Background: Post-transplantation cyclophosphamide (PTCy) and anti-thymocyte globulin (ATG) are common pro‑ phylactic strategies for graft-versus-host disease (GVHD) after haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Interleukin (IL)-6 is a surrogate marker for cytokine release syndrome (CRS) and acute GVHD.Method The clinical outcomes and complications of haplo-HSCT with PTCy plus ATG versus PTCy monotherapy were compared according to serum IL-6 levels at Chungnam National University Hospital (Daejeon, South Korea) from Jan‑ uary 2019 to February 2023. Results: Forty patients who underwent haplo-HSCT were analyzed. A significant difference in IL-6 levels was observed between the PTCy plus ATG and PTCy alone groups (7.47 ± 10.55 vs. 117.65 ± 127.67; p = 0.003). More patients in the PTCy plus ATG group had a CRS grade of 0 than in the PTCy alone group (p < 0.001). Serum IL-6 levels were associated with grades II–IV acute GVHD (r = 0.547, p < 0.001). The cumulative incidence (CI) of grades II–IV acute GVHD was significantly higher in the PTCy alone group (67.9% vs. 4.8%; p < 0.001). No significant difference in the CI for chronic GVHD was detected between the PTCy plus ATG and PTCy alone groups (72.1% vs. 82.0%; p = 0.730). The CI of 1-year non-relapse mortality was significantly higher in the PTCy alone group than in the PTCy plus ATG group (42.2% vs. 15.9%; p = 0.022). The 1-year overall survival (OS) was significantly better in the PTCy plus ATG group (75.9% vs. 35.3%; p = 0.011). The 1-year GVHD-free, relapse-free survival rate was 29.4% in the PTCy alone group and 54.0% in the PTCy plus ATG group (p = 0.038). Conclusion Serum IL-6 levels were higher in the PTCy alone group than in the PTCy plus ATG group. The addition of ATG before stem cell infusion affected IL-6 levels and reduced the incidences of CRS and grade II–IV acute GVHD in haplo-HSCT patients. This study suggests that PTCy plus ATG as GVHD prophylaxis in haplo-HSCT is beneficial in terms of clinical outcomes and complications of HSCT.

Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients. Materials and Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided. Results: From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient. Conclusion Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.

Background: Despite the considerable disease burden due to trauma injury, sufficient effort has not been made for the assessment of nationwide trauma care status in Korea. We explored the feasibility of a diagnosis code-based injury severity measuring method in light of its realworld usage. Methods: We used datasets from the National Emergency Department Information System to calculate the survival risk ratios (SRRs) and the Korean Trauma Data Bank to predict models, respectively. The target cohort was split into training and validation datasets using stratified random sampling in an 8:2 ratio. We established six major mortality prediction models depending on the included parameters: 1) the Trauma and Injury Severity Score (TRISS) (age, sex, original Revised Trauma Score [RTS], Injury Severity Score [ISS]), 2) extended International Classification of Diseases-based Injury Severity Score (ICISS) 1 (age, sex, original RTS, ICISS using international SRRs), 3) extended ICISS 2 (age, sex, original RTS, ICISS using Korean SRRs based on 4-digit diagnosis codes), 4) extended ICISS 3 (age, sex, original RTS, ICISS using Korean SRRs based on full-digit diagnosis codes), 5) extended ICISS 4 (age, sex, modified RTS, and ICISS using Korean SRRs based on 4-digit diagnosis codes), 6) extended ICISS 5 (age, sex, modified RTS, and ICISS using Korean SRRs based on full-digit diagnosis codes). We estimated the model using training datasets and fitted it to the validation datasets. We measured the area under the receiver operating characteristic curve (AUC) for discriminative ability. Overall performance was also evaluated using the Brier score. Results: We observed the feasibility of the extended ICISS models, though their performance was slightly lower than the TRISS model (training cohort, AUC 0.936–0.938 vs. 0.949).Regarding SRR calculation methods, we did not find statistically significant differences.The alternative use of the Alert, Voice, Pain, Unresponsive Scale instead of the Glasgow Coma Scale in the RTS calculation did not degrade model performance. Conclusion The availability of the practical ICISS model was observed based on the model performance. We expect our ICISS model to contribute to strengthening the Korean Trauma Care System by utilizing mortality prediction and severity classification.

South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.

Background: Despite the considerable disease burden due to trauma injury, sufficient effort has not been made for the assessment of nationwide trauma care status in Korea. We explored the feasibility of a diagnosis code-based injury severity measuring method in light of its realworld usage. Methods: We used datasets from the National Emergency Department Information System to calculate the survival risk ratios (SRRs) and the Korean Trauma Data Bank to predict models, respectively. The target cohort was split into training and validation datasets using stratified random sampling in an 8:2 ratio. We established six major mortality prediction models depending on the included parameters: 1) the Trauma and Injury Severity Score (TRISS) (age, sex, original Revised Trauma Score [RTS], Injury Severity Score [ISS]), 2) extended International Classification of Diseases-based Injury Severity Score (ICISS) 1 (age, sex, original RTS, ICISS using international SRRs), 3) extended ICISS 2 (age, sex, original RTS, ICISS using Korean SRRs based on 4-digit diagnosis codes), 4) extended ICISS 3 (age, sex, original RTS, ICISS using Korean SRRs based on full-digit diagnosis codes), 5) extended ICISS 4 (age, sex, modified RTS, and ICISS using Korean SRRs based on 4-digit diagnosis codes), 6) extended ICISS 5 (age, sex, modified RTS, and ICISS using Korean SRRs based on full-digit diagnosis codes). We estimated the model using training datasets and fitted it to the validation datasets. We measured the area under the receiver operating characteristic curve (AUC) for discriminative ability. Overall performance was also evaluated using the Brier score. Results: We observed the feasibility of the extended ICISS models, though their performance was slightly lower than the TRISS model (training cohort, AUC 0.936–0.938 vs. 0.949).Regarding SRR calculation methods, we did not find statistically significant differences.The alternative use of the Alert, Voice, Pain, Unresponsive Scale instead of the Glasgow Coma Scale in the RTS calculation did not degrade model performance. Conclusion The availability of the practical ICISS model was observed based on the model performance. We expect our ICISS model to contribute to strengthening the Korean Trauma Care System by utilizing mortality prediction and severity classification.

South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.

Background: Post-transplantation cyclophosphamide (PTCy) and anti-thymocyte globulin (ATG) are common pro‑ phylactic strategies for graft-versus-host disease (GVHD) after haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Interleukin (IL)-6 is a surrogate marker for cytokine release syndrome (CRS) and acute GVHD.Method The clinical outcomes and complications of haplo-HSCT with PTCy plus ATG versus PTCy monotherapy were compared according to serum IL-6 levels at Chungnam National University Hospital (Daejeon, South Korea) from Jan‑ uary 2019 to February 2023. Results: Forty patients who underwent haplo-HSCT were analyzed. A significant difference in IL-6 levels was observed between the PTCy plus ATG and PTCy alone groups (7.47 ± 10.55 vs. 117.65 ± 127.67; p = 0.003). More patients in the PTCy plus ATG group had a CRS grade of 0 than in the PTCy alone group (p < 0.001). Serum IL-6 levels were associated with grades II–IV acute GVHD (r = 0.547, p < 0.001). The cumulative incidence (CI) of grades II–IV acute GVHD was significantly higher in the PTCy alone group (67.9% vs. 4.8%; p < 0.001). No significant difference in the CI for chronic GVHD was detected between the PTCy plus ATG and PTCy alone groups (72.1% vs. 82.0%; p = 0.730). The CI of 1-year non-relapse mortality was significantly higher in the PTCy alone group than in the PTCy plus ATG group (42.2% vs. 15.9%; p = 0.022). The 1-year overall survival (OS) was significantly better in the PTCy plus ATG group (75.9% vs. 35.3%; p = 0.011). The 1-year GVHD-free, relapse-free survival rate was 29.4% in the PTCy alone group and 54.0% in the PTCy plus ATG group (p = 0.038). Conclusion Serum IL-6 levels were higher in the PTCy alone group than in the PTCy plus ATG group. The addition of ATG before stem cell infusion affected IL-6 levels and reduced the incidences of CRS and grade II–IV acute GVHD in haplo-HSCT patients. This study suggests that PTCy plus ATG as GVHD prophylaxis in haplo-HSCT is beneficial in terms of clinical outcomes and complications of HSCT.

Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients. Materials and Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided. Results: From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient. Conclusion Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.

Background: Despite the considerable disease burden due to trauma injury, sufficient effort has not been made for the assessment of nationwide trauma care status in Korea. We explored the feasibility of a diagnosis code-based injury severity measuring method in light of its realworld usage. Methods: We used datasets from the National Emergency Department Information System to calculate the survival risk ratios (SRRs) and the Korean Trauma Data Bank to predict models, respectively. The target cohort was split into training and validation datasets using stratified random sampling in an 8:2 ratio. We established six major mortality prediction models depending on the included parameters: 1) the Trauma and Injury Severity Score (TRISS) (age, sex, original Revised Trauma Score [RTS], Injury Severity Score [ISS]), 2) extended International Classification of Diseases-based Injury Severity Score (ICISS) 1 (age, sex, original RTS, ICISS using international SRRs), 3) extended ICISS 2 (age, sex, original RTS, ICISS using Korean SRRs based on 4-digit diagnosis codes), 4) extended ICISS 3 (age, sex, original RTS, ICISS using Korean SRRs based on full-digit diagnosis codes), 5) extended ICISS 4 (age, sex, modified RTS, and ICISS using Korean SRRs based on 4-digit diagnosis codes), 6) extended ICISS 5 (age, sex, modified RTS, and ICISS using Korean SRRs based on full-digit diagnosis codes). We estimated the model using training datasets and fitted it to the validation datasets. We measured the area under the receiver operating characteristic curve (AUC) for discriminative ability. Overall performance was also evaluated using the Brier score. Results: We observed the feasibility of the extended ICISS models, though their performance was slightly lower than the TRISS model (training cohort, AUC 0.936–0.938 vs. 0.949).Regarding SRR calculation methods, we did not find statistically significant differences.The alternative use of the Alert, Voice, Pain, Unresponsive Scale instead of the Glasgow Coma Scale in the RTS calculation did not degrade model performance. Conclusion The availability of the practical ICISS model was observed based on the model performance. We expect our ICISS model to contribute to strengthening the Korean Trauma Care System by utilizing mortality prediction and severity classification.

South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.