• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.16 no.5
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• pp.205-212
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• 2016

Recently, researches for the integration and standardization of clinical data in the Western medicine and Korean medicine is in progress. If an integration of similar clinical data as well as heterogeneous clinical data is possible based on one standardization, we can able to derive implicit medical knowledge from integrated clinical data. In this paper, we implemented Korean clinical database based on internationally known CDISC standardization to efficiently store Korean clinical data and constructed E-CRF system for convenient data input in clinical sites. Furthermore, we showed example of an integration of Korean clinical data from 4 clinical sites. The results of our study will help to establish the foundation for the extraction of implicit medical knowledge from integrated clinical data. Also, our results may support efficient management through data integration, prevention of repetitive or unnecessary clinical trials, facilitation of collaborative study and convenient research through the distribution of refined clinical data.

• The Journal of the Korea Contents Association
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• v.12 no.12
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• pp.714-720
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• 2012

With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.

• Journal of Internet Computing and Services
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• v.13 no.1
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• pp.45-55
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• 2012

Electronic data management is getting important to reduce overall cost and run-time of clinical data management with the enhancement of data quality. It also critically needs to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop the performance evaluation framework in electronic clinical data management. Four key metrics in the area of infrastructure, intellectual preparation, study implementation and study completion covering major aspects of clinical trial processes are proposed. The performance measures evaluate the extent of regulation compliance, data quality, cost and efficiency of electronic data management process. They also provide measurement indicators for each evaluation items. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management - clinical site, monitoring and data coordinating center. As of the initial attempt how to evaluate the extent of electronic data management in clinical trials by Delphi survey, further empirical studies are planned and recommended.

• Korean Journal of Oriental Medicine
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• v.16 no.2
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• pp.101-108
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• 2010

Objectives : Recently, in Sasang Constitution Medicine (SCM), many researchers have studied to construct objective diagnose tool for the SCM type. It is most important to collect correct constitutional clinical data in these studies. Methods : In our work, we construct a web-based system for collecting constitutional clinical data effectively. Results & Conclusion : The system offers 4 types of input programs, which helps to collect clinical information from various hospitals, and performs verification service to minimize input errors. Currently, we have collected about four thousands data using the our system and we will provide several analysis tool in the system for researchers.

• The Journal of the Korea Contents Association
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• v.11 no.1
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• pp.350-356
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• 2011

The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.10
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• pp.5149-5153
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• 2012

Introduction: This study assessed the relationship of E-cadherin mRNA and protein expression with the diagnosis of lung cancer with the aim of providing an auxiliary diagnostic method. Methods: Semi-quantitative nested RT-PCR and western blotting were applied to detect E-cadherin mRNA transcripts and protein, respectively, in 30 cases of diagnostic lung cancer, 30 cases of clinically suspected patients with lung cancer and 30 cases of other disease. Immunohistochemical staining was also used to detect E-cadherin. Results: Remarkably decreased levels of relative E-cadherin mRNA value and increased E-cadherin protein negativity were observed in probable lung cancer, when compared with possible lung cancer and others. With a threshold of 1.45, relative E-cadherin mRNA value showed a sensitivity of 90% and a specifity of 83% for the diagnosis of lung cancer. The combination of decreased relative E-cadherin mRNA value and negative E-cadherin protein increased the specificity and sensitivity. Conclusion: These data suggest that Chinese patients with diagnostic lung cancer have similar decreased levels of relative E-cadherin mRNA and E-cadherin protein value in the lung cancer tissues as in lung cancer patients in other countries. Measurement of relative E-cadherin mRNA and protein values in lung cancer tissues has potential for lung cancer diagnosis.

• YAKHAK HOEJI
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• v.45 no.2
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• pp.153-160
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• 2001

This research developed an intravenous (IV) vancomycin dosing nomogram based on the clinical pharmacokinetic data of Korean adult patients. Total 99 pairs of steady-state peak and trough serum concentrations of vancomycin were obtained from 73 adult patients in a tertiary general hospital. Serum vancomycin concentrations were determined to assess the appropriateness of initial vancomycin dosing. Only 47.2% of the cases were within therapeutic range. To characterize the clinical pharmacokinetics (PK) of vancomycin, PK parameters including elimination rate constant ( $K_{e}$) half-life( $T_{1}$2/), clearance (C $l_{van}$), volume of distribution ( $V_{d}$) were calculated by using one-compartment, first order pharmacokinetic equations. PK parameters were evaluated based on the differences of patients'renal function and age. Regression analysis showed a significant correlation between C $l_{van}$ and $C_{cr}$ (C $l_{van}$ = -1.89+0.914 $C_{cr}$ , r=0.763) and between $K_{e}$ and $C_{cr}$ , ( $K_{e}$=-0.0037+0.00139 $C_{cr}$ =0.724). The relationship between $K_{e}$ and $C_{cr}$ , and the mean $V_{d}$ were utilized for developing the nomogram to individualize the initial dosing regimen of vancomycin for the patients with various degrees of renal functions. The nomogram may be used as an efficient tool to determine safe and effective doses of vancomycin for the Korean adult patients.nts.nts.nts.s.nts.

• Journal of The Korean Society of Clinical Toxicology
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• v.6 no.1
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• pp.25-31
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• 2008

Purpose: Acute organophosphate (OP) poisoning may be monitored by measuring the acetylcholinesterase (AChE). It is important to assess severity and establish prognostic tests in the early stage of OP poisoning. The aim of this study was to look at the relationship between various clinical aspects of the OP poisoning, prognostic indicators of OP poisoning including Simplified Acute Physiology Score (SAPS) 3, and the associated changes in AChE levels. Methods: Clinical data and initial AChE levels from thirty-seven patients with OP poisoning were prospectively reviewed from 12 teaching hospitals in South Korea from August 2005 to July 2006. Clinical manifestations at the time of arrival such as miosis, respiratory abnormality, salivation, urinary incontinence, GCS score, AVPU scale, need for intubation, and mechanical ventilation requirements were recorded. SAPS 3 was calculated using clinical data and laboratory results. Results: The median level of AChE was 9.8 (1.3-53.6) U/gHb. There was no significant difference in AChE levels between the groups with and without cholinergic symptoms. The median level of AChE of the patients who required intubation and those who did not were 3.5 U/gHb and it 19.7 U/gHb respectively (Mann-Whitney test; p<0.001). The AChE levels were also significantly different (p=0.007) in patients who needed mechanical ventilation compared to those who did not with AChE levels found to be 3.1 U/gHb and it was 14.8 U/gHb, respectively. Level of consciousness assessed using the AVPU scale was correlated with AChE levels (Kruskal-Wallis test; p=0.013). GCS score were correlated with AChE levels (p=0.007, Spearman's rho = 0.454). In addition, the lower the level of initial AChE, the longer the ICU stay (p=0.029, Spearman's rho=-0.380). SAPS 3 was inversely correlated with the initial AChE (p<0.001, Spearman's rho=-0.633). Conclusion: In the acute OP poisoning, low AChE levels appear to help indicate the severity of poisoning. The initial AChE level may be a useful prognostic parameter for acute OP poisoning.

• Journal of Sasang Constitutional Medicine
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• v.24 no.2
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• pp.47-53
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• 2012

1. Objectives : The aim of the present study was to describe the Korea Constitutional Multicenter Bank (KCMB), which was various clinical data bank for scientific advancement of constitutional diagnosis and treatment. 2. Methods and Results : The KCMB is based on the 28 multi-institute cooperative clinical research networks including domestic and international institute. Since the KCMB was founded in 2006, data have been accumulated from 10,412 subjects. The KCMB consists of three parts: The clinical constitutional data, the measurement data, and the biological data. The method of data entry is via web based electronic Case Report From (eCRF). The eCRF has been developed and programed to ensure the efficient entry of data. We also developed coding manual, ongoing quality control assessment to obtain high-quality data. 3. Conclusions : The KCMB with various data contribute to providing the scientification of Sasang Constitutional Medicine.

• Journal of Biomedical Engineering Research
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• v.32 no.2
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• pp.134-143
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• 2011

The selection of meaningful clinical tests and its reference values from a high-dimensional clinical data with imbalanced class distribution, one class is represented by a large number of examples while the other is represented by only a few, is an important issue for differential diagnosis between similar diseases, but difficult. For this purpose, this study introduces methods based on the concepts of both discernibility matrix and function in rough set theory (RST) with two discretization approaches, equal width and frequency discretization. Here these discretization approaches are used to define the reference values for clinical tests, and the discernibility matrix and function are used to extract a subset of significant clinical tests from the translated nominal attribute values. To show its applicability in the differential diagnosis problem, we have applied it to extract the significant clinical tests and its reference values between normal (N = 351) and abnormal group (N = 101) with either cholecystitis or cholelithiasis disease. In addition, we investigated not only the selected significant clinical tests and the variations of its reference values, but also the average predictive accuracies on four evaluation criteria, i.e., accuracy, sensitivity, specificity, and geometric mean, during l0-fold cross validation. From the experimental results, we confirmed that two discretization approaches based rough set approximation methods with relative frequency give better results than those with absolute frequency, in the evaluation criteria (i.e., average geometric mean). Thus it shows that the prediction model using relative frequency can be used effectively in classification and prediction problems of the clinical data with imbalanced class distribution.