• The Journal of KAIRB
• /
• v.3 no.2
• /
• pp.19-27
• /
• 2021

Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

• The Journal of KAIRB
• /
• v.6 no.1
• /
• pp.5-16
• /
• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

• Journal of Sleep Medicine
• /
• v.15 no.2
• /
• pp.37-42
• /
• 2018

Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

• Journal of Korean Clinical Nursing Research
• /
• v.17 no.3
• /
• pp.421-432
• /
• 2011

Purpose: The purpose of this study was to investigate the sleep patterns and the factors related to sleep disturbance in mechanically ventilated patients in intensive care units (ICUs). Sleep patterns in this study included both quality and quantity of sleep. Methods: Forty-four subjects were recruited in ICUs at a tertiary university hospital in D city. Data were collected using questionnaires, observation, and medical record from June, 2008 to May, 2009. Results: The total mean of sleep quality was $1.99{\pm}1.68$. The mean of total sleep time per 24-hour period was $3.75{\pm}1.94$hour (range 1-7.25) in mechanically ventilated ICU patients. The main sleep disturbance factors were listed as frequent nursing activities, attachment of medical appliances, and noise. All these factors were also significantly related to the sleep quality. Conclusion: These results indicated that mechanically ventilated patients were both qualitatively and quantitatively deprived of sleep far more than other ICU patients. In summary, a deeper understanding of sleep characteristics in mechanically ventilated ICU patients could help nurses to improve sleep derangements and patient outcome.

• Journal of Korean Clinical Nursing Research
• /
• v.16 no.3
• /
• pp.39-50
• /
• 2010

Purpose: The study was done to examine the development and effects of horticulture therapy on quality of sleep and immune function in patients in hospice units. Methods: The participants in this study were hospice patients in D hospital in D city. Thirty hospice patients were assigned to the experimental group, thirty to the control group. Data were collected from April 29 to July 26, 2009. The horticulture therapy program consisted of indoor and outdoor horticultural activities. The horticulture therapy was conducted for 30 minutes, 6 times a week for 3 weeks (a total 18 times). Measures were quality of sleep, and immune function by serum T-cell, NK-cell count. Data were analyzed using descriptive statistics, chi-square test and t-test with SPSS/WIN 13.0 version. Results: Patients in the experimental group receiving horticulture therapy had a significant difference in changes in the quality of sleep compared to the control group. There were also a significant difference in changes in the immune function (serum T cell and serum NK cell) between the experimental group and control group. Conclusion: The study results indicate that horticulture therapy developed for hospice patients is an effective, palliative intervention program to improve the quality of sleep and immune function of hospice patients.

• Journal of Korean Clinical Nursing Research
• /
• v.15 no.1
• /
• pp.123-132
• /
• 2009

Purpose: This study was conducted to identify the effects of provision of a cancer pain guideline and education for patients with cancer and their families on their knowledge and attitude toward cancer pain control. Method: A nonequivalent control group pre-post test design was used. The participants were selected according to a selection criteria from patients and their families on the medical ward at K university hospital in D city. Both the experimental group for patients with cancer and control group consisted of 16 patients and their families. Results: The first hypothesis, which assumed that there was a difference between the patients in the experimental group and the control group on knowledge (t=-20.006, p=.000) and attitude (t=-13.492, p=.000), was accepted. The second hypothesis, which assumed there was a difference between families in the experimental group and the control group on knowledge (t=-16.087, p=.000) and attitude (t=-10.262, p=.000), was supported. Conclusion: Education for cancer related pain control with a patient guideline had a positive effect on knowledge and attitude of patients with cancer patients and their families suggesting that there is a need to developed this type of guidelines.

• Health Communication
• /
• v.13 no.2
• /
• pp.217-221
• /
• 2018

Background: There are practical difficulties to show exact clinical symptoms such as seizure to medical students at Clinical Performance Examination (CPX). We developed a new CPX case of child's seizure on video using smartphone. Methods: A total of 356 $4^{th}-year$ students of five universities in Daegue-Gyeongbuk and Gyeongnam area took the clinical skill examination from June $13^{th}$ to $17^{th}$ in 2016. Among them, 72 students took the new CPX case in June $15^{th}$ and 71 students filled out the questionnaire on whether the new CPX with smartphone video is helpful, authentic, difficult, and necessary for other CPX. All the questions were measured on 5-Likert scale. Results: Mean score of the new CPX was 57.1, lower than the mean scores of the other 11 CPX cases, 62.8. For the question "Smartphone videos helped to solve the problem", 45 students (63.4%) answered 'Very much'. For the question "Is it realistic compared to other questions?" 30 students (42.3%) and 25 students (35.2%) answered 'Very much' and 'Much'. For the question "Is it difficult compared with other questions?" 18 students (25.4%) and 26 students (36.6%) answered 'Very much' and 'Much'. As for the question "I would like to have more tests using smartphone video", 26 students (36.6%) answered 'So and so'. Conclusion: A majority of students responded that video presentation was helpful and authentic to figure out the CPX, whereas they assessed smartphone video was more difficult compared with other CPXs. Further, students were negative toward using smartphone video for the other CPXs.

• Clinical and Experimental Pediatrics
• /
• v.46 no.6
• /
• pp.572-575
• /
• 2003

Purpose : This study was performed to analyze the endoscopic findings in Henoch-Schonlein purpura patients, and to compare the differences in endoscopic findings according to age and gastrointestinal symptoms. Methods : We examined children with Henoch-Schonlein purpura aged 3 to 15 years between September 1996 and October 2002. The total number studied was 65, consisting of 41 boys and 24 girls. Endoscopy was performed and the results were analysed. Results : Among 65 cases, 12 cases of duodenitis, nine cases of gastritis and duodenitis, six cases of duodenal erosion, five cases of gastritis, five cases of duodenal ulcer, two cases of gastric ulcer and one case of colonic erosion were noted. Endoscopic abnormality was found in 38 of 53 who had gastrointestinal symptoms, and in two of 12 who didn't have gastrointestinal symptoms. Conclusion : Most of the gastrointestinal symptoms in Henoch-Schonlein purpura patients were relieved without complication. But in some cases severe symptoms such as hematemesis, melena, and abdominal pain localized to epigastric area were developed when diagnosis was delayed. Prompt endoscopy will be helpful for diagnosis and therapy of Henoch-Schonlein purpura with gastrointestinal involvement.

• Clinical and Experimental Pediatrics
• /
• v.46 no.11
• /
• pp.1112-1117
• /
• 2003

Purpose : Recent advances in the methods of treating cancer in young patients have led to both an increased frequency of CNS complications as well as prolonged life expectancy. We intend to analyze the clinical aspects and laboratory findings of patients with CNS complications during and after treatment. Methods : We reviewed the medical records of 174 childhood cancer patients treated with chemotherapy admitted to the Dept. of Pediatrics, Keimyung University Dongsan Hospital, from January 1995 to November 2002. Among them, 15 cases with CNS complications were investigated in this study. Results : CNS abnormalities were found in 13 patients by CT or MRI during treatment such as leukoencephalopathy(n=7), mineralizing microangiopathy(n=4), brain infarction(n=3), intracranial hemorrhage(n=1), and hypoxic ischemic encephalopathy(n=1). It was found that two patients had two or more CNS abnormalities. Two patients who had no imaging abnormalities had convulsions, possibly after the addition of intrathecal methotrexate. The patients with intracranial hemorrhage and brain infarction had rapid and fatal clinical courses. The hypoxic ischemic encephalopathy following electrolyte imbalance completely recovered after correction of electrolyte. Conclusion : The CNS complications that occur during and after chemotherapy influence prognoses significantly, and remain neurologic sequelae. Therefore early diagnosis and prophylaxis for CNS complications and regular physical examination of patients who have recieved cancer therapy are strongly recommended.

• Clinical and Experimental Pediatrics
• /
• v.46 no.11
• /
• pp.1107-1111
• /
• 2003

Purpose : Neuroblastoma is a malignant neoplasm which arises from primitive sympathetic neuroblasts, and occasionally can matured from a malignant neuroblastoma into a benign ganglioneuroma. It has the highest rate of spontaneous regression of any pediatric tumor. We performed a retrospective study of pathologic features after combination therapy in advanced neuroblastoma. Prognostic effects of the individual morphologic feature and prognostic groupings according to modified Shimada classification systems were analyzed. Methods : The treatment results for six patients with neuroblastoma seen at Keimyung University from Jan. 1991 to June 2000 were analyzed. Patients were treated with a combination of chemotherapy, radiation therapy, and surgery, and classified by two major prognostic criteria based on morphological features of neuroblastoma, such as modified Shimada classification and histologic grading. Results : Three cases were classified to a good histologic group; among them, two cases survived, but one case was lost in follow-up. There were three cases classified in a poor histologic group. All of these patients expired due to sepsis and hemorrhagic pancreatitis. Conclusion : Prognostic classification due to pathologic findings had significant value in evaluating the survival rate of neuroblastoma patients.