• Journal of Hospice and Palliative Care
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• v.13 no.1
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• pp.1-6
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• 2010

The purpose of clinical trials is to find evidences for the effects of experimental new drugs or treatments on human. For the successful clinical trials, it is not sufficient to use statistics only for the analyses of collected data, but it is necessary to extend the usage of statistics in various ways. At the beginning of the study, one needs to use statistics for systematically and concretly planning the study. For this, we discussed the usage of statistics in defining the effect, determining the sample size, statistical analyses, and so on.

• Journal of Korean Neurosurgical Society
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• v.40 no.4
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• pp.304-308
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• 2006

Statistical analyses used in clinical articles published on the Journal of Korean Neurosurgical Society were identified and appropriateness of statistical aspects in reporting results was assessed. Forty seven clinical articles were selected in this study, which were published from February, 2005 to February, 2006 on the journal. The frequency of statistical analysis was as follows : descriptive statistics only 24 [51.1%]. one type of statistical method 10 [21.3%], two or more methods 13 [27.6%]. An assessment of statistical aspects was performed in 24 clinical articles reporting inferential statistics. Ten articles [41.7%] did not adequately describe or reference all statistical methods used. There were six articles [25.0%] not reporting the confidence level used as the critical criteria of the statistical significance. In thirteen articles [54.2%] it seems more appropriate to implement multivariate analyses in addition to univariate analyses. We recommend that the journal readers should concentrate on improving their knowledge of basic statistics and statistical review for manuscripts submitted should be sought from professionals in the fields of biostatistics and epidemiology.

• The Korean Journal of Applied Statistics
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• v.24 no.4
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• pp.633-646
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• 2011

Clinical vaccines studies (that include cancer prevention vaccines and therapeutic vaccines) are ongoing to improve the quality of life and lengthen the human lifespan. Recently clinical trials and research on vaccines have become more active due to the prevalence of new viruses such as the A(H1N1) virus that freighted the whole word in 2009. In this paper we will describe the statistical aspects of clinical vaccine trials and outline the current situation of domestic and international vaccine development.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.39 no.5
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• pp.203-206
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• 2013

Statistics is the science of data. As the foundation of scientific knowledge, data refers to evidentiary facts from the nature of reality by human action, observation, or experiment. Clinicians should be aware of the conditions of good data to support the validity of clinical modalities in reading scientific articles, one of the resources to revise or update their clinical knowledge and skills. The cause-effect link between clinical modality and outcome is ascertained as pattern statistic. The uniformity of nature guarantees the recurrence of data as the basic scientific evidence. Variation statistics are examined for patterns of recurrence. This provides information on the probability of recurrence of the cause-effect phenomenon. Multiple causal factors of natural phenomenon need a counterproof of absence in terms of the control group. A pattern of relation between a causal factor and an effect becomes recognizable, and thus, should be estimated as relation statistic. The type and meaning of each relation statistic should be well-understood. A study regarding a sample from the population of wide variations require clinicians to be aware of error statistics due to random chance. Incomplete human sense, coarse measurement instrument, and preconceived idea as a hypothesis that tends to bias the research, which gives rise to the necessity of keen critical independent mind with regard to the reported data.

• The Journal of the Convergence on Culture Technology
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• v.9 no.1
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• pp.501-511
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• 2023

Purpose: The purpose of this study was to investigate relationship among self-directed learning, confidence of performance, clinical learning environment and Clinical Competency of nursing students. Methods: 178 nursing students participated. Data analysis was performed using descriptive statistics, t-test, ANOVA and pearson's correlation coefficients with IBM SPSS Statistics 21.0. Results: Mean score of self-directed learning, confidence of performance, clinical learning environment and clinical competency was 3.36, 3.42, 3.20 and 3.66 points. There was significant positive correlation among self-directed learning, confidence of performance, clinical learning environment and clinical competency. Conclusion: Therefore, in order to improve the clinical competency of nursing students, it is necessary to systematize core nursing skills education and continuously improve the clinical learning environment through close industry-academia cooperation and relationship.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.10
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• pp.6019-6023
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• 2013

Lung cancer, one of the leading causes of cancer-related deaths, usually appears as solitary pulmonary nodules (SPNs) which are hard to diagnose using the naked eye. In this paper, curvelet-based textural features and clinical parameters are used with three prediction models [a multilevel model, a least absolute shrinkage and selection operator (LASSO) regression method, and a support vector machine (SVM)] to improve the diagnosis of benign and malignant SPNs. Dimensionality reduction of the original curvelet-based textural features was achieved using principal component analysis. In addition, non-conditional logistical regression was used to find clinical predictors among demographic parameters and morphological features. The results showed that, combined with 11 clinical predictors, the accuracy rates using 12 principal components were higher than those using the original curvelet-based textural features. To evaluate the models, 10-fold cross validation and back substitution were applied. The results obtained, respectively, were 0.8549 and 0.9221 for the LASSO method, 0.9443 and 0.9831 for SVM, and 0.8722 and 0.9722 for the multilevel model. All in all, it was found that using curvelet-based textural features after dimensionality reduction and using clinical predictors, the highest accuracy rate was achieved with SVM. The method may be used as an auxiliary tool to differentiate between benign and malignant SPNs in CT images.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.9
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• pp.5325-5329
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• 2013

Objectives: Although there are many reports about the risk of breast cancer, few have reported clinical factors including history of breast-related or other diseases that affect the prevalence of breast cancer. This study explores these risk factors for breast cancer cases reported in Beijing in 2009. Materials and Methods: Data were derived from a Beijing breast cancer screening performed in 2009, of 568,000 women, from 16 districts of Beijing, all aged between 40 and 60 years. In this study, multilevel statistical modeling was used to identify clinical factors that affect the prevalence of breast cancer and to provide more reliable evidence for clinical diagnostics by using screening data. Results and Conclusion: Those women who had organ transplants, compared with those with none, were associated with breast cancer with an odds ratio (OR)=65.352 [95% confidence interval (CI): 8.488-503.165] and those with solid breast mass compared with none had OR=1.384 (95% CI: 1.022-1.873). Malignant tendency was strongly associated with increased risk of breast cancer, OR=207.999(95% CI: 151.950-284.721). The risk of breast cancer increased with age, $OR_1$=2.759 (95% CI: 1.837-4.144, 56-60 vs. 40-45), $OR_2$=2.047 (95% CI: 1.394-3.077, 51-55 vs. 40-45), $OR_3$=1.668 (95% CI: 1.145-2.431). Normal results of B ultrasonic examination show a lower risk among participants, OR= 0.136 (95% CI: 0.085-0.218). Those women with ductal papilloma compared with none were associated with breast cancer, OR=6.524 (95% CI: 1.871-22.746). Therefore, this study suggests that clinical doctors should pay attention to these high-risk factors.

• Journal of the Korean Data and Information Science Society
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• v.21 no.6
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• pp.1343-1351
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• 2010

Sample size determination is very important part in clinical trials because it influences the time and the cost of the experimental studies. In this article, we consider the Bayesian methods for sample size determination based on hypothesis testing. Specifically we compare the usual Bayesian method using Bayes factor with the decision theoretic method using Bayesian reference criterion in mean difference problem for the normal case with known variances. We illustrate two procedures numerically as well as graphically.

• The Korean Journal of Applied Statistics
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• v.24 no.3
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• pp.495-503
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• 2011

When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

• Journal of Oriental Neuropsychiatry
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• v.18 no.3
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• pp.15-21
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• 2007

This study was done to review problems in terms of statistical description and statistical application and analysis. Methods; The authors reviewed 42 statistical clinical study papers excluding 12 Overview papers, 75 Descriptive papers, 48 Animal studies out of 177 papers in the Journal of Oriental Neuropsychiatry in the 5 years from 2002 to 2006. Results : 1) 3 papers(7.1%) had no description of statistical method, only P-values, 25 papaers(59.5%) had tables without description of statistical method, 1 paper (2.3%) had no description of statistical method in study method. 2) 10 papers(23.8%) contained problems in terms of statistical application and analysis. 6papers (6/23, 26.0%) for Student t-test, 2 papers(2/7 28.6%)for $X^2$- test, 1 paper(1/15 6.7%) for the analysis of variance, 1 paper(1/6 16.7%) for Pearson correlation contained statistical problems. Conclusion : It was suggested that consultation of investigators with statisticians and more extensive statistical refereeing, the form of the guidelines for description and application of statistics are needed.