Objective: This study examined the mediating effect of negative changes in daily life due to the coronavirus disease-2019 (COVID-19) pandemic on depressive symptoms, considering COVID-19 infection and related social concerns. Additionally, comparisons of path coefficients between the groups were conducted based on age and gender. Methods: A cross-sectional study design used data from the 2020 Korean Community Health Survey consisting of 229,269 individuals. This study used a self-reported questionnaire, including the Patient Health Questionnaire-9 and three items addressing social concerns related to COVID-19 infection. A single question assessed whether individuals had experienced COVID-19 infection within the last 3 months, and scores of negative changes in daily life due to the COVID-19 pandemic. Correlation analysis was performed on the variables. Structural equation model analysis was conducted to identify the mediating role of negative changes in daily life. Chi-square tests were also performed to compare the path coefficients based on age and gender. Results: The structural equation models revealed that COVID-19 infection and related social concerns had both significant direct effects on depressive symptoms and indirect effects through negative changes in daily life. When comparing the path coefficients by age and gender, the coefficients related to depressive symptoms were highest in those under 65 years and in females. Conclusion Negative changes in daily life due to the COVID-19 pandemic serve as a partial mediator of the impact of COVID-19 infection and related social concerns on depressive symptoms. Special attention should be paid to depressive symptoms in those under 65 years of age and in females.

Objective: This study examined the mediating effect of negative changes in daily life due to the coronavirus disease-2019 (COVID-19) pandemic on depressive symptoms, considering COVID-19 infection and related social concerns. Additionally, comparisons of path coefficients between the groups were conducted based on age and gender. Methods: A cross-sectional study design used data from the 2020 Korean Community Health Survey consisting of 229,269 individuals. This study used a self-reported questionnaire, including the Patient Health Questionnaire-9 and three items addressing social concerns related to COVID-19 infection. A single question assessed whether individuals had experienced COVID-19 infection within the last 3 months, and scores of negative changes in daily life due to the COVID-19 pandemic. Correlation analysis was performed on the variables. Structural equation model analysis was conducted to identify the mediating role of negative changes in daily life. Chi-square tests were also performed to compare the path coefficients based on age and gender. Results: The structural equation models revealed that COVID-19 infection and related social concerns had both significant direct effects on depressive symptoms and indirect effects through negative changes in daily life. When comparing the path coefficients by age and gender, the coefficients related to depressive symptoms were highest in those under 65 years and in females. Conclusion Negative changes in daily life due to the COVID-19 pandemic serve as a partial mediator of the impact of COVID-19 infection and related social concerns on depressive symptoms. Special attention should be paid to depressive symptoms in those under 65 years of age and in females.

Objective: This study examined the mediating effect of negative changes in daily life due to the coronavirus disease-2019 (COVID-19) pandemic on depressive symptoms, considering COVID-19 infection and related social concerns. Additionally, comparisons of path coefficients between the groups were conducted based on age and gender. Methods: A cross-sectional study design used data from the 2020 Korean Community Health Survey consisting of 229,269 individuals. This study used a self-reported questionnaire, including the Patient Health Questionnaire-9 and three items addressing social concerns related to COVID-19 infection. A single question assessed whether individuals had experienced COVID-19 infection within the last 3 months, and scores of negative changes in daily life due to the COVID-19 pandemic. Correlation analysis was performed on the variables. Structural equation model analysis was conducted to identify the mediating role of negative changes in daily life. Chi-square tests were also performed to compare the path coefficients based on age and gender. Results: The structural equation models revealed that COVID-19 infection and related social concerns had both significant direct effects on depressive symptoms and indirect effects through negative changes in daily life. When comparing the path coefficients by age and gender, the coefficients related to depressive symptoms were highest in those under 65 years and in females. Conclusion Negative changes in daily life due to the COVID-19 pandemic serve as a partial mediator of the impact of COVID-19 infection and related social concerns on depressive symptoms. Special attention should be paid to depressive symptoms in those under 65 years of age and in females.

Objectives: This study examined the changes in the characteristics of high-risk suicide groups in South Korea before and after the COVID-19 pandemic using the Korean Cohort for the Model Predicting a Suicide and Suicide-related Behavior (K-COMPASS) cohort. Methods: The K-COMPASS is a longitudinal cohort study that started in 2015. The participants included suicide attempters and individuals with suicidal ideation from various hospitals and mental health centers in South Korea. This study compared the sociodemographic and psychiatric characteristics of 800 participants from the first cohort (2015–2019) with 511 participants from the second and third cohorts (2019–2024). Data were collected through structured interviews and validated scales. Results: The second and third cohort participants were younger, had a higher proportion of females, and exhibited more severe psychiatric symptoms and higher suicidal risk than the first cohort. The prevalence of physical illnesses decreased, while the use of psychiatric medications and the severity of mental health issues increased. In addition, significant sociodemographic changes were observed, such as higher educational levels and urban residency. Conclusion Significant shifts in the characteristics of high-risk suicide groups were observed during the COVID-19 pandemic, highlighting the need for targeted mental health interventions focusing on younger individuals and females to prevent suicide in high-risk groups.

Objectives: This study examined the changes in the characteristics of high-risk suicide groups in South Korea before and after the COVID-19 pandemic using the Korean Cohort for the Model Predicting a Suicide and Suicide-related Behavior (K-COMPASS) cohort. Methods: The K-COMPASS is a longitudinal cohort study that started in 2015. The participants included suicide attempters and individuals with suicidal ideation from various hospitals and mental health centers in South Korea. This study compared the sociodemographic and psychiatric characteristics of 800 participants from the first cohort (2015–2019) with 511 participants from the second and third cohorts (2019–2024). Data were collected through structured interviews and validated scales. Results: The second and third cohort participants were younger, had a higher proportion of females, and exhibited more severe psychiatric symptoms and higher suicidal risk than the first cohort. The prevalence of physical illnesses decreased, while the use of psychiatric medications and the severity of mental health issues increased. In addition, significant sociodemographic changes were observed, such as higher educational levels and urban residency. Conclusion Significant shifts in the characteristics of high-risk suicide groups were observed during the COVID-19 pandemic, highlighting the need for targeted mental health interventions focusing on younger individuals and females to prevent suicide in high-risk groups.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

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.

Background: Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests. Methods The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

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.