• The Korean Journal of Applied Statistics
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• v.26 no.4
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• pp.581-594
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• 2013

A group sequential design can end a clinical trial early if a confirmed efficacy or a futility of study medication is found during clinical trials. Adaptation can adjust the design of clinical trials based on accumulated data. The key to this methodology is considered to control the overall type 1 error rate while maintaining the integrity of clinical trials. The estimation would be more complex and the sample size calculation will be more difficult if the clinical trials have repeated measurement data. Lee et al. (2002) suggested a repeated observation case by using the independent increments properties of the interim test statistics and investigated the properties of the proposed confidence interval based on the stage-wise ordering. This study extend Lee et al. (2002) to adaptive group sequential design. We suggest test statistics for the adaptation as redesigning the second stage of clinical trials and induce the stage-wise confidence interval of parameter of interests. The simulation will help to confirm the suggested method.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.17 no.6
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• pp.618-628
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• 2016

This study was conducted to identify the influence of clinical practice stress and communication skills on the ego-resilience of nursing students. The subjects were 122 nursing college seniors in B city who have experience in clinical practice. Data were collected from March 23 to 30, 2015, and analyzed by the t-test, ANOVA, Scheffe's test, Pearson's correlation coefficients and multiple regression. It was found that there were significant differences in the ego-resilience depending on the gender, satisfaction with nursing major and relationships among fellow students during clinical practice. There was a significant positive correlation between ego-resilience and communication skills. The meaningful variables which influence the ego-resilience were communication skills, satisfaction with nursing major, relationships among fellow students during clinical practice and gender. These factors were responsible for 38.9% of the total variance in the ego-resilience of the nursing students, and communication skills were the most influential factor. In conclusion, to increase the ego-resilience of nursing students, it is necessary to develop effective communication training programs and strategies to improve their satisfaction with the nursing major and relationships among fellow students during clinical practice.

• Journal of Advanced Technology Convergence
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• v.2 no.2
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• pp.23-30
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• 2023

This study is a descriptive research study conducted to find out the level of perception of the good death among nursing students and compare sub-factors among the perceptions of a good death. As for the research method, 102 people who explained the purpose of the study and agreed to participate were conveniently recruited. As a research tool, 'Measure of concept of a Good Death' by Schwartz et al. (2003) was translated by Lee (2017), and the research was conducted through online. For data analysis, statistical techniques such as descriptive statistics, frequency analysis, t-test, and one-way ANOVA of the IBM SPSS Statistics 26 program were used. Factors showing average differences in scores for each of the three sub-factors of good death awareness were derived from the experience of clinical practice. The mean of good death (3.13±0.36 points) of nursing students who experienced clinical practice was statistically significantly higher than that of students without clinical practice experience (2.90±0.31 points) (t=3.156, p=.002). In particular, the mean of good death for 'closure' was statistically significantly higher for those with experience in clinical practice (3.46±0.39 points) than those without experience (3.16±0.37 points) (t=3.476, p=.001). Through this study, it was confirmed that nursing students' perception of a good death differed depending on whether or not they were in clinical practice. The results of this study are expected to provide basic data for the establishment of effective educational strategies for the perception of good death in nursing students.

• The Korean Journal of Applied Statistics
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• v.33 no.2
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• pp.137-145
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• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• The Korean Journal of Applied Statistics
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• v.23 no.6
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• pp.1115-1124
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• 2010

Normal approximation methods under the null hypothesis of no difference are frequently used to test the two independent proportions in non-inferiority trials. However, these tests are not appropriate under the null hypothesis of non-zero difference. We review the likelihood score methods proposed by Miettinen and Nurminen, Farrington and Manning, and Gart and Nam and compare the performance of these tests. The simulation study shows that the likelihood score tests under the null hypothesis of non-zero difference have better performance at a Type I error and power than usual normal approximation methods.

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.248-254
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• 2010

본 연구에서는 anthracyclines의 심장 독성을 예방하기 위해 사용되는 dexrazoxane의 가장 적절하고 안전한 용량을 평가하고자 했다. 이 약물은 같은 적응증에도 불구하고 미국과 유럽에서 두 배 차이가 나는 용량으로 허가 받아 사용되고 있다. 그러므로 dexrazoxane의 anthracycline로 인한 심독성의 예방에 관한 논문을 찾아 dexrazoxane : doxorubicin = 20:1의 비율로 사용했을 경우와 10:1로 사용했을 때의 효과와 부작용을 비교하였다. 이 두 가지 용량으로 진행된 모든 임상 연구에서 dexrazoxane이 doxorubicin의 심독성 예방에 통계적으로 유효한 효과가 있다고 결론 내렸다. 또한 dexrazoxane의 추가 요법으로 인해 Tumor effect의 차이를 비교 분석한 결과, 두 가지 용량 모두에서 dexrazoxane이 doxorubicin의 항암 효과에 영향을 미치지 않는 것으로 분석되었다. 대부분의 연구에서 dexrazoxane의 약물 자체의 부작용은 분석하지 않았지만, dexrazoxane:doxorubicin을 20:1의 비율로 사용했던 한 연구에서 dexrazoxane군에서 부작용이 있음이 평가되었다. 반면, dexrazoxane의 용량을 doxorubicin 용량에 비해 10:1로 사용한 모든 연구는, 대상 환자군이 18세 이하의 소아 청소년으로 이 용량을 성인에게도 적용할 수 있는지에 대한 추가 연구가 필요하다. 그러나 항암제의 경우, 대부분 환자의 체표면적(BSA)을 기준으로 약용량을 결정하며, 이는 일반적으로 10세 이상이 되면 어른의 체표면적의 70% 정도가 된다. 그러므로, 본 연구에서는 통계적으로 충분한 수의 10세 이상의 소아, 청소년에게 doxorubicin으로 인한 심독성 예방 효과가 입증되었던 dexrazoxane: doxorubicin을 10:1의 용량으로 사용하여도 임상적인 효과를 기대 할 수 있으며, 이 용량은 dexrazoxane 자체의 유해반응도 감소시킬 수 있을 것이라고 결론 맺는다.

• Journal of Korean Ophthalmic Optics Society
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• v.16 no.4
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• pp.363-373
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• 2011

Purpose: To establish basic data for effective management and quality improvement on clinical practice by investigating the clinical practice satisfaction of ophthalmic optics students and optical shop owners. Methods: A survey was administered for 281 students with experience in clinical practices and 105 optical shop owners regarding satisfaction of ophthalmic optics students and optical shops. And a statistical analysis was performed on the survey results. Results: 92.% (97 shops) of optical shop owners responded that clinical practice was necessary and there was a significant difference (p=0.004) according to gender. 4 weeks was the preferred length of practice period (53.3%) and there was a significant difference according to the size of the optical shops (p=0.000). Clinical practice satisfaction of students was 3.50 ${\pm}$ 0.68 and satisfaction for clinical practice program, clinical practice time and clinical practice shop (3.74 ${\pm}$ 0.80) were the highest and there was a significant difference according to the age of the students (p<0.05). Clinical practice satisfaction for optical shops was 4.08 ${\pm}$ 0.64 which is higher than student satisfaction. Satisfaction for clinical practice program was (4.17 ${\pm}$ 0.54) was the highest. Conclusions: To maximize the effects of clinical practice, a clinical practice program reflecting the satisfaction of students and optical shops is required and further research and attention are required.

• The Korean Journal of Applied Statistics
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• v.32 no.1
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• pp.1-13
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• 2019

An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.17 no.4
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• pp.556-566
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• 2016

This study examined the influence of satisfaction with clinical practice and the image of nurses on the nursing professionalism of nursing students. The subjects were 184 nursing students in B city who had experienced clinical practice. The data were collected from November 15 to December 15, 2014 and, analyzed using a t-test, ANOVA, Scheff's test, Pearson's correlation coefficients and multiple regression. Significant differences in the nursing professionalism by gender, religion, age, and school record were observed. Nursing professionalism was positively related to the satisfaction with clinical practice. In addition, there was a positive correlation between the nursing professionalism and image of nurses. Meaningful variables that influenced the nursing professionalism were satisfaction with the contents of clinical practice, image of nurses, satisfaction with the course of clinical practice, satisfaction with the environment of clinical practice, and school record. These factors comprised 75.8% of the total variance in the nursing professionalism of nursing students, and the satisfaction with contents of clinical practice was the most influential factor. In conclusion, to increase the nursing professionalism of nursing students, it is necessary to develop educational programs and institutional strategies to improve the satisfaction with clinical practice and the image of nurses.

• Journal of the Korean Society of Radiology
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• v.16 no.5
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• pp.505-512
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• 2022

In this study, a 3D printed assistive device was applied to X-ray examinations to diagnose human diseases. Based on the results of evaluating the device, statistical and regression analyses were conducted to evaluate its clinical utility and purchase intention, respectively. In the experiment, 90 radiologists performed X-ray examinations on patients who agreed with the use of the assistive device in oblique view X-rays of the lumbar spine, and then statistical analyses were undertaken with a traditional aid and factor analysis. The non-standardized coefficient values of the multiple regression analysis performed by setting the purchase intention of the 3D printed device as the dependent variable and the 3D printed device and traditional aid calculated by factor analysis as independent variables were 0.893 (p<0.001) and 0.269 (p<0.001), indicating statistically significant results. The results show that the 3D printed assistive device proposed in this study has higher clinical utility than traditional aids used in oblique view X-rays of the lumbar spine.