• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• Journal of Korean Public Health Nursing
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• v.33 no.3
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• pp.409-419
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• 2019

Purpose: Factors related to the major satisfaction of nursing students were systematically searched and quantitatively synthesized. Methods: Meta-analysis was conducted upon 47 articles in Korean master and doctorate degree dissertations and academic journals. Meta-analysis of major satisfaction-related variables was conducted using Comprehensive Meta-Analysis (CMA) 2.0 program. The effect size of the related variables was analyzed by converting the statistic r value to Fisher's Z. Results: The overall average effect size of major satisfaction was the largest effect size (ES=.49), followed by cognitive factors (ES=.58), affective factors (ES=.45), and psychomotor factors (ES=.31). The cognitive factors were in the order nursing professionalism(ES=.70), nurse's image (ES=.65), and critical thinking disposition (ES=.36). The affective factors were self-esteem (ES=.59), emotional intelligence (ES=.55), career identity (ES=.49), self-efficacy (ES=.48), college adjustment (ES=.45), practice satisfaction (ES=.45), resilience (ES=.42), (ES=.40), grit (ES=.34), and stress (ES=.26). The psychomotor factors were clinical performance ability (ES=.38) and career search behavior (ES=.31). Conclusion: The results of this study are valuable when giving consideration to the variables related to nursing students' major satisfaction, for developing a strategic model to enhance the satisfaction of nursing students.

• Asia-Pacific Journal of Business
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• v.9 no.3
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• pp.117-137
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• 2018

Lots of the studies about the relationship between coaching leadership and organizational effectiveness have been conducted and reported that coaching leadership is one of the main factors which impact organizational effectiveness. The purpose of this study was to synthesize the relationship between coaching leadership and organizational effectiveness. For that purpose, 32 correlation effect sizes from 25 studies were analyzed by the CMA (Comprehensive Meta-analysis) Program. The study calculated the overall effect size of the relationship between coaching leadership and organizational effectiveness. Then, it also calculated the effect size of the relationship between coaching leadership and each sub-variable of organizational effectiveness. The analysis results are as follows: First, the overall effect size about the relationship between coaching leadership and organizational effectiveness was .519, which means that coaching leadership has over lager relationship with organizational effectiveness. In addition, the effect sizes of sub-variables of the organization are .556 (organizational commitment) .542 (job satisfaction), 509 (organizational citizen behavior), and .401 (innovative behavior). The study tested the mediating effects of measurements, organizational size, types of publication, and published year. The result showed that only the measurement made significant differences among effect sizes of studies.

• Journal of the Korean Society of Food Culture
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• v.21 no.3
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• pp.270-279
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• 2006

This study was designed to : (a) analyze the menus of the French restaurant in tourism hotel using the menu analysis techniques of Kasavana & Smith and Pavesic, (b) compare the characteristics of the two analysis techniques. The calculations for the menu analysis were done using the MS 2000 Excel spreadsheet program. The menu mix % and unit contribution margin were used as variables by Kasavana & Smith and weighted contribution margins (WCM) and potential food cost % (PFC%) by Pavesic. In two cases, a four-cell matrix was created and menu items were located in each according they achieved high or low scores with respect to two variables. The items that scored favorably on both variables were rated in the top category (e.g., star, prime) and those that scored below average on both were rated in the lowest category (e.g., dog, problem). While Kasavana & Smith's method focused on customer's viewpoints, Pavesic's method considered the manager's viewpoints. Therefore, it is more likely to be desirable for decision-making on menus if the menu analysis techniques chosen is suited to its purpose.

• Journal of vocational education research
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• v.37 no.1
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• pp.101-118
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• 2018

The purpose of this study was to investigate the effect size of the difference of job satisfaction by type of employment by combining data from previous studies. For this purpose, the total of 95 articles analyzed. For the analysis of data, CMA(Comprehensive Meta-Analysis) 2.0 program was used and statistical significance was set at 5%(${\alpha}=0.05$). The main conclusions of this study are as follows. First, regular workers have higher job satisfaction than non-regular workers and the effect size of employment type is medium. Second, among five constituents of job satisfaction, the difference of wage and promotion satisfaction is greater than the difference of satisfaction in human relations, work and working environment satisfaction. Third, the job satisfaction of regular and non-regular workers differs according to the occupation areas. Fourth, there is a big difference in job satisfaction in financial, insurance, food and service occupation areas, and regular workers have higher job satisfaction than non - regular workers. On the other hand, non-regular workers have higher job satisfaction than regular workers in health, medical, social occupation areas.

• Journal of Industrial Convergence
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• v.21 no.12
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• pp.101-111
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• 2023

This study conducted systematic review and meta-analysis to analyze the effectiveness of a dual-task for cognitive function in patients with MCI in Korea. A search was conducted using eight databases, and the search terms were MCI, cognition, and dual task. This study includes RCT and nonRCT published from January 2013 to July 2023. A total of 682 studies were searched, and 8 studies that fulfilled the inclusion and exclusion criteria were finally analyzed. Methodological quality was assessed with the RoB, RoBANS. The meta-analysis used CMA 4.0 ver. As a result of the analysis, the overall effect size of the dual task was medium effect size. The effect size according to the outcome variables was large for orientation and executive function, and medium effect size for global cognitive function, visuospatial function, memory, and attention. As a result of analysis according to the intervention period, the effect was greater when applied for 4 to 8 weeks, and the effect size was larger when applied for 24 to 30 sessions. This study presented clinical evidence on the effectiveness and application method of a dual-task applied to improve cognitive function in patients with MCI.

• Journal of the Korean Society of Physical Medicine
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• v.11 no.2
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• pp.115-121
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• 2016

PURPOSE: Many studies have reported the improvement of cognition through physical activity among subject with dementia. This study aimed to whether the current studies supports that physical activity intervention is efficacious on cognitive performance in subject with dementia. METHODS: Two independent reviewers searched National assembly library, RISS, KISS (2005-2015) using the concepts of dementia, exercise, and physical activity. We included randomized controlled trials that examined the efficacy of physical activity in subject with dementia. A meta-analysis was performed to estimate the effect sizes cognition with CMA (Comprehensive Meta-Analysis, version 2.2.064) soft-ware program. Nine randomized controlled trials were included, providing data from 133 individuals and excluding those failing to criteria of this study. RESULTS: The meta-analysis showed that physical activity intervention had a rather small effect sizes of 0.36 (95% confidence interval 0.14-0.59) on cognition performance in subject with dementia. Outcome measurement were MMSE-K (Mini-mental state examination Korean version) and LOCTA (Loewenstein Occupational Therapy Cognitive Assessment). We found heterogeneous among studies and there was difference between the studies (Q = 19.63, d(f)=12, $I^2= 38.88$). CONCLUSION: The present analysis suggests that physical activity interventions have the low effect sizes on cognition performance in subject with dementia Further studies will be required to develop the various programs for improving the cognitive performance in subject with dementia.

• The Journal of Asian Finance, Economics and Business
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• v.7 no.10
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• pp.513-521
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• 2020

In this paper, we have developed a Fama - French five factor model (FF5 model) from Fama & French (2015) by using concept of time-varying coefficient. For a data set, we have used monthly data form Kenneth R. French home page, it include Japan portfolios (classified by using size and book-to-market) and 5 factors from July 1990 to April 2020. The first analysis, we used Augmented Dickey-Fuller test (ADF test) for the stationary test, from the result, all Japan portfolios and 5 factors are stationary. Next analysis, we estimated a coefficient of Fama - French five factor model by using a generalized additive model with a thin-plate spline to create the time-varying coefficient Fama - French five factor model (TV-FF5 model). The benefit of this study is TV-FF5 model which can capture a different effect at different times of 5 factors but the traditional FF5 model can't do it. From the result, we can show a time-varying coefficient in all factors and in all portfolios, for time-varying coefficients of Rm-Rf, SMB, and HML are significant for all Japan portfolios, time-varying coefficients of RMW are positively significant for SM, and SH portfolio and time-varying coefficients of CMA are significant for SM, SH, and BM portfolio.

• Journal of Korean Academy of Nursing
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• v.46 no.4
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• pp.475-489
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• 2016

Purpose: This study was a systematic review and meta-analysis designed to investigate the effects of stimulation-oriented interventions for behavioral problems among people with dementia. Methods: Based on the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), a literature search was conducted using seven electronic databases, gray literature, and other sources. Methodological quality was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) for randomized controlled trials (RCTs). Data were analyzed using R with the 'meta' package and the Comprehensive Meta-Analysis (CMA 2.0) program. Results: Sixteen studies were included for meta-analysis to investigate the effect of stimulation-oriented interventions. The quality of individual studies was rated as '++' for eight studies and '+' for the rest. The effect sizes were analyzed according to three subgroups of interventions (light, music, and others); Hedges' g=0.04 (95% CI: -0.38~0.46), -0.23 (95% CI: -0.56~0.10), -0.34 (95% CI: -0.34~0.00), respectively. To explore the possible causes of heterogeneity ($I^2=62.8%$), meta-regression was conducted with covariates of sample size, number of sessions, and length of session (time). No moderating effects were found for sample size or number of sessions, but session time showed a significant effect (Z=1.96, 95% CI: 0.00~0.01). Finally, a funnel plot along with Egger's regression test was performed to check for publication bias, but no significant bias was detected. Conclusion: Based on these findings, stimulation-oriented interventions seem to have a small effect for behavioral problems among people with dementia. Further research is needed to identify optimum time of the interventions for behavioral problems among dementia pateints.

• Journal of Korean Academy of Nursing
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• v.45 no.4
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• pp.469-482
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• 2015

Purpose: The purpose of this study was to identify which nursing interventions are the most effective in fall prevention for hospitalized patients. Methods: From 3,675 papers searched, 34 were selected for inclusion in the meta-analysis. Number of fallers, falls, falls per 1,000 hospital-days, and injurious falls, fall protection activity, knowledge related to falls, and self-efficacy about falls were evaluated as outcome variables. Data were analyzed using the Comprehensive Meta Analysis (CMA) 2.2 Version program and the effect sizes were shown as the Odd Ratio (OR) and Hedges's g. Results: Overall effect size of nursing interventions for fall prevention was OR=0.64 (95% CI: 0.57~0.73, p <.05) and Hedges's g= - 0.24. The effect sizes (OR) of each intervention ranged from 0.34 to 0.93, and the most effective nursing intervention was the education & environment intervention (OR=0.34, 95% CI: 0.28~0.42, p<.001), followed by education intervention (OR=0.57, 95% CI: 0.50~0.67, p=.001). Subgroup analyses showed that multifaceted interventions (OR=0.76, 95% CI: 0.73~0.79, p<.001) were more effective than unifactorial interventions, and that activities for prevention of falls (OR=0.08, 95% CI: 0.05~0.15, p<.001) showed the largest effect size among outcome variables. Conclusion: Falls in hospitalized patients can be effectively prevented using the nursing interventions identified in this study. These findings provide scientific evidence for developing and using effective nursing interventions to improve the safety of hospitalized patients.