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: Health disparity is defined as a difference in the accessibility of medical resources among regions or other factors. In South Korea, there might be a disparity because of the low proportion of public medical institutions. This study aimed to investigate the geographic distribution of rehabilitation treatment and examine the factors associated with the rates of rehabilitation treatment in Korea. Methods: We used administrative claims data in 2007, 2012, and 2017 from the National Health Insurance Database in Korea. We defined physical therapy and occupational therapy as rehabilitation treatments and analyzed the rate of rehabilitation treatments for administrative districts in 2007, 2012, and 2017. Interdecile range and coefficient of variation were used to investigate the geographic distribution of rehabilitation treatment over time. We applied multiple random intercept negative binomial regression to examine the factors associated with rehabilitation treatment. A total of 28,319,614 inpatient and outpatient claims were submitted for 874 hospitals that provided rehabilitation treatment in 2007, 2012, and 2017. Results: The increase in the mean rates of physical therapy inpatients and outpatients was greater than those for occupational therapy inpatients and outpatients from 2007 to 2017. Both physical therapy and occupational therapy were concentrated in the Seoul Capital Area and other large urban areas. More than 30% of the districts received no rehabilitation treatment. The interdecile range and coefficient of variation for physical therapy declined more than those for occupational therapy from 2007 to 2017. The deprivation index was negatively correlated with physical therapy inpatients, physical therapy outpatients, occupational therapy inpatients, and occupational therapy outpatients. Furthermore, a 1-unit increase in the number of hospital beds per 1,000 people was associated with 1.42 times higher physical therapy inpatient, 1.44 times higher physical therapy outpatient, 2.14 times higher occupational therapy inpatient, and 3.30 times higher occupational therapy outpatient treatment. Conclusion To reduce the geographic inequality in rehabilitation treatment, it is necessary to narrow the gap between the supply and demand of rehabilitation services. Providing incentives or direct provisions from the government might be an alternative.

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

BACKGROUND: In Vitro follicular maturation (IVFM) of ovarian follicles is an emerging option for fertility preservation. Many paracrine factors and two-dimensional or three-dimensional (3D) environments have been used for optimization. However, since most studies were conducted using the murine model, the physiological differences between mice and humans limit the interpretation and adaptation of the results. Marmoset monkey is a non-human primate (NHPs) with more similar reproductive physiology to humans. In this study, we attempted to establish a 3D matrix (Matrtigel)-based IVFM condition for marmoset ovarian follicles in combination with anti-apoptotic factor, X-linked inhibitor of apoptosis protein (XIAP). METHODS: Marmoset follicles were isolated as individual follicles and cultured in a single drop with the addition of 0, 10, and 100 lg/mL of XIAP molecules. Matured oocytes and granulosa cells from mature follicles were collected and analyzed. The average number of isolated follicles was less than 100, and primordial and antral follicles were abundant in the ovaries. RESULTS: IVFM of marmoset follicles in 3D matrix conditions with XIAP increased the rates of survival and In Vitro follicle development. Furthermore, oocytes from the 3D cultures were successfully fertilized and developed In Vitro. The addition of XIAP increased the secretion of estradiol and aromatase. Furthermore, expression of granulosa-specific genes, such as bone morphogenetic protein 15, Oct4, and follicle-stimulating hormone receptor were upregulated in the In Vitro-matured follicles than in normal, well-grown, and atretic follicles. Apoptosis-related B-cell lymphoma-2 was highly expressed in the atretic follicles than in the XIAP-treated follicles, and higher caspase-3 was localized in the XIAP-treated follicles. CONCLUSION In this study, we attempted to establish a 3D-matrix-based marmoset IVFM condition and demonstrated the synergistic effects of XIAP. The use of a 3D matrix may be applied as an optimal culture condition for marmoset ovarian follicles.

Background and objectives: Takotsubo cardiomyopathy (TTC) occasionally causes life-threatening ventricular arrhythmia. J wave on surface electrocardiography (sECG) has also been associated with idiopathic ventricular fibrillation and cardiac events; therefore, we investigated whether the presence of J wave on sECG is a potential risk factor for ventricular arrhythmia in patients with TTC. Subjects and methods: We performed a retrospective study in 79 patients who were diagnosed with TTC from 2010 to 2014. Among them, 20 (25.3%) were diagnosed with ventricular tachycardia (VT). The J wave on the sECG was defined as J point elevation manifested through QRS notching or slurring at least 1 mm above the baseline in at least two leads. Results: A higher prevalence of ventricular tachycardia was observed in patients with J wave. The corrected QT interval (QTc) was significantly longer in the VT group than in the non-VT group. In a multivariate analysis, the presence of J wave appeared to be the only independent predictors of VT [Hazard Ratio (HR) 3.5, p = 0.019]. Conclusion Our results suggest that the presence of J wave on the sECG is significantly associated with VT, and appear to indicate that the presence of J wave is a strong and independent predictor of VT in patients with TTC.

Background: Cardiac rehabilitation (CR) after acute myocardial infarction (AMI) is recommended as a mandatory intervention in several national clinical practice guidelines published in America, Europe, and Korea to reduce recurrence and mortality. However, underutilization of CR is an established worldwide issue. In Korea, the promotion of CR is expected due to coverage by National Health Insurance. Nevertheless, the national status of CR use has not been reported. This retrospective cohort study aimed to investigate the current status of CR use in patients with AMI using nationwide data from the National Health Insurance Service of Korea. Methods: Patients with AMI admitted with the diagnosis of ‘I21’ code (from International Classification of Diseases, 10th revision, Clinical Modification) from July 1st, 2017 to June 30th, 2018 were included. CR use was defined as CR treatment or evaluation being performed during an outpatient follow-up period within 6 months after discharge. Participation rate and density were calculated nationally and by administrative division. Logistic regression analysis was performed to identify the influencing factors of CR participation. Results: Nationally, 1.5% of AMI patients (960/64,982) underwent CR during outpatient treatment after discharge. CR density was approximately 10. Logistic regression analysis revealed that influencing factors included old age, female sex, rural residence, and low Charlson comorbidity index. Conclusion Hospital-based CR after AMI is underutilized despite its coverage by the National Health Insurance. More CR facilities have to be installed according to the needs of CR in various regions.

BACKGROUND: For proper recovery from craniofacial fracture, it is necessary to establish guidelines based on trends. This study aimed to analyze the patterns and causes of craniofacial fractures. METHODS: This retrospective study analyzed patients who underwent surgery for craniofacial fractures between 2010 and 2017 at a single center. Several parameters, including time of injury, region and cause of fracture, alcohol intoxication, time from injury to surgery, hospitalization period, and postoperative complications, were evaluated. RESULTS: This study analyzed 2708 fracture lesions of 2076 patients, among whom males aged 10 to 39 years were the most numerous. The number of patients was significantly higher in the middle of a month. The most common fractures were a nasal bone fracture. The most common causes of fracture were ground accidents and personal assault, which tended to frequently cause more nasal bone fracture than other fractures. Traffic accidents and high falls tended to cause zygomatic arch and maxillary wall fractures more frequently. Postoperative complications—observed in 126 patients—had a significant relationship with the end of a month, mandible or panfacial fracture, and traffic accidents. CONCLUSIONS: The present findings on long-term craniofacial fracture trends should be considered by clinicians dealing with fractures and could be useful for policy decisions. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40902-018-0168-y) contains supplementary material, which is available to authorized users.
Accidental Falls ; Accidents, Traffic ; Hospitalization ; Humans ; Incidence ; Male ; Mandible ; Nasal Bone ; Postoperative Complications ; Retrospective Studies ; Zygoma

OBJECTIVE: We aimed to find the sex differences of the way how educational attainment influence on cognitive function in patients with Alzheimer's disease (AD). METHODS: We recruited 424 patients with AD from a large hospital-based multi-center cohort. We evaluated cognitive subdomains using the Seoul Neuropsychological Screening Battery-Dementia version. We employed multiple linear regression analysis to compare the score of cognitive subdomains between the groups with high versus low educational attainment based on the high school graduate. Interaction between educational attainment and sex was also included in the analysis. RESULTS: High and low educational attainment group had 33.0% and 67.0% of patients in the study population. In the multiple regression analysis, score of all cognitive subdomains were significantly higher in the high educational attainment group. The score of attention was also significantly affected by interaction between educational attainment and sex. This result may be helpful to develop cognitive intervention therapy. CONCLUSION: In the female patients with AD, educational attainment showed higher influence on the attention score.
Alzheimer Disease* ; Cognition ; Cohort Studies ; Dementia* ; Education* ; Female ; Humans ; Korea* ; Linear Models ; Mass Screening ; Seoul ; Sex Characteristics