• The Journal of KAIRB
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• v.6 no.2
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• pp.38-47
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• 2024

Purpose: The purpose of this study is to compare the efficiency of 2 types of Institutional Review Boards (IRBs) for multicenter research. Methods: The 2 types are joint IRB and local IRB. For this study, we selected multicenter research reviewed and approved by joint or local IRBs between October 2019 and December 2022. We assessed the time it took for each IRB to approve the research based on the number of working days per IRB review case. We then stratified the data according to the number of participating institutions, the type of research, and the type of IRB review. Results: The results of our study show that joint IRB is more efficient than local IRB. The median IRB approval time for joint IRB was 27 days, 73.5% shorter than local IRB (27 days vs. 102 days, respectively, p<0.001). As the number of participating institutions in multicenter research increased, joint IRB reviews became more efficient regarding the required approval time than local IRB reviews. We also found that joint IRB was faster in every administrative step until new research was approved (p<0.005) when compared to local IRB. Conclusion: Our study highlights that a single review through a joint IRB can significantly reduce the time required for IRB approval of multicenter research. This approach can ensure that all participating institutions follow the same review results. Therefore, a single IRB review effectively reduces the burden of IRB for multicenter research.

• The Journal of Internal Korean Medicine
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• v.45 no.1
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• pp.1-10
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• 2024

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

• The Journal of Internal Korean Medicine
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• v.30 no.4
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• pp.696-707
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• 2009

Objective : We designed this study to investigate differences between stroke reattack and stroke first attack group to establish fundamental data and prevent a secondary stroke. Methods : 826 subjects were recruited from the patients admitted to the department of internal medicine at Kyung Hee University Oriental Medical Center, Kyung Hee University East-West Neo Medical Center, Kyungwon University Incheon Oriental Medical Center, Kyungwon University Songpa Oriental Medical Center and Dongguk University Ilsan Oriental Medical Center from 1 April 2007 to 31 August 2009. We compared general characteristics, classification of diagnosis, subtypes of cerebral infarction, risk factors, Sasang constitution, diagnostic classifications between stroke reattck and stroke first attack groups. Results : 1. In general characteristics, age differed significantly between the reattck and first attack groups. 2. Classification of diagnosis differed significantly between reattck and first attack groups. 3. In risk factors, hypertension, diabetes mellitus, alcohol drinking, and stress were significantly different between reattck and first attack groups. 4. Diagnostic classifications were significantly different between reattck and first attack groups. Conclusion : To prevent recurrence of stroke, education on stroke risk factors associated with recurrence is needed. In addition, those who are diagnosed as Dampness-Phlegm need to be well-controlled.

• Radiation Oncology Journal
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• v.24 no.4
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• pp.263-271
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• 2006

$\underline{Purpose}$: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. $\underline{Materials\;and\;Methods}$: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. $\underline{Results}$: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. $\underline{Conclusion}$: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.

• Journal of Gastric Cancer
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• v.5 no.3 s.19
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• pp.139-145
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• 2005

Gastric cancer is the most prevalent cancer in Korea and comprises the second cause of cancer death. Surgery only can provide chance of cure, but most locally advanced cancers recur after a curative resection, even though important advances in the surgical and nonsurgical treatments of gastric cancer have taken place. Preoperative chemotherapy theoretically can provide the advantages of reducing the bulk of tumor, which might improve the R0 resection rate, and of treating micrometastases early. Also, preoperative chemotherapy is expected to render unresectable tumors resectable without increasing postoperative morbidity and mortality. There are many new chemo-therapeutic agents available for the treatment of advanced gastric cancer, but still the most effective agent, the optimal time and number of cycle for administration are still not known. The addition of postoperative chemotherapy through an intraperitoneal route and/or radiotherapy might affect the outcome of surgery favorably, but that hasn't been proved yet. A multicenter prospective randomized phase III trial should be peformed to answer for those questions and to improve the curability of gastric cancer treatment.

• Journal of Sasang Constitutional Medicine
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• v.19 no.3
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• pp.144-155
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• 2007

1. Objectives The purpose of this study was to find the difference of ordinary and pathological symptoms according to Sasang Constitution. 2. Methods We recruited 418 subjects in the five oriental hospitals and researched normal symptoms and illness ones through a paper, who were diagnosed by the Sasang Constitution specialist in oriental hospital, who had remarkable improvement in their chief complain after Sasang Constitution medication. 3. Results 1) In ordinary symptoms, amount, speed and appetite items of Digestion are significantly different according to Sasang Constitution statistically(p<0.05). Feeling after evacuation of Feces, feeling after urination and yellow color of Urine, amount, feeling after sweat, location in hand/feet of Sweat, and in the others, Tireness in head, Drinking water, sensitivity, coldness in hand/feet, warmness in belly of Coldness/Warmness are also significantly different(p<0.05). 2) In pathological symptoms, palpitation, swelling and lack of appetite items are significantly different according to Sasang Constitution statistically(p<0.05). 3) In diseases, Hypertension and DM items are significantly different according to Sasang Constitution statistically(p<0.05). 4. Conclusions There were significantly difference items in ordinary, pathological symptoms and diseases according to Sasang Constitution.

• Journal of The Korean Society of Clinical Toxicology
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• v.5 no.1
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• pp.36-42
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• 2007

Purpose: To assess the epidemiology and the clinical features of Glufosinate herbicide in Korea. Methods: Data was prospectively collected during 1 year since August 2005 from 38 hospital in Korea. We analyzed the epidemiologic characters and clinical manifestations of Glufosinate poisoning. In addition, the characteristics of patients with severe central nervous system toxicity were separately analyzed to find poor prognosis relating factors. Results: During study periods, there were 715 persons of poisoning of herbicides and insecticides. 6.3% (45 persons) of the agricultural chemicals poisoning had Glufosinate poisoning. There were 36 cases of suicide attempts and 7 cases of accidental exposure, The major of poisoning route was oral ingestion (44 cases). 28.9 % of the study patients had not toxic symptoms. The most common symptoms were gastrointestinal symptoms relating surfactant irritation. 67.7% of central nervous symptoms occurred lately. 10 persons showed severe central nervous system toxicity. 4 persons of them showed poor outcomes (1 death, 3 hopeless discharged). Complications of respiratory failure and renal failure related with poor outcome. Conclusion: Majority of patients ingested Glufosinate for suicide attempt. 22.2% of patients with Glufosinate poisoning showed delayed serious central nervous system toxicity. Early supportive care of altered mentality may prevent late respiratory complications and improve the outcomes.

• Childhood Kidney Diseases
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• v.7 no.2
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• pp.189-196
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• 2003

Purpose : Ureteral duplication is a common urologic anomaly and early diagnosis may prevent irreversible renal damage. We thus aimed to evaluate the benefits of prenatal sonography in early detection. Methods : We retrospectively studied 55 children with duplicated systems who were admitted to Severance Hospital, Yonsei University, Seoul, Korea from January 1998 to July 2003. Results : The mean age at diagnosis was 2.3 years old. 89% of the children had complete duplicated ureter. 47% of the children visited the hospital with an initial complaint of abnormal prenatal sonographic findings. Among these patients, 70.8% had DMSA defects. The mean differential renal function(DRF) in the DMSA scan was 48.2% in the group diagnosed prenatally. In the postnatally-diagnosed group, DMSA defects were found in 67.7% patients and the mean DRF was 45.5%. Conclusion : In comparison with the past studies, the mean age at diagnosis is becoming younger, and the proportion of abnormal prenatal sonography as an initial complaint larger. Other clinical manifestations were similar. The difference of the renal damage between the prenatally diagnosed group and the postnatally diagnosed group was not statistically significant. A multi-center study may help to prove the importance of prenatal sonography in early diagnosis and treatment of ureteral duplication. (J Korean Soc Pediatr Nephrol 2003;7:189-196)

• Neonatal Medicine
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• v.18 no.2
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• pp.293-300
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• 2011

Purpose: The aim of the study was to investigate the change in usage and clinical outcomes of using a humidified high flow nasal cannula (HHFNC) in preterm infants. Methods: A retrospective review of patients with gestational age <32 weeks born at our neonatal intensive care unit from January 2008 to March 2011 was performed. First, data were compared between Era 1 (January 2008 to February 2009) and Era 2 (March 2009 to March 2011) to describe the increased usage of HHFNC. Second, the patients (gestational age 25-30 weeks) were divided into two groups to compare clinical outcomes. nasal continuous positive airway pressure (NCPAP) and HHFNC groups who received either NCPAP or HHFNC as a respiratory support within 14 days of birth. Results: Compared to Era 1, HHFNC usage increased from 10 to 55% in Era 2, whereas NCPAP usage decreased from 40 to 5%. No difference in pulmonary or adverse outcomes including the incidence of reintubation and bronchopulmonary dysplasia (BPD), days on oxygen and a ventilator, and other outcomes was observed between the HHFNC and NCPAP groups. Days to reach full feed (32.2${\pm}$16.7 vs. 24.7${\pm}$10.2, P=0.05) and regain birth weight (20.9${\pm}$16.9 vs. 17.2${\pm}$4.3, P=0.04) decreased in the HHFNC group. Conclusion: HHFNC was feasible and did not differ in respiratory and other outcomes, but days to reach full feed and regain birth weight decreased in the HHFNC, when compared with the NCPAP. An additional prospective multicenter designed study is needed to better define safety and efficacy of HHFNC.

• Anxiety and mood
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• v.10 no.1
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• pp.11-16
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• 2014

Objective : Despite the high prevalence and clinical importance of panic disorder, studies on the clinical characteristics and course of panic disorder are relatively rare. This study is a multi-center, and retrospective study to examine the clinical characteristics and course of Korean panic disorder patients who visit university hospital. Methods : The study subjects were panic disorder patients who had visited the psychiatric outpatient clinics of 8 university hospitals in South Korea from January to December in 2008. Finally, 238 panic patients were included in this study. Their medical charts were retrospectively reviewed and reassessed by experienced psychiatrists to examine their clinical characteristics, demographic data and clinical course in repose to pharmacotherapy. Results : Among the 238 patients (121 males vs. 117 females), the mean age of disease onset was $41.3{\pm}12.7$ years and female patients showed 5 years older age of disease onset, compared with male patients. The mean score of PSR scale was $4.5{\pm}1.0$ at the first visit, reflecting a 'marked' level of severity of illness and impairment in functioning. Only 110 patients (46.4%) completed the whole follow up visits, whereas 128 patients (53.6%) dropped out during the treatment. After $17.7{\pm}0.5$ months of mean follow up period, the mean score of PSR scale at the last visit was reduced into $2.1{\pm}0.9$, reflecting a 'residual' severity of illness and impairment in functioning. The cumulative recovery rate was 62.1% in the completer group, whereas that of the drop-out group was 47.7%. Conclusions : The mean age of disease onset in Korean panic disorder patients who had visited university hospital was about 10 years older than that of Western panic disorder patients in previous studies, and the Korean panic disorder patients who had visited university hospital showed a relatively higher cumulative recovery rate. These differences might result from an ethnic difference in clinical characteristics and course in response to pharmacotherapy of panic disorder.