• The Journal of KAIRB
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• v.5 no.2
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• pp.51-58
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• 2023

Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ²-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

• Anxiety and mood
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• v.11 no.1
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• pp.54-60
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• 2015

Objective : To translate Center for Epidemiologic Studies Depression Scale (CES-D) into North Korean language and to examine its reliability and validity Methods : North Korean defectors (n=207) recruited from the call center for North Korean defectors participated. Psychiatrists and psychiatric residents interviewed the participants and made the psychiatric diagnoses. Subsequently, the participants completed the CES-D, Impact of Event-Scale-Revised-North Korea (IES-R-NK), Alcohol Use Disorders Identification Test-North Korea (AUDIT-NK), and Brief Psychological State Inventory for North Korean Refugees (BPSI-NKR) questionnaires. Of the original participants, 143 subjects participated in test-retest reliability study after one week. Results : Cronbach's alpha coefficient of CES-D-NK was superior in both males (0.91) and females (0.93). The test-retest correlation coefficient was high (males, 0.64 ; femals, 0.79). Good convergent validity was evident by significant correlations with IER-R-NK, BPSI-NKR-Depression and BPSI-NKR-PTSD, respectively. CES-D-NK had no or weak correlations with AUDIT-NK and BPSI-NKR-Alcohol, showing its discriminant validity. Conclusion : CES-D-NK could be a reliable and valid tool for screening and assessing depressive symptoms of North Korean defectors.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.1
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• pp.547-552
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• 2013

To investigate patient, cancer and treatment characteristics in females with breast cancer from more remote areas of Australia, to better understand reasons for their poorer outcomes, bi-variable and multivariable analyses were undertaken using the National Breast Cancer Audit database of the Society of Breast Surgeons of Australia and New Zealand. Results indicated that patients from more remote areas were more likely to be of lower socio-economic status and be treated in earlier diagnostic epochs and at inner regional and remote rather than major city centres. They were also more likely to be treated by low case load surgeons, although this finding was only of marginal statistical significance in multivariable analysis (p=0.074). Patients from more remote areas were less likely than those from major cities to be treated by breast conserving surgery, as opposed to mastectomy, and less likely to have adjuvant radiotherapy when having breast conserving surgery. They had a higher rate of adjuvant chemotherapy. Further monitoring will be important to determine whether breast conserving surgery and adjuvant radiotherapy utilization increase in rural patients following the introduction of regional cancer centres recently funded to improve service access in these areas.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.4
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• pp.1675-1682
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• 2012

Aim: The study aim was to determine the frequency with which women decline clinicians' treatment recommendations and variations in this frequency by age, cancer and service descriptors. Design: The study included 36,775 women diagnosed with early invasive breast cancer in 1998-2005 and attending Australian and New Zealand breast surgeons. Rate ratios for declining treatment were examined by descriptor, using bilateral and multiple logistic regression analyses. Proportional hazards regression was used in exploratory analyses of associations with breast cancer death. Results: 3.4% of women declined a recommended treatment of some type, ranging from 2.6% for women under 40 years to 5.8% for those aged 80 years or more, and with parallel increases by age presenting for declining radiotherapy (p<0.001) and axillary surgery (p=0.006). Multiple regression confirmed that common predictors of declining various treatments included low surgeon case load, treatment outside major city centres, and older age. Histological features suggesting a favourable prognosis were often predictive of declining various treatments, although reverse findings also applied with women with positive nodal status being more likely to decline a mastectomy and those with larger tumours more likely to decline chemotherapy. While survival analyses lacked statistical power due to small numbers, higher risks of breast cancer death were suggested, after adjusting for age and conventional clinical risk factors, (1) for women not receiving breast surgery for unstated reasons (RR=2.29; p<0.001); and (2) although not approaching statistical significance $p{\geq}0.200$), for women declining radiotherapy (RR=1.22), a systemic therapy (RR1.11), and more specifically, chemotherapy (RR=1.41). Conclusions: Women have the right to choose their treatments but reasons for declining recommendations require further study to ensure that choices are well informed and clinical outcomes are optimized.

• The Korean Journal of Emergency Medical Services
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• v.8 no.1
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• pp.57-70
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• 2004

This is an exploratory study to describe drinking patterns and problem drinking and alcohol-related problem in college students. The major purpose of this study is to describe the prevalence of drinking styles, the quantity of alcohol getting drunken and the describe the frequency of drunkenness in the previous 12months prior to the survey, and to examine the patterns of how various drinking behaviors are different by drinking style. We used the scale for measuring problem drinking NAST(1), AUDIT, indicated that males drank more and more and more frequently, and had episodes of drunkenness and more accepting of drinking than females, the amount of alcohol becoming intoxicated, the frequency and quantity of alcohol consumed in the month, and the frequency of intoxicated were significantly different by drinking styles in both sexes. A problem drinking rate, danger drinker 49.3% dependence drinker 3.5% in ADULT and alcohol dependency 9.7% in NAST(1) It will be necessary to discuss about adequate policy and eucation protrams to be able to curb collegiate's alcohol abuse.

• Korean Journal of Digital Imaging in Medicine
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• v.10 no.2
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• pp.17-22
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• 2008

It is to improve customer satisfaction measurement and CT Scan process without delay of examination time when is using Scan positioning time(Planning time) that time is happened always between research reactor CT examination to increase fear and examination satisfaction by the customer's comprehension tribe which get the latest contrast enhancement CT examination. Needs and interests that customer wants to compose visual and auditory Contents to be played to Scan positioning time did questionnaire about curiosity later before CT examination to 600 people for October - November 2 months of 2006 to customer whole that get CT examination on source. Data getting through questionnaire investigated examination comprehension and satisfaction through questionnaire after experiment Scan Positioning to 500 coming to help customers to be source CT examination for 3 months February December - 2007 year in 2006 manufacturing Voice and Visual announce media for reference. To customer who interest degree appeared, and answers preparatory audit from preparatory audit about curiosity of CT examination customer to order of examination time required(43%), contrast media side effect(26%), examination region(20%), breath(10%), etc..(1.5%) audio-visual materials in questionnaire that attain after do reclamation among examination age, sex, reception type of irrelatively in 91% of target increase of hailing degree and examination satisfaction appear. Searched that customer hailing and satisfaction are increased greatly when use of audio-visual materials in satisfaction result that use CT Positioning delay time. In experiment process, It took lacking part by method that use hearing in case of do not use sight as is unavoidable in subject position or old age. Through this, audio-visual materials could analogize that it is more useful method that use sight and hearing at the same time.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of the Korean Society of Radiology
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• v.12 no.1
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• pp.53-64
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• 2018

Using the AUDIT-K (Korean versions of alcohol use disorders identification test), it was able to select a large number of potential danger drinkers who routinely live. There were no statistically significant differences in age, religion, marital status, occupation, family history of alcohol drinking, age at onset of alcohol use, smoking, and BMI (body mass index). However, only education and drinking periods were statistically significant. These results are consistent with the previous study, which suggests that alcohol consumption is higher among men who are educated. The level of education also suggests that there is a need to look at the differences depending on what you learned and how. Alcohol consumption by education also shows different results. Also, drinking at a young age will lead to a longer drinking period, which is consistent with previous studies on the age at onset of drinking. In this study, drinking period was the most important factor of alcohol use disorder and it is considered that measures and education of national government system which can delay drinking age as much as possible is needed as a method to shorten drinking period.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.4
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• pp.1413-1418
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• 2012

Background: Previous studies generally indicate that synchronous bilateral breast cancers (SBBC) have an equivalent or moderately poorer survival compared with unilateral cases. The prognostic characteristics of SBBC would be relevant when planning adjuvant therapies and follow-up medical surveillance. The frequency of SBBC among early breast cancers in clinical settings in Australia and New Zealand was investigated, plus their prognostic significance, using the Breast Cancer Audit Database of the Society of Breast Surgeons of Australia and New Zealand, which covered an estimated 60% of early invasive lesions in those countries. Design: Rate ratios (95% confidence limits) of SBBC were investigated among 35,370 female breast cancer cases by age of woman, histology type, grade, tumour diameter, nodal status, lymphatic/vascular invasion and oestrogen receptor status. Univariate and multivariable disease-specific survival analyses were undertaken. Results: 2.3% of cases were found to be SBBC (i.e., diagnoses occurring within 3 months). The figure increased from 1.4% in women less than 40 years to 4.1% in those aged 80 years or more. Disease-specific survivals did not vary by SBBC status (p=0.206). After adjusting for age, histology type, diameter, grade, nodal status, lymphatic/vascular invasion, and oestrogen receptor status, the relative risk of breast cancer death for SBBC was 1.17 (95% CL: 0.91, 1.51). After adjusting for favourable prognostic factors more common in SBBC cases (i.e., histology type, grade, lymphatic/vascular invasion, and oestrogen receptor status), the relative risk of breast cancer death for SBBC was 1.42 (95% CL: 1.10, 1.82). After adjusting for unfavourable prognostic factors more common in SBBC cases (i.e., older age and large tumour diameter), the relative risk of breast cancer death for SBBC was 0.98 (95% CL: 0.76, 1.26). Conclusions: Results confirm previous findings of an equivalent or moderately poorer survival for SBBC but indicate that SBBC status is likely to be an important prognostic indicator for some cases.

• The Korean Journal of Blood Transfusion
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• v.23 no.2
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• pp.136-144
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• 2012

Background: Fresh frozen plasma (FFP) transfusion is administered primarily for management of acquired bleeding disorders. However, in practice, FFP transfusion is increasing without a solid rationale. Methods: We conducted an audit to evaluate the appropriateness of the indications for FFP transfusion during the period from July 2010 through June 2011. Assessment of the appropriateness of the indications was based on the national transfusion guidelines and the transfusion criteria promulgated by the Severance Hospital. Results: In total, 17,733 units of plasma were transfused to 1,949 patients over 4,982 events. We found that administration of FFP was not in compliance with the recommended guidelines in 1,990 events. The number of total FFP transfusions was higher in medical departments (Gastroenterology) than in surgical departments (Thoracic and cardiovascular surgery, General surgery). However, the proportion of cases of inappropriate transfusion was higher in surgical departments than in medical departments. Both the total number of FFP transfusion and the proportion of inappropriate transfusion were high in patient with neoplasm, disease of the digestive system, and diseases of the circulatory system. Conclusion: Continuous monitoring on appropriateness for FFP transfusion and feedback to the physician are critical in securing the transfusion safety as well as maintaining the quality of FFP transfusion. New-found indication for FFP transfusion should be investigated and applied in timely manner.