• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.336-341
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• 1994

Multicenter controlled clinical trials require It synthesis of the scientific method and the precepts of modern management. The management tasks associated with these studies are akin to those found in other kinds of complex corporate endeavors. It is recommended that clinical investigators become more knowledgeable about management concepts and methods and management specialists be given a major role in the planning and conduct of large-scale clinical trials.

• Clinical and Experimental Pediatrics
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• v.63 no.1
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• pp.3-7
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• 2020

High-flow nasal cannula (HFNC) is a relatively safe and effective noninvasive ventilation method that was recently accepted as a treatment option for acute respiratory support before endotracheal intubation or invasive ventilation. The action mechanism of HFNC includes a decrease in nasopharyngeal resistance, washout of dead space, reduction in inflow of ambient air, and an increase in airway pressure. In preterm infants, HFNC can be used to prevent reintubation and initial noninvasive respiratory support after birth. In children, flow level adjustments are crucial considering their maximal efficacy and complications. Randomized controlled studies suggest that HFNC can be used in cases of moderate to severe bronchiolitis upon initial low-flow oxygen failure. HFNC can also reduce intubation and mechanical ventilation in children with respiratory failure. Several observational studies have shown that HFNC can be beneficial in acute asthma and other respiratory distress. Multicenter randomized studies are warranted to determine the feasibility and adherence of HFNC and continuous positive airway pressure in pediatric intensive care units. The development of clinical guidelines for HFNC, including flow settings, indications, and contraindications, device management, efficacy identification, and safety issues are needed, particularly in children.

• Journal of Korean Neurosurgical Society
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• v.65 no.2
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• pp.255-268
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• 2022

Objective : Chronic subdural hematoma (CSDH) is a common disease in neurosurgical departments, but optimal perioperative management guidelines have not yet been established. We aimed to assess the current clinical management and outcomes for CSDH patients and identify prognostic factors for CSDH recurrence. Methods : We enrolled a total of 293 consecutive patients with CSDH who underwent burr hole craniostomy at seven institutions in 2018. Clinical and surgery-related characteristics and surgical outcomes were analyzed. The cohort included 208 men and 85 women. Results : The median patient age was 75 years. Antithrombotic agents were prescribed to 105 patients. History of head trauma was identified in 59% of patients. Two hundred twenty-seven of 293 patients (77.5%) had unilateral hematoma and 46.1% had a homogenous hematoma type. About 70% of patients underwent surgery under general anesthesia, and 74.7% underwent a single burr hole craniostomy surgery. Recurrence requiring surgery was observed in 17 of 293 patients (5.8%), with a median of 32 days to recurrence. The postoperative complication rate was 4.1%. In multivariate analysis, factors associated with CSDH recurrence were separated hematoma type (odds ratio, 3.906; p=0.017) and patient who underwent surgery under general anesthesia had less recurrence (odds ratio, 0.277; p=0.017). Conclusion : This is the first retrospective multicenter generalized cohort pilot study in the Republic of Korea as a first step towards the development of Korean clinical practice guidelines for CSDH. The type of hematoma and anesthesia was associated with CSDH recurrence. Although the detailed surgical method differs depending on the institution, the surgical treatment of CSDH was effective. Further studies may establish appropriate management guidelines to minimize CSDH recurrence.

• Journal of Periodontal and Implant Science
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• v.41 no.3
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• pp.143-148
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• 2011

Purpose: Few epidemiologic studies have investigated aggressive periodontitis in Koreans, but such studies of disease prevalence and other clinical characteristics would be invaluable in providing proper treatment. The aim of this study was to assess the prevalence of aggressive periodontitis and to measure the extent of associated periodontal breakdown. Methods: The study population consisted of 1,692 patients who visited the Department of Periodontology, Wonkwang Daejeon Dental Hospital from January to December, 2010. Clinical parameters (probing depth, gingival recession, periodontal attachment loss) were measured by a single examiner, and radiographic examination was performed at the baseline. Results: Twenty-eight (1.65%) patients showed clinical features of aggressive periodontitis, of which 27 patients exhibited the generalized form, and 1 exhibited the localized form. There was no significant difference between the percentage of male and female patients. The probing pocket depth of the maxillary first molar was deeper than that of the other teeth and gingival recession was also the most serious at the maxillary first molar. The periodontal attachment loss was the highest at the maxillary first molar. The average number of missing teeth was 1.29 per subject. Loss of the second molar was prominent. Conclusions: Within the limitations of this study, the periodontal breakdown evaluated by attachment loss was found to be most severe at the first molars of aggressive periodontitis patients. However, further large scale multicenter studies are necessary to access more precise data, including prevalence.

• Journal of Korean Neurosurgical Society
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• v.47 no.2
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• pp.112-118
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• 2010

Objective : There have been no clinical studies regarding the epidemiology and treatment outcome for unruptured intracranial aneurysm (UIA) in South Korea yet. Thus, The Korean Society of Cerebrovascular Surgery (KSCVS) decided to evaluate the clinical and epidemiological characteristics, and outcome of the treatment of UIA in 2006, using the nationwide multicenter survey in South Korea. Methods : A total of 1,696 cases were enrolled retrospectively over one year at 48 hospitals. The following data were obtained from all patients : age, sex, presence of symptoms, location and size of the aneurysm, treatment modality, presence of risk factors for stroke, and the postoperative 3D-day morbidity and mortality. Results : The demographic data showed female predominance and peak age of seventh and sixth decades. Supraclinoid internal carotid artery was the most common site of aneurysms with a mean size of 5.6 mm. Eight-hundred-forty-six patients (49.9%) were treated with clipping, 824 (48.6%) with coiling, and 26 with combined method. The choice of the treatment modalities was related to hospital (p=0.000), age (p=0.000), presence of symptom (p=0.003), and location of aneurysm (p=0.000). The overall 30-day morbidity and mortality were 7.4% and 0.3%, respectively. The 30-day mortality was 0.4% for clipping and 0.2% for coiling, and morbidity was 8.4% for clipping and 6.3% for coiling. Age (p=0.010), presence of symptoms (p=0.034), size (p=0.000) of aneurysm, and diabetes mellitus (p=0.000) were significant prognostic factors, while treatment modality was not. Conclusion : This first nation-wide multicenter survey on UIAs demonstrates the epidemiological and clinical characteristics, outcome and the prognostic factors of the treatment of UIAs in South Korea. The 30-day postoperative outcome for UIAs seems to be reasonable morbidity and mortality in South Korea.

• Clinical and Experimental Pediatrics
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• v.53 no.12
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• pp.989-993
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• 2010

Although numerous clinical observational studies have been conducted over a period of over 30 years, the clinical significance of $Ureaplasma$ infection is still under debate. The $Ureaplasma$ speices. is a commensal in the female genital tract and considered to have of low virulence; however, $Ureaplasma$ colonization has been associated with infertility, stillbirth, preterm delivery, histologic chorioamnionitis, and neonatal morbidities, including congenital pneumonia, meningitis, bronchopulmonary dysplasia, and perinatal death. Recently, $Ureaplasma$ was subdivided into 2 separate species and 14 serovars. $Ureaplasma$ $parvum$ is known as biovar 1 and contains serovars 1, 3, 6, and 14, and $Ureaplasma$ $urealyticum$ (biovar 2) contains the remaining serovars (2, 4, 5, and 7-13). The existence of differences in pathogenicities of these 14 serovars and 2 biovars is controversial. Although macrolides are the only antimicrobial agents currently available for use in neonatal ureaplasmal infections, in the current clinical field, it is difficult to make decisions regarding which antibiotics should be used. Future investigations involving large, multicenter, randomized, controlled studies are needed before proper recommendations can be made for clinical practice.

• Journal of Hospice and Palliative Care
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• v.24 no.1
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• pp.66-68
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• 2021

The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak to be a pandemic on March 12, 2020. In Korea, there have been 24,027 confirmed cases of COVID-19 and 420 deaths as of October 3, 2020. The clinical spectrum of COVID-19 ranges from asymptomatic infection to death. Cancer care in this pandemic has radically changed. The literature was reviewed. The COVID-19 pandemic has made it urgently necessary to profoundly re-organize cancer patients' care without compromising cancer outcomes. Several important questions in regard to COVID-19 infection in cancer patients have emerged. Are patients with cancer at a higher risk of COVID-19 infection? Are they at an increased risk of mortality and severe illness when infected with COVID-19? Does anticancer treatment affect the course of COVID-19? Based on the existing research, cancer patients with immunosuppression are vulnerable to COVID-19 infection, and cancer patients are more likely to experience severe COVID-19. However, chemotherapy and major surgery do not seem to be predictors of hospitalization or severe disease. Korean background data on patients with cancer and COVID-19 are lacking. Prospective multicenter studies on the outcomes of patients with cancer and COVID-19 should be conducted.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Journal of Gastric Cancer
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• v.12 no.1
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• pp.13-17
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• 2012

Laparoscopic gastrectomy was begun in 1995 in Korea. But, there was 4 years gap to reactivate in 1999. High incidence of gastric cancer and increasing proportion of early cancer through national screening program along with huge effort and enthusiasm of laparoscopic gastric surgeon, and active academic exchange with Japanese doctors contributed development of laparoscopic gastrectomy in Korea. Study group activity of Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) group and Collaborative Action for Gastric Cancer (COACT) group were paramount to evoke large scale multicenter clinical study and various well performed clinical studies. This review encompasses mainly international publications about this area so far in Korea.

• The Journal of Internal Korean Medicine
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• v.42 no.4
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• pp.510-531
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• 2021

Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.