• Title/Summary/Keyword: 임상통계

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The Necessity of Independent Data Monitoring Committee in Domestic Clinical Trials (현재 국내임상시험에서 독립적 자료모니터링위원회의 필요성)

  • Kang, Seung-Ho
    • The Korean Journal of Applied Statistics
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    • v.22 no.2
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    • pp.317-327
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    • 2009
  • In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if not, it may cause bias. The international guidelines recommend the establishment of independent data monitoring committee for conducting interim analysis independently.

A Study on the Satisfaction with Clinical Practice of Occupational Therapy Students (작업치료(학)과 학생들의 임상실습 만족도)

  • Young, Mi-Hyun
    • Journal of Korea Entertainment Industry Association
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    • v.13 no.1
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    • pp.167-173
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    • 2019
  • It is reported that the higher the satisfaction of students' clinical practice, the more the ability to perform their work. It is important to assess student satisfaction with clinical practice. This study is to investigate the satisfaction of occupational therapy students' clinical practice. The research data will be used as basic data for effective clinical practice. The subjects of this study were 319 occupational therapy students who completed clinical training. The data collection period was from August 1, 2017 to August 13, 2017. The questionnaire used in the previous literature was used to measure the satisfaction of clinical practice. The collected data were statistically processed using the SPSS 12.0 statistical program. The general characteristics of the study subjects were more female, university more. Satisfaction with major was the most satisfied and the training period was the most 24 weeks. Rehabilitation hospitals were the highest in the training institutions. The results showed that the satisfaction of clinical practice was higher in the order of clinical practice, satisfaction after clinical practice, clinical practice environment, teaching method of clinical practice, clinical practice time, evaluation of clinical practice, and internal conflicts in clinical practice. Clinical practice satisfaction according to general characteristics was significantly different according to the major satisfaction and the training period.

The Mediating Effect of the Resilience on the Relationship between Stress in Clinical Practice and Clinical Competence in Nursing Students (간호대학생의 임상실습스트레스와 임상수행능력의 관계에 미치는 극복력의 매개효과)

  • Kim, Ju-Yeun;Kim, Min-Kyeong;Cho, Jin Young
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.18 no.1
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    • pp.669-678
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    • 2017
  • This study aimed to identify the mediating effect of resilience on the relationship between stress during clinical practices and clinical competence in nursing students. A total of 137 senior nursing students in three different universities located in C city were included. The study period was between October 15 and November 15, 2016, and the data were collected using by structured questionnaires. Collected data were analyzed by descriptive analysis, t-test, ANOVA, Pearson's correlation, and Multiple regression using the SPSS 22.0 statistical program. The average score of stress in clinical practice, clinical competence, and resilience were $3.09{\pm}0.43$, $3.54{\pm}0.45$ of 5 and $4.93{\pm}0.66$ of 7. There were significantly negative correlations between stress in clinical practice and resilience (r=-.24, p=.005), as well as stress in clinical practice and clinical competencies (r=-.21, p=.012), while there were significantly positive correlations between resilience and clinical competencies (r=.59, p<.001). Resilience had a full mediated effect between stress in clinical practices and clinical competencies, which showed the significance upon Sobel test (Z=-3.02, p=.003). Therefore, it is suggested that various training courses and programs for strengthening resilience should be developed and applied to nursing curriculum.

Maximum Tolerated Dose Estimation by Stopping Rule and SM3 Design in a Phase I Clinical Trial (제 1상 임상시험에서 멈춤 규칙과 SM3 디자인을 이용한 최대허용용량 추정법)

  • Kim, Byoungchan;Kim, Dongjae
    • The Korean Journal of Applied Statistics
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    • v.27 no.1
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    • pp.13-20
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    • 2014
  • Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

The Convergence Study of Stress Coping and Satisfaction with Clinical Practice to the Grade of Nursing Student's (간호대학생의 학년별 임상실습 스트레스 대처와 실습 만족도에 관한 융합 연구)

  • Park, In-Sook
    • Proceedings of the Korea Contents Association Conference
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    • 2019.05a
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    • pp.419-420
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    • 2019
  • 본 연구는 학년별 임상실습 스트레스 대처와 실습 만족도를 규명하는 조사연구이다. 연구대상자는 K도 J시에 소재한 임상실습 경험이 있는 간호대학생 3학년은 141명, 4학년 142명 총 283명이다. 자료 분석은 SPSS 18.0 WIN 프로그램을 사용하였고, 대상자의 스트레스 대처 중 소극적인 대처 유형은 총 96점에서 3학년 63.75(${\pm}6.57$)점으로 4학년 62.21(${\pm}6.45$)점 보다 높게 나타났으며, 학년간 차이는 통계적으로 유의미하게 나타났다(t= 1.75, p=.045). 대상자의 실습 만족도는 학년간 차이는 실습시간에 대한 만족도가 통계적으로 유의미하게 나타났다(t=2.87, p=.003). 대상자의 스트레스 대처와 실습만족도와의 관계에서는 적극적 대처 유형과 실습내용 만족도(r=.151, p<.05), 소극적 대처 유형과 실습시간 만족도(r=.138, p<.035)는 양의 상관관계를 나타났다. 종합해보면 추후 실습 스트레스에 대한 대처방법으로 임상 실습 전 긍정적이고 목표지향적인 형태를 유지할 수 있는 자극적이고 효율적인 교과과정과 비교과과정에서의 융합 연구가 필요하다고 사료된다.

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A Statistical Approach to the Pharmacokinetic Model (집단 약동학 모형에 대한 통계학적 고찰)

  • Lee, Eun-Kyung
    • The Korean Journal of Applied Statistics
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    • v.23 no.3
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    • pp.511-520
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    • 2010
  • The Pharmacokinetic model is a complex nonlinear model with pharmacokinetic parameters that is some-times represented by a complex form of differential equations. A population pharmacokinetic model adds individual variability using the random effects to the pharmacokinetic model. It amounts to the nonlinear mixed effect model. This paper, reviews the population pharmacokinetic model from a statistical viewpoint; in addition, a population pharmacokinetic model is also applied to the real clinical data along with a review of the statistical meaning of this model.

Using a Normal Test Variable(NTV) for clinical research (임상 자료 분석을 위한 NORMAL TEST VARIABLE(NTV)의 고찰)

  • 이제영;우정수;최달우
    • The Korean Journal of Applied Statistics
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    • v.11 no.1
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    • pp.129-139
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    • 1998
  • This article examines the use and some difficulties of Normal Test Variables(NTV) plot for clinical research. Monte Carlo Simulation results are presented based on Normal, Bimodal, Uniform, Exponential and skewed-right distributed Beta Distributions. Further, some solutions are presented and illustrated.

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Sample Size Determination Comparing Survival Distributions in the Stratified Clinical Trials (층화된 임상시험에서 생존분포의 비교를 위한 표본수의 결정)

  • 김선우;박미라;이재원
    • The Korean Journal of Applied Statistics
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    • v.12 no.1
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    • pp.175-190
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    • 1999
  • 생존시간을 비교하기 위한 임상시험에서는 생존기간과 관련된 위험인자들을 고려한 층화된 연구설계가 종종 요구된다. 이 경우 필요한 표본수가 결정은 층이 없는 경우에 비하여 다양한 연구상황과 복잡한 표본수의 산출 절차를 수반한다. 본 논문에서는 층이 있는 경우 생존시간을 비교할 때 필요한 표본수를 결정하는 방법들을 실례와 함께 설명하고, 연구자가 주어진 상황하에서 적절한 방법을 선택하는데 도움이 될 수 있도록, 다양한 상황을 설정하여 이에 대한 표본수를 비교하였다.

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