1.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
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.
2.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
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.
3.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
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.
4.Atrial fibrillation fact sheet in Korea 2024(part 1): epidemiology of atrial fibrillation in Korea
So‑Ryoung LEE ; Daehoon KIM ; Sung Ho LEE ; Woo‑Hyun LIM ; Kwang Jin CHUN ; Won‑Seok CHOE ; Hyo‑Jeong AHN ; Kyung‑Yeon LEE ; JungMin CHOI ; Bong‑Seong KIM ; Kyung‑Do HAN ; Eue‑Keun CHOI
International Journal of Arrhythmia 2024;25(3):13-
Background and objectives:
This study aimed to analyze and present updated trends in atrial fibrillation (AF) epidemiology within the Korean population, providing a foundation for planning and implementing appropriate management and treatment strategies for patients with AF.
Patients and methods:
We used the Korean National Health Insurance Service database to evaluate the prevalence, incidence, comorbidities, and clinical adverse outcomes of patients with AF in Korea between 2013 and 2022.
Results:
AF prevalence in Korean adults aged ≥ 20 years doubled (1.1 to 2.2%) between 2013 and 2022, with significant increases observed across various sex and age groups. Similarly, the number of newly diagnosed patients with AF per year increased steadily, with the incidence rising from 184 to 275 per 100,000 person-years, particularly among older populations. Over this period, the mean age of patients with AF increased from 67.7 to 70.3 years, and comorbidities prevalence and CHA2DS2-VASc score rose significantly, indicating a higher stroke risk. Compared with patients without AF, AF was associated with an increased risk of mortality (hazard ratio [HR]: 1.78), ischemic stroke (HR: 2.39), major bleeding (HR: 2.10), myocardial infarction (HR: 1.44), and heart failure admission (HR: 2.42).
Conclusion
AF prevalence and incidence have steadily increased between 2013 and 2022, with a more pronounced increase in older patients. Patients with AF are increasingly becoming a high-risk population and are at increased risk of clinical adverse outcomes compared to non-AF patients. Therefore, a sustained national effort to improve AF awareness and comprehensive care quality for patients with AF is required.
5.Association between Beverage Intake and Obesity in Korean Adults in their 20s~30s
Yeon-Kyung LEE ; Hee-Kyong RO ; Young-Ran HEO ; Taisun HYUN ; Mi-Kyeong CHOI
Journal of the Korean Dietetic Association 2023;29(1):1-12
The purpose of this study was to investigate the association between daily beverage intake and obesity in young adults. This cross-sectional study was conducted with 256 adults in their 20s and 30s. Obesity was evaluated by anthropometric measurement of body mass index (BMI), waist to hip ratio and waist to height ratio. In addition, the daily intake of milk, caffeinated beverages, sweetened beverages, and alcoholic beverages was investigated using the dietary record and 24-h recall methods. Based on the BMI, men and women were classified into underweight, normal, overweight and obese. Among men, 38.3% were found to be normal, 28.1% were overweight and 31.3% obese. Among women, 11.7% were underweight, 73.4% were normal, and 10.2% were overweight, which was significantly different from men. In women, the BMI of the milk consumers was significantly lower than the non-consumers. Also, the obesity indices of caffeinated beverage consumers were significantly lower than the non-consumers. An analysis of the correlation between beverage intake and the obesity index showed that the intake of caffeinated beverages among women had a significant negative correlation with the obesity index, and intake of alcoholic beverages had a significant positive correlation with waist to height ratio. This study suggests that intake of milk and caffeinated beverage may have a positive effect on obesity, whereas the intake of alcoholic beverages may have a negative effect, especially in young adult women.
6.Comparison between 24-hour diet recall and 24-hour urine collection for estimating sodium and potassium intakes and their ratio among Korean adults
Taisun HYUN ; Mi-Kyeong CHOI ; Young-Ran HEO ; Heekyong RO ; Young-Hee HAN ; Yeon-Kyung LEE
Nutrition Research and Practice 2023;17(2):284-296
BACKGROUND/OBJECTIVES:
This study aimed to compare 24-h diet recall (DR) and 24-h urine collection (UC) for estimating sodium and potassium intakes and their ratio (Na/K), identifying factors associated with sodium and potassium intakes and Na/K, and identifying those who were likely to underestimate sodium and potassium intakes by DR.
SUBJECTS/METHODS:
A total of 640 healthy adults aged 19–69 yrs completed a questionnaire survey, salty taste assessment, anthropometric measurement, two 24-h DRs, and two 24-h UCs.
RESULTS:
The mean sodium and potassium intakes and Na/K were 3,755 mg/d, 2,737 mg/d, and 1.45 according to DR, and 4,145 mg/d, 2,812 mg/d, and 1.57 according to UC, with percentage differences of −9.4%, −2.7%, and −7.6% in the values between the two methods, respectively.Men, older adults, smokers, obese individuals, those who consumed all the liquid in the soup, and those who were found to be salty in the salty taste assessment consumed significantly more sodium; older adults, the heavy- activity group, and obese individuals consumed more potassium; and men, younger adults, smokers, and obese individuals had a significantly higher Na/K, according to UC. Compared with UC, DR was more likely to underestimate sodium intake in older adults, smokers, obese individuals, those who consumed all the liquid in the soup, and those who consumed eating-out/delivery food at least once a day, and potassium intake in older adults, the heavy-activity group, and obese individuals.
CONCLUSIONS
The mean sodium and potassium intakes and Na/K estimated by DR were comparable to those measured by UC. However, the association of sodium and potassium intakes with sociodemographic and health-related factors showed inconsistent results when estimated by DR and UC. Factors influencing the underestimation of sodium intake by DR compared to UC should be further investigated.
7.Duo‑decapolar catheter entrapment in the Chiari network: successful extraction with the snare catheter
Kyung‑Yeon LEE ; Tae‑Min RHEE ; So‑Ryoung LEE ; Eue‑Keun CHOI ; Seil OH
International Journal of Arrhythmia 2023;24(3):18-
Background:
The Chiari network (CN) is the net-like embryonic remnants of the right valve of the sinus venosus.Catheter entrapment by CN is a not uncommon complication during catheter manipulation inside the right atrium (RA).Case presentation A 49-year-old man with atrial fibrillation was admitted for cryoablation. Transesophageal echo‑ cardiography revealed a prominent CN in the RA. Through the sheath placed in the right femoral vein, a diagnostic electrophysiologic duo-decapolar (DD) catheter (Livewire, St Jude Medical, St Paul, MN) was advanced. The catheter tip was knotted after multiple rotations in the RA to properly locate the DD catheter at the RA wall and coronary sinus (CS). Initial attempts to disentangle the folded catheter tip by traction and rotation maneuvers were unsuccessful.We inserted the large-bore sheath (Sentrant; Medtronic, 20 Fr) into the patient’s left femoral vein and then, captured the folded catheter tip with the 20-mm circular snare catheter (Snare Kit, Medtronic, Minneapolis, MN). Then, we cut the proximal portion of the DD catheter externally and removed it retrogradely through the Flexcath sheath. We found that the catheter tip was entrapped by the fibrous tissue of the CN. After a successful retrieval, cryoablation was conducted as planned. Follow-up echocardiography did not reveal any peri-procedural complications.
Conclusions
The electrophysiological procedure that exists at the RA entails a potential risk of catheter entrapment manipulating the catheter at the RA. If catheter entrapment occurs during the procedure, the entrapped catheter may be removed via a large-bore sheath using a snare catheter.
8.Risk Factors Associated with Medication Adherence in HIV/AIDS Patients
Kyung Sun OH ; Jin-soo LEE ; Euna HAN
Korean Journal of Clinical Pharmacy 2023;33(4):254-260
Background:
Adherence to antiretroviral treatment (ART) is crucial for maintaining the HIV-RNA suppression in patients living with HIV/AIDS. This study aims to analyze the risk factors contributing to low medication adherence among individuals with HIV/ AIDS by analyzing data from the Korean HIV/AIDS cohort study.
Methods:
The dependent variable is ART medication adherence.The depressive symptom and anxiety scores were collected as main independence variables. Covariates included gender, age, transmission route, alcohol and smoking information, and antiviral treatment regimen details. To predict the relationship between ordinal dependent variables and independent variables, an ordered logistic regression analysis was conducted, and odds ratios (OR) were calculated.
Results:
The results of the ordered logistic regression analysis showed that female was associated with a higher risk of low medication adherence (OR=2.91, 95% CI=1.08, 7.83). Among the subjects who were non-smokers and non-drinkers, the risk of low medication adherence was lower (OR=0.36, 95% CI=0.18, 0.70). Depending on the ART treatment group, individuals taking integrase inhibitor had a lower risk of medication adherence (OR=0.31, 95% CI=0.13, 0.76), and those experiencing depressive symptoms were related with a higher risk of low medication adherence (OR=1.97, 95% CI=1.12, 3.46).
Conclusions
The encouragement and emotional support of healthcare professionals are essential for patients living with HIV/AIDS who experience depressive symptoms to maintain ART adherence. Additionally, further research is needed to ensure that HIV/AIDS infected female with concurrent depressive symptoms can achieve appropriate ART therapeutic effect.
9.Safety of acupotomy in a real-world setting: A prospective pilot and feasibility study.
Sang-Hoon YOON ; Chan-Young KWON ; Hee-Geun JO ; Jae-Uk SUL ; Hyangsook LEE ; Jiyoon WON ; Su Jin JEONG ; Jun-Hwan LEE ; Jungtae LEEM
Journal of Integrative Medicine 2022;20(6):514-523
OBJECTIVE:
Acupotomy is a modern acupuncture method that includes modern surgical methods. Since acupotomy is relatively more invasive than filiform acupuncture treatment, it is important to establish the safety profile of this practice. To justify further large-scale prospective observational studies, this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events (AEs).
METHODS:
This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting. The feasibility (call response rate, drop-out rate, response rate for each variable and recruitment per month) and safety profile (incidence, type, severity and causality of AEs, and factors potentially associated with AEs) were measured.
RESULTS:
A total of 28 participants joined the study from January to May 2018. A follow-up assessment was achieved in 258 (1185 treatment points) out of 261 sessions (1214 treatment points). The response rate via telephone on the day after treatment was 87.3%. There were 8 systemic AEs in all the sessions (8/258; 3.11%) and 27 local AEs on the total points treated (27/1185; 2.28%). Severe AEs did not occur. Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point.
CONCLUSION:
The findings suggest that it could be feasible to analyze the safety of acupotomy in a real-world setting. Moreover, the primary data on some relevant AEs could be determined. We are planning large-scale prospective studies based on these findings.
TRIAL REGISTRATION
Clinical Research Information Service (CRIS) KCT0002849 (https://cris.nih.go.kr/cris/search/detailSearch.do/11487).
Humans
;
Feasibility Studies
;
Prospective Studies
;
Pilot Projects
;
Acupuncture Therapy/methods*
;
Research Design
;
Treatment Outcome
10.Development and application of the sodium index to estimate and assess sodium intake for Korean adults
Yeon-Kyung LEE ; Taisun HYUN ; Heekyong RO ; Young-Ran HEO ; Mi-Kyeong CHOI
Nutrition Research and Practice 2022;16(3):366-378
BACKGROUND/OBJECTIVES:
The purpose of this study was to develop a sodium index, which is a tool for estimating and assessing sodium intake easily and quickly, to assist in the prevention of various diseases induced by excess sodium intake in Korean adults.
SUBJECTS/METHODS:
The 24-h urine collection and dietary behavior surveys were performed on 640 healthy people in 4 regions of South Korea, and an equation for the estimation of 24-h sodium intake was developed. The validity and reliability of the equation were verified with 200 adults. The sodium index was developed by converting the estimated sodium intake using the equation. Finally, the sodium intake status of 1,600 adults was assessed using the sodium index.
RESULTS:
The equation included sex, age, body mass index, eating habit and dietary behaviors related to sodium intake. In validity test of the equation, the mean bias between sodium intake using 24-h urine analysis and using the equation from the Bland-Altman plots was −1.5 mg/day. The sensitivity and specificity of the equation for estimation of sodium intake were 80.5% and 64.4%, respectively. In the reliability test of the equation, there was no significant difference between the first and second sodium intakes calculated using the equations, and Spearman's correlation coefficient between the 2 sodium intakes was 0.98. Sodium intake can be assessed as ‘very moderate’ for 75–100 on the sodium index, ‘moderate’ for 100–150, ‘careful’ for less than 75 or 150–200, and ‘severe’ for 250 or more. When sodium intake was assessed using the sodium index in 1,600 subjects, 54.3% and 24.3% of the subjects were assessed to be in the ‘careful’ and ‘severe’ categories, respectively.
CONCLUSIONS
Using a simple questionnaire, the sodium index can be used to monitor and assess sodium intake status, assisting in nutrition education and counseling in a large population.

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