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.

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.

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 and Objectives: Evidence regarding the efficacy and safety of intracardiac echocardiography (ICE) for guidance during transcatheter aortic valve replacement (TAVR) is limited. This study aimed to compare the clinical efficacy and safety of ICE versus transesophageal echocardiography (TEE) for guiding TAVR. Methods: This prospective cohort study included patients who underwent TAVR from August 18, 2015, to June 31, 2021. Eligible patients were stratified by echocardiographic modality (ICE or TEE) and anesthesia mode (monitored anesthesia care [MAC] or general anesthesia [GA]). Primary outcome was the 1-year composite of all-cause mortality, rehospitalization for cardiovascular cause, or stroke, according to the Valve Academic Research Consortium-3 (VARC-3) definition. Propensity score matching was performed, and study outcomes were analyzed for the matched cohorts. Results: Of the 359 eligible patients, 120 patients were matched for the ICE-MAC and TEEGA groups, respectively. The incidence of primary outcome was similar between matched groups (18.3% vs. 20.0%; adjusted hazard ratio, 0.94; 95% confidence interval [CI], 0.53– 1.68; p=0.843). ICE-MAC and TEE-GA also had similar incidences of moderate-to-severe paravalvular regurgitation (PVR) (4.2% vs. 5.0%; adjusted odds ratio, 0.83; 95% CI, 0.23– 2.82; p=0.758), new permanent pacemaker implantation, and VARC-3 types 2–4 bleeding. Conclusions ICE was comparable to TEE for guidance during TAVR for the composite clinical efficacy outcome, with similar incidences of moderate-to-severe PVR, new permanent pacemaker implantation, and major bleeding. These results suggest that ICE could be a safe and effective alternative echocardiographic modality to TEE for guiding TAVR.

Background and Objectives: Transcatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus. Methods: A total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared. Results: Between the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm2 , p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm2 /m2 , p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up. Conclusions TAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.

Background and Objectives: Transcatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus. Methods: A total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared. Results: Between the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm2 , p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm2 /m2 , p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up. Conclusions TAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.

OBJECTIVE: Posttraumatic embitterment disorder (PTED), a subgroup of an adjustment disorder, is a feeling with anger and helplessness. Hemodialysis may be a trigger event leading to PTED. We investigated the prevalence of PTED in patients with each categorized stages of chronic kidney disease (CKD) and the association between PTED and depression and functional impairment. METHODS: Patients were categorized into three groups according to the stages of CKD (stage I–II, III–IV, and V). CKD (I–II) group was defined as estimated glomerular filtration rate (eGFR) >60 ml/min/1.73 m², CKD (III–IV) group as eGFR <60 ml/min/1.73 m², and CKD (V) group as CKD stage V including patients ongoing hemodialysis. Patients were assessed for the prevalence of PTED, depression, and decreased quality of life by using the scale of PTED, Patient Health Questionnaire-9 (PHQ-9), and EuroQol Five Dimensional Questionnaires, Visual Analogue Scale (EQ-5D-VAS), respectively. RESULTS: A total of 445 patients were analyzed. The number of patients in CKD (I–II) was 166, CKD (III–IV) was 172, and CKD (V) was 107. Multivariate analysis by binomial logistic regression demonstrated that CKD (V) was significantly associated with the prevalence of PTED (odds ratio, 4.13; 95% confidence interval, 1.56–15.6; p=0.006) after adjustment for age, gender, and diabetes mellitus. Also, a significant correlation existed between PTED and EQ-5D-VAS in all stages, but the correlation was nonsignificant between PTED and PHQ-9 score in group CKD (V). CONCLUSION: The findings suggest that PTED is underdiagnosed in CKD patients. Acknowledgment and diagnosis of PTED in CKD patients may lead to a better quality of life.
Adjustment Disorders ; Anger ; Depression ; Diabetes Mellitus ; Diagnosis ; Dialysis ; Glomerular Filtration Rate ; Humans ; Logistic Models ; Multivariate Analysis ; Prevalence ; Quality of Life ; Renal Dialysis ; Renal Insufficiency, Chronic

The incidence rate of cervical cancer in Korea is still higher than in other developed countries, notwithstanding the national mass-screening program. Furthermore, a new method has been introduced in cervical cancer screening. Therefore, the committee for cervical cancer screening in Korea updated the recommendation statement established in 2002. The new version of the guideline was developed by the committee using evidence-based methods. The committee reviewed the evidence for the benefits and harms of the Papanicolaou test, liquid-based cytology, and human papillomavirus (HPV) testing, and reached conclusions after deliberation. The committee recommends screening for cervical cancer with cytology (Papanicolaou test or liquid-based cytology) every three years in women older than 20 years of age (recommendation A). The cervical cytology combined with HPV test is optionally recommended after taking into consideration individual risk or preference (recommendation C). The current evidence for primary HPV screening is insufficient to assess the benefits and harms of cervical cancer screening (recommendation I). Cervical cancer screening can be terminated at the age of 74 years if more than three consecutive negative cytology reports have been confirmed within 10 years (recommendation D).
Adult ; Age Factors ; Aged ; Early Detection of Cancer/adverse effects/*methods/standards ; Evidence-Based Medicine ; False Positive Reactions ; Female ; Humans ; Hysterectomy ; Middle Aged ; Papillomavirus Infections/diagnosis ; Papillomavirus Vaccines ; Patient Selection ; Pregnancy ; Pregnancy Complications, Neoplastic/diagnosis ; Republic of Korea ; Review Literature as Topic ; Uterine Cervical Neoplasms/*diagnosis ; Vaginal Smears/adverse effects/methods/standards ; Young Adult

The incidence rate of cervical cancer in Korea is still higher than in other developed countries, notwithstanding the national mass screening program. Furthermore, a new method has been introduced in cervical cancer screening. Therefore, the committee for cervical cancer screening in Korea updated the recommendation statement established in 2002. The new version of the guideline was developed by the committee using evidence-based methods. The committee reviewed the evidence for the benefits and harms of the Papanicolaou test, liquid-based cytology, and human papilloma virus (HPV) testing, and reached conclusions after deliberation. The committee recommends screening for cervical cancer with cytology (papanicolaou test or liquid-based cytology) every three years in women older than 20 years of age (recommendation A). The combination test (cytology with HPV test) is optionally recommended after taking into consideration individual risk or preference (recommendation C). The current evidence for primary HPV screening is insufficient to assess the benefits and harms of cervical cancer screening (recommendation I). Cervical cancer screening can be terminated at the age of 74 years if more than three consecutive negative cytology reports have been confirmed within ten years (recommendation D).
Developed Countries ; Female ; Humans ; Incidence ; Korea ; Mass Screening* ; Papanicolaou Test ; Papilloma ; Uterine Cervical Neoplasms*

This is the first study to investigate the influence of depression, anxiety and somatization on the treatment response for lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH). The LUTS/BPH patients were evaluated with the Korean versions of the International Prostate Symptom Score (IPSS), the Patient Health Questionnaire-9 (PHQ-9), the 7-item Generalized Anxiety Disorder Scale (GAD-7) and the PHQ-15. The primary endpoint was a responder rate defined by the total score of IPSS (< or = 7) at the end of treatment. The LUTS/BPH severity was significantly higher in patients with depression (whole symptoms P = 0.024; storage sub-symptom P = 0.021) or somatization (P = 0.024) than in those without, while the quality of life (QOL) was significantly higher in patients with anxiety (P = 0.038) than in those without. Anxious patients showed significantly higher proportion of non-response (odds ratio [OR], 3.294, P = 0.022) than those without, while somatic patients had a trend toward having more non-responders (OR, 2.552, P = 0.067). Our exploratory results suggest that depression, anxiety and somatization may have some influences on the clinical manifestation of LUTS/BPH. Further, anxious patients had a lower response to treatment in patients with LUTS/BPH. Despite of limitations, the present study demonstrates that clinicians may need careful evaluation of psychiatric symptoms for proper management of patients with LUTS/BPH.
Anxiety/epidemiology/*psychology ; Causality ; Comorbidity ; Depression/epidemiology/*psychology ; Humans ; Lower Urinary Tract Symptoms/epidemiology/prevention & control/*psychology ; Male ; Middle Aged ; Outcome Assessment (Health Care)/methods ; Prostatic Hyperplasia/epidemiology/*psychology/*therapy ; Psychometrics/methods ; Republic of Korea/epidemiology ; Risk Factors ; Severity of Illness Index ; Somatoform Disorders/epidemiology/*psychology ; Treatment Outcome