• 대한기관윤리심의기구협의회지
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• 제5권2호
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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.

• 대한불안의학회지
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• 제11권1호
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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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• 제14권1호
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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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• 제13권4호
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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.

• 한국응급구조학회지
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• 제8권1호
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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.

• 대한디지털의료영상학회논문지
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• 제10권2호
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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.

• 대한예방한의학회지
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• 제28권1호
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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.

• 한국방사선학회논문지
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• 제12권1호
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• pp.53-64
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• 2018

AUDIT-K(한국형 알코올 중독 간이선별 검사법)을 이용하여 일상적으로 생활하고 있는 상당수의 잠재적인 위험 음주자들을 선별 할 수 있었으며 연령, 종교, 결혼여부, 직업, 소득음주사망 가족력, 음주시작 연령, 흡연, BMI(체질량지수)는 통계적으로 유의한 차이가 없었으며, 학력, 음주기간만 통계적으로 유의하였다. 이러한 결과는 교육을 더 받은 사람의 남성이 알코올 소비가 더 높다고 한 선행연구와 부합하는 결과를 나타내었으며 교육수준 또한 무엇을 어떻게 배웠는가에 따른 차이를 살펴 볼 필요가 있음을 시사하며, 교육에 따른 알코올 소비도 각각 다른 결과를 나타냄을 알 수 있다. 또한 나이가 적을수록 술을 많이 마시면 음주기간이 길어질 것이고 기존의 음주시작 연령에 대한 연구와 일치하는 결과가 나타났다. 본 연구에서는 음주 기간이 알코올 사용 장애의 가장 큰 요인이었으며 음주 기간을 단축하기 위한 방법으로는 음주 시작 연령을 최대한 늦출 수 있는 국가 정부 제도의 대책 및 교육이 필요하다고 생각된다.

• Asian Pacific Journal of Cancer Prevention
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• 제13권4호
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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.

• 대한수혈학회지
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• 제23권2호
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• pp.136-144
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• 2012

배경: 신선동결혈장은 응고인자의 보충을 위한 치료적 투여를 주된 목적으로 하지만, 실제로 적응증이 아닌 경우에도 부적절하게 사용되는 경우가 종종 있다. 방법: 년 2010년 7월부터 2011년 6월까지 1년간 세브란스병원 혈액은행에서 출고된 신선동결혈장의 적정 사용에 대한 평가를 시행하였다. 평가기준은 2009년 대한수혈학회에서 발간한 수혈가이드라인과 세브란스병원의 수혈적정성 평가 전산시스템에 기초하였다. 결과: 신선동결혈장은 1년 간 총 1,949명에게 4,982회에 걸쳐 17,733단위가 출고되었고, 이 중 1,990회(총 건수의 39.9%)가 부적절 수혈로 평가되었다. 진료과별 사용 건수는 소화기내과 등의 내과 계열이 흉부외과나 일반외과 등의 외과 계열보다 많았다. 그러나 부적절 사용 비율은 외과 계열이 내과 계열보다 높았다. 질병분류별 사용건수와 이들의 부적절 사용 비율은 유사한 양상을 보였는데, 종양, 소화 계통의 질병, 순환 계통의 질병군이 높은 사용 건수와 부적절 사용 비율을 보였다. 결론: 수혈의 적정성 유지를 위해서는 각 의료기관에서 수혈 적정성이 항상 평가되고, 그 결과를 임상의사들에게 정기적으로 피드백하는 과정이 중요하며, 이와 더불어 신선동결혈장 수혈 적응증에 대한 새로운 고찰이 필요할 것으로 사료된다.