background: This study aimed to estimate the association between mRNA coronavirus disease 2019 (COVID-19) vaccine exposure during pregnancy and the risks of preterm birth and congenital malformations leveraging a national population data. Methods: This retrospective cohort study utilized national data from the National Health Insurance System, linking maternal and infant records with COVID-19 vaccination registries.Newborns with congenital malformations were identified using diagnosis codes. The analysis included women aged 20–49 who gave live births between February 2022 and December 2022. Odds ratios (ORs) for preterm birth and any congenital malformation per COVID-19 vaccination during pregnancy compared to 1:4 matched unvaccinated controls, adjusted for maternal age, residential area, employment, income, disability, month of conception, prepregnancy obesity, smoking, and severe acute respiratory syndrome coronavirus 2 infection prior to pregnancy, were calculated. We compared the risk of two outcomes between BNT162b2 and mRNA-1273. Results: Among 106,692 women who gave birth during the study period, 8,966 (8.4%) received a COVID-19 vaccination during pregnancy. Of the newborns, 7,039 (6.6%) were preterm births and 7,658 (7.2%) had congenital malformations. COVID-19 vaccination during pregnancy was associated with a comparable risk of preterm birth (OR, 1.03; 95% confidence interval [CI], 0.77–1.36) and a similar risk of congenital malformations (0.90; 95% CI, 0.72–1.12) compared to non-vaccinees. The ORs of preterm birth (1.02; 95% CI, 0.77–1.36) and congenital malformation (0.91; 95% CI, 0.73–1.14) for mRNA-1273 were comparable to those for BNT162b2. Conclusion COVID-19 vaccines during pregnancy poses no increased risk of preterm birth and congenital malformations compared to those not exposed to the vaccine, with similar risk levels observed between the two mRNA vaccines. This finding provides additional evidence supporting the safety of COVID-19 vaccines.

Objectives: This study was performed to evaluate the utilization patterns of acid suppressants following the withdrawal of ranitidine in Korea. Methods: Health Insurance Review & Assessment Service (HIRA) data from January 2016 to May 2023 were utilized to assess the usage of histamine H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) for acid-related diseases. Drug utilization was calculated for each agent based on the defined daily dose (DDD). To evaluate changes in utilization following the ranitidine recall, an interrupted time series analysis was conducted using segmented linear regression and an autoregressive integrated moving average model. Results: Before the withdrawal of ranitidine, the DDD per 100 000 inhabitants per day was increasing by 6.9 (95% confidence interval [CI], 4.7 to 9.0) for H2RAs and by 19.3 (95% CI, 16.9 to 21.8) for PPIs each month. After the recall, H2RA utilization immediately declined by -1041.7 (95% CI, -1115.8 to -967.7), followed by a monthly increase of 6.6 (95% CI, 3.7 to 9.6) above the previous trend. PPI utilization temporarily surged by 235.2 (95% CI, 149.1 to 321.3), then displayed a monthly increase of 4.1 (95% CI, 0.7 to 7.6) on top of the pre-recall trend. Among PPIs, esomeprazole and rabeprazole demonstrated notable increases, representing the most commonly used acid suppressants in 2023. Conclusions PPI usage rose prominently following the withdrawal of ranitidine from the market. Considering the potential adverse effects of PPIs, further research is necessary to evaluate the public health implications of shifts in the utilization of acid suppressants.

Background: This study aimed to estimate the association between mRNA coronavirus disease 2019 (COVID-19) vaccine exposure during pregnancy and the risks of preterm birth and congenital malformations leveraging a national population data. Methods: This retrospective cohort study utilized national data from the National Health Insurance System, linking maternal and infant records with COVID-19 vaccination registries.Newborns with congenital malformations were identified using diagnosis codes. The analysis included women aged 20–49 who gave live births between February 2022 and December 2022. Odds ratios (ORs) for preterm birth and any congenital malformation per COVID-19 vaccination during pregnancy compared to 1:4 matched unvaccinated controls, adjusted for maternal age, residential area, employment, income, disability, month of conception, prepregnancy obesity, smoking, and severe acute respiratory syndrome coronavirus 2 infection prior to pregnancy, were calculated. We compared the risk of two outcomes between BNT162b2 and mRNA-1273. Results: Among 106,692 women who gave birth during the study period, 8,966 (8.4%) received a COVID-19 vaccination during pregnancy. Of the newborns, 7,039 (6.6%) were preterm births and 7,658 (7.2%) had congenital malformations. COVID-19 vaccination during pregnancy was associated with a comparable risk of preterm birth (OR, 1.03; 95% confidence interval [CI], 0.77–1.36) and a similar risk of congenital malformations (0.90; 95% CI, 0.72–1.12) compared to non-vaccinees. The ORs of preterm birth (1.02; 95% CI, 0.77–1.36) and congenital malformation (0.91; 95% CI, 0.73–1.14) for mRNA-1273 were comparable to those for BNT162b2. Conclusion COVID-19 vaccines during pregnancy poses no increased risk of preterm birth and congenital malformations compared to those not exposed to the vaccine, with similar risk levels observed between the two mRNA vaccines. This finding provides additional evidence supporting the safety of COVID-19 vaccines.

Background: This study aimed to estimate the association between mRNA coronavirus disease 2019 (COVID-19) vaccine exposure during pregnancy and the risks of preterm birth and congenital malformations leveraging a national population data. Methods: This retrospective cohort study utilized national data from the National Health Insurance System, linking maternal and infant records with COVID-19 vaccination registries.Newborns with congenital malformations were identified using diagnosis codes. The analysis included women aged 20–49 who gave live births between February 2022 and December 2022. Odds ratios (ORs) for preterm birth and any congenital malformation per COVID-19 vaccination during pregnancy compared to 1:4 matched unvaccinated controls, adjusted for maternal age, residential area, employment, income, disability, month of conception, prepregnancy obesity, smoking, and severe acute respiratory syndrome coronavirus 2 infection prior to pregnancy, were calculated. We compared the risk of two outcomes between BNT162b2 and mRNA-1273. Results: Among 106,692 women who gave birth during the study period, 8,966 (8.4%) received a COVID-19 vaccination during pregnancy. Of the newborns, 7,039 (6.6%) were preterm births and 7,658 (7.2%) had congenital malformations. COVID-19 vaccination during pregnancy was associated with a comparable risk of preterm birth (OR, 1.03; 95% confidence interval [CI], 0.77–1.36) and a similar risk of congenital malformations (0.90; 95% CI, 0.72–1.12) compared to non-vaccinees. The ORs of preterm birth (1.02; 95% CI, 0.77–1.36) and congenital malformation (0.91; 95% CI, 0.73–1.14) for mRNA-1273 were comparable to those for BNT162b2. Conclusion COVID-19 vaccines during pregnancy poses no increased risk of preterm birth and congenital malformations compared to those not exposed to the vaccine, with similar risk levels observed between the two mRNA vaccines. This finding provides additional evidence supporting the safety of COVID-19 vaccines.

Objectives: This study was performed to evaluate the utilization patterns of acid suppressants following the withdrawal of ranitidine in Korea. Methods: Health Insurance Review & Assessment Service (HIRA) data from January 2016 to May 2023 were utilized to assess the usage of histamine H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) for acid-related diseases. Drug utilization was calculated for each agent based on the defined daily dose (DDD). To evaluate changes in utilization following the ranitidine recall, an interrupted time series analysis was conducted using segmented linear regression and an autoregressive integrated moving average model. Results: Before the withdrawal of ranitidine, the DDD per 100 000 inhabitants per day was increasing by 6.9 (95% confidence interval [CI], 4.7 to 9.0) for H2RAs and by 19.3 (95% CI, 16.9 to 21.8) for PPIs each month. After the recall, H2RA utilization immediately declined by -1041.7 (95% CI, -1115.8 to -967.7), followed by a monthly increase of 6.6 (95% CI, 3.7 to 9.6) above the previous trend. PPI utilization temporarily surged by 235.2 (95% CI, 149.1 to 321.3), then displayed a monthly increase of 4.1 (95% CI, 0.7 to 7.6) on top of the pre-recall trend. Among PPIs, esomeprazole and rabeprazole demonstrated notable increases, representing the most commonly used acid suppressants in 2023. Conclusions PPI usage rose prominently following the withdrawal of ranitidine from the market. Considering the potential adverse effects of PPIs, further research is necessary to evaluate the public health implications of shifts in the utilization of acid suppressants.

Purpose: To report a nationwide survey on neuroblastoma conducted by the Korean Association of Pediatric Surgeons (KAPS) in 2020. Methods: The clinical data of pediatric patients diagnosed with and treated for neuroblastoma from 2005 to 2019 in 19 hospitals of KAPS members were collected. Survival and prognostic factor analyses were performed using the log rank test and Cox proportional hazard analysis. A p-value <0.05 was considered significant. Results: A total of 669 patients with neuroblastoma were registered for the study. The results were presented and discussed at the 36th annual meeting of the KAPS, which was held in Seoul on August 21, 2020. Conclusion This study provides information on patient demographics, prognostic outcomes, and comprehensive treatment outcomes for neuroblastoma. The study is expected to be an important reference for improving pediatric surgeons’ understanding and treatment of neuroblastoma.

Purpose: Biliary atresia (BA) is a rare but progressive cholangiopathy and the leading cause of pediatric liver transplantation worldwide. The Korean Association of Pediatric Surgeons (KAPS) has conducted three national surveys (2001, 2011, and 2023) to assess long-term trends in the diagnosis, treatment, and outcomes of BA. This study provides a comparative analysis of the 2nd and 3rd national surveys, with reference to selected findings from the 1st survey. Methods: This study included 453 patients from the 3rd national survey (2011–2021) and 435 patients from the 2nd survey (2001–2010), all of whom underwent Kasai portoenterostomy. Data were collected via electronic case report forms from pediatric surgical centers nationwide. Comparisons were made regarding demographics, clinical features, diagnostic patterns, operative details, follow-up outcomes, and survival. Kaplan–Meier analysis was used to evaluate long-term survival. Results: The mean number of BA patients per year remained stable between surveys (43.5 in the 2nd, 41.18 in the 3rd), though centralization of care increased, with 61.5% of cases managed by two major institutions in the 3rd survey. The median age at surgery decreased, and the use of preoperative imaging (especially magnetic resonance cholangiopancreatography) increased. The 10-year native liver survival rate declined from 59.8% to 53.7%, while overall 10-year survival improved slightly (92.9% to 93.2%). Postoperative complications, such as cholangitis and liver failure, persisted but were better categorized. The 3rd survey also reported improved mortality (4.9%) and reduced follow-up loss (11.5%) compared to the 2nd survey. Conclusion While overall survival after Kasai operation has remained high and even improved, native liver survival has slightly declined. The findings reflect earlier diagnosis, more consistent diagnostic imaging, and increasing centralization of care. These trends underscore the importance of long-term nationwide data collection in guiding future strategies for BA management in Korea.

During the coronavirus disease 2019 (COVID-19) pandemic, conclusively evaluating possible associations between COVID-19 vaccines and potential adverse events was of critical importance. The National Academy of Medicine of Korea established the COVID-19 Vaccine Safety Research Center (CoVaSC) with support from the Korea Disease Control and Prevention Agency to investigate the scientific relationship between COVID-19 vaccines and suspected adverse events. Although determining whether the COVID-19 vaccine was responsible for any suspected adverse event necessitated a systematic approach, traditional causal inference theories, such as Hill's criteria, encountered certain limitations and criticisms. To facilitate a systematic and evidence-based evaluation, the United States Institute of Medicine, at the request of the Centers for Disease Control and Prevention, offered a detailed causality assessment framework in 2012, which was updated in the recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) in 2024.This framework, based on a weight-of-evidence approach, allows the independent evaluation of both epidemiological and mechanistic evidence, culminating in a comprehensive conclusion about causality. Epidemiological evidence derived from population studies is categorized into four levels—high, moderate, limited, or insufficient—while mechanistic evidence, primarily from biological and clinical studies in animals and individuals, is classified as strong, intermediate, weak, or lacking. The committee then synthesizes these two types of evidence to draw a conclusion about the causal relationship, which can be described as “convincingly supports” (“evidence established” in the 2024 NASEM report), “favors acceptance,” “favors rejection,” or “inadequate to accept or reject.” The CoVaSC has established an independent committee to conduct causality assessments using the weightof-evidence framework, specifically for evaluating the causality of adverse events associated with COVID-19 vaccines. The aim of this study is to provide an overview of the weight-ofevidence framework and to detail the considerations involved in its practical application in the CoVaSC.