• Korean Journal of Radiology
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• 제24권2호
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• pp.170-170
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• 2023

• 대한한의학원전학회지
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• 제23권4호
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• pp.63-102
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• 2010

Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

• Korean Journal of Radiology
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• 제23권8호
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• pp.828-834
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• 2022

Objective: This study aimed to assess the outcomes of outpatient day-care management of unruptured intracranial aneurysm (UIA), and to present the risks associated with different management strategies by comparing the outcomes and adverse events between outpatient day-care management and management with longer admission periods. Materials and Methods: This retrospective cohort study used prospectively registered data and was approved by a local institutional review board. We enrolled 956 UIAs from 811 consecutive patients (mean age ± standard deviation, 57 ± 10.7 years; male:female = 247:564) from 2017 to 2020. We compared the outcomes after embolization among the different admission-length groups (1, 2, and ≥ 3 days). The outcomes included pre- and post-modified Rankin Scale (mRS) scores and rates of adverse events, cure, recurrence, and reprocedure. Events were defined as any cerebrovascular problems, including minor and major stroke, death, or hemorrhage. Results: The mean admission period was 2 days, and 175 patients (191 aneurysms), 551 patients (664 aneurysms), and 85 patients (101 aneurysms) were discharged on the day of the procedure, day 2, and day 3 or later, respectively. During the mean 17-month follow-up period (range 6-53 months; 2757 patient years), no change in post-mRS was observed compared to pre-mRS in 99.6% of patients. Cure was achieved in 95.6% patients; minimal recurrence that did not require re-procedure occurred in 3.5% patients, and re-procedure was required in 2.3% (22 of 956) patients due to progressive enlargement of the recurrent sac during follow up (mean 17 months, range, 6-53 months). There were eight adverse events (0.8%), including five cerebrovascular (two major stroke, two minor strokes and one transient ischemic stroke), and three non-cerebrovascular events. Statistical comparison between groups with different admission lengths (1, 2, and ≥ 3 days) revealed no difference in the outcomes. Conclusion: This study revealed no difference in outcomes and adverse events according to the admission period, and suggested that UIA could be managed by outpatient day-care embolization.

• Safety and Health at Work
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• 제2권1호
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• pp.26-33
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• 2011

Objectives: The purpose of this retrospective cohort study was to investigate the relationship between exposure of Korean workers to petrochemicals in the refinery/petrochemical industry and lymphohematopoietic cancers. Methods: The cohort consisted of 8,866 male workers who had worked from the 1960s to 2007 at one refinery and six petrochemical companies located in a refinery/petrochemical complex in Korea that produce benzene or use benzene as a raw material. Standardized mortality ratios (SMRs) and standardized incidence ratios (SIRs) were calculated for 1992-2007 and 1997-2005 based on the death rate and cancer incidence rate of the Korean male population according to job title (production, maintenance, laboratory, and office workers). Results: The overall mortality and most cause-specific mortalities were lower among these workers than those of the general Korean population. Increased SMRs were observed for leukemia (4/1.45; SMR 2.77, 95% CI: 0.75-7.09) and lymphohematopoietic cancers (5/2.51; SMR 2, 95% CI: 0.65-4.66) in production workers, and increased SIRs were also observed in leukemia (3/1.34; SIR 2.24, 95% CI: 0.46-6.54) and lymphohematopoietic cancers (5/3.39; SIR 1.47, 95% CI: 0.48-3.44) in production workers, but the results were not statistically significant. Conclusion: The results showed a potential relationship between leukemia and lymphohematopoietic cancers and exposure to benzene in refinery/petrochemical complex workers. This study yielded limited results due to a short observational period; therefore, a follow-up study must be performed to elucidate the relationship between petrochemical exposure and cancer rates.

• Asian Pacific Journal of Cancer Prevention
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• 제14권5호
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• pp.2783-2787
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• 2013

To assess the risk of cancer incidence after medical radiation exposure for coronary artery disease (CAD), a retrospective cohort study was conducted based on Taiwan's National Health Insurance Research Database (NHIRD). Patients with CAD were identified according to the International Classification of Diseases code, 9th Revision, Clinical Modification (ICD-9-CM), and their records of medical radiation procedures were collected from 1997 to 2010. A total of 18,697 subjects with radiation exposure from cardiac imaging or therapeutic procedures for CAD were enrolled, and 19,109 subjects receiving cardiac diagnostic procedures without radiation were adopted as the control group. The distributions of age and gender were similar between the two populations. Cancer risks were evaluated by age-adjusted incidence rate ratio (aIRR) and association with cumulative exposure were further evaluated with relative risks by Poisson regression analysis. A total of 954 and 885 subjects with various types of cancers in both cohorts after following up for over 10 years were found, with incidences of 409.8 and 388.0 per 100,000 person-years, respectively. The risk of breast cancer (aIRR=1.85, 95% confidence interval: 1.14-3.00) was significantly elevated in the exposed female subjects, but no significant cancer risk was found in the exposed males. In addition, cancer risks of the breast and lung were increased with the exposure level. The study suggests that radiation exposure from cardiac imaging or therapeutic procedures for CAD may be associated with the increased risk of breast and lung cancers in CAD patients.

• Journal of Preventive Medicine and Public Health
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• 제49권3호
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• pp.176-182
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• 2016

Objectives: Prospective evaluations of the associations between depressive symptoms and suicide deaths have been mainly performed in high-risk populations, such as individuals with psychiatric disorders or histories of self-harm. The purpose of this study was to prospectively examine whether more severe depressive symptoms assessed using the Geriatric Depression Scale (GDS) were associated with a greater risk of death from suicide in a general-risk population. Methods: A total of 113 478 men from the Korean Veterans Health Study (mean age, 58.9 years) who participated in a postal survey in 2004 were followed up for suicide mortality until 2010. Results: Over 6.4 years of follow-up, 400 men died by suicide (56.7 deaths per 100 000 person-years). More severe depressive symptoms were associated with greater risk of suicide death (p for trend <0.001). The unadjusted hazard ratios (HRs) in comparison to the absence of depression were 2.18 for mild depression, 2.13 for moderate depression, 3.33 for severe depression, and 3.67 for extreme depression. After adjusting for potential confounders, men with a potential depressive disorder had an approximate 90% higher mortality from suicide (adjusted HR, 1.92; 95% confidence interval [CI], 1.38 to 2.68; p<0.001) than men without depression. Each five-point increase in the GDS score was associated with a higher risk of death by suicide (adjusted HR, 1.22; p<0.001). The value of the area under the receiver operating characteristics curve of GDS scores for suicide deaths was 0.61 (95% CI, 0.58 to 0.64). Conclusions: Depressive symptoms assessed using the GDS were found to be a strong independent predictor of future suicide. However, the estimate of relative risk was weaker than would be expected based on retrospective psychological autopsy studies.

• 대한두경부종양학회지
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• 제37권2호
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• pp.19-24
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• 2021

Background/Objectives: The aim of this national population-based retrospective study was to analyze the status and treatment outcome in patients with hypopharyngeal cancer. Materials & Methods: Participants were included in the KNHIS national sample cohort who received a KNHIS health check-up in 2008 and 2009, and we followed these individuals until 2017. Patients were defined as having hypopharynx cancer if they had admissions records for hypopharynx cancer in their national health insurance data from 2010 to 2017. Results: The study cohort included 3,922 patients. According to our nationwide data, 3,533(90.1%) were male with a median age of 65.03±11.04 years at the time of diagnosis. Among parametric models for hypopharyngeal cancer prognosis, old age (Hazard ratio [HR]:1.92; 95% confidence interval[CI]:1.76-2.09), female (HR:0.77; 95% CI:0.66-0.89), and low socioeconomic status (HR:1.216; 95% CI:1.114-1.327) were significantly associated with survival. Compared with concurrent chemoradiotherapy, patients who received no treatment (HR, 1.88; 95% CI, 1.31-2.70), neoadjuvant chemotherapy followed by surgery (HR, 1.21; 95% CI, 1.04-1.41), and chemotherapy alone (HR, 1.16; 95% CI, 1.03-1.27) showed poor prognosis in hypopharyngeal cancer. Conclusion: Our data indicated that age, sex, and income were significant predictors of lifetime survival in patients with hypopharyngeal cancer. Treatment modalities were also associated with prognosis. The data have implications for treatment investigations and prevention strategies.

• Archives of Plastic Surgery
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• 제49권5호
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• pp.569-579
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• 2022

Open and closed rhinoplasty are two main approaches to perform nasal modifications. According to current literature, there is no current consensus among plastic surgeons and otolaryngologists on which technique is preferred in terms of aesthetic result, complications, and patient satisfaction. This study uses published research to determine whether open or closed rhinoplasty leads to superior patient outcomes. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews were followed and a literature search was conducted in four databases based on our search strategy. Articles were then imported into COVIDENCE where they underwent primary screening and full-text review. Twenty articles were selected in this study after 243 articles were screened. There were 4 case series, 12 retrospective cohort studies, 1 prospective cohort study, 1 case-control, and 2 outcomes research. There were three cosmetic studies, eight functional studies, and nine studies that included both cosmetic and functional components. Sixteen studies utilized both open and closed rhinoplasty and four utilized open rhinoplasty. Both techniques demonstrated high patient and provider satisfaction and no advantage was found between techniques. Based on available studies, we cannot conclude if there is a preference between open or closed rhinoplasty in terms of which technique leads to better patient outcomes. Several studies determined that open rhinoplasty and closed rhinoplasty leads to comparative patient satisfaction. To make outcome reporting more reliable and uniform among studies, authors should look to utilize the Nasal Obstruction and Septoplasty Effectiveness scale and the Rhinoplasty Outcome Evaluation.

• 임상간호연구
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• 제28권2호
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• pp.167-176
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• 2022

Purpose: Driveline infection (DLI) is one of the major adverse events of Left Ventricular Assist Device (LVAD). The purpose of this study was to explore the incidence of DLI according to the driveline dressing methods. Methods: This study was a retrospective cohort study that investigated the medical records of 75 patients who implanted LVAD from January 2015 to December 2020 at a hospital in Seoul, Korea. Traditionally, sandwich dressing method was applied until October 2019, after which newly winded dressing method was adopted for driveline dressing to LVAD patients. The outcome variables were compared between sandwich dressing method applied group (n=41) and winded dressing method applied group (n=34). The follow-up period for DLI was 1 year. Results: When compared participants' characteristics, there was no difference between the two groups, except the type of LVAD device. The incidence of DLI was 17.1% in sandwich dressing group, while no infection was found in winded dressing group (p=.011). Conclusion: Although there were difference in the LVAD devices, it is considered that winded dressing contributed to the reduction of DLI. Further research on standardized dressing methods was required for DLI prevention in Korea.

• Journal of Chest Surgery
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• 제56권5호
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• pp.336-345
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• 2023

Background: The objective of this study was to demonstrate the safety, efficacy, and feasibility of intraoperative monitoring of the recurrent laryngeal nerves during thoracoscopic and robotic 3-field esophagectomy. Methods: This retrospective analysis details our initial experience using intraoperative nerve monitoring (IONM) during minimally invasive 3-field esophagectomy. Data were obtained from a prospectively maintained database and electronic medical records. The study included all patients who underwent minimally invasive (video-assisted thoracic surgery/robotic) transthoracic esophagectomy with neck anastomosis. The patients were divided into those who underwent IONM during the study period and a historical cohort who underwent 3-field esophagectomy without IONM at the same institution. Appropriate statistical tests were used to compare the 2 groups. Results: Twenty-four patients underwent nerve monitoring during minimally invasive 3-field esophagectomy. Of these, 15 patients underwent thoraco-laparoscopic operation, while 9 received a robot-assisted procedure. In the immediate postoperative period, 8 of 24 patients (33.3%) experienced vocal cord paralysis. Relative to a historical cohort from the same institution, who were treated with surgery without nerve monitoring in the preceding 5 years, a 26% reduction was observed in the nerve paralysis rate (p=0.08). On follow-up, 6 of the 8 patients with vocal cord paralysis reported a return to normal vocal function. Additionally, patients who underwent IONM exhibited a higher nodal yield and a decreased frequency of tracheostomy and bronchoscopy. Conclusion: The use of IONM during minimally invasive 3-field esophagectomy is safe and feasible. This technique has the potential to decrease the incidence of recurrent nerve palsy and increase nodal yield.