• Title/Summary/Keyword: 다기관 임상연구

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Medical Dataset Management System for Multi-Center Clinical Research (다기관 임상연구를 위한 의료 데이터 셋 관리 시스템)

  • lee, Chung-Sub;Kim, Seung-Jin;Kim, Ji-Eon;No, Si-Hyeong;Kim, Tae-Hoon;Yoon, Kwon-Ha;Jeong, Chang-Won
    • Annual Conference of KIPS
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    • 2020.05a
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    • pp.16-19
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    • 2020
  • 본 논문은 국제표준화인 OHDSI OMOP-CDM 의 확장으로 의료영상 표준기반의 R_CDM 으로 변환하고 그 데이터를 기반으로 다기관 임상연구를 위한 관리시스템에 대해 기술한다. 이를 위해 기존 공통데이터모델과 연계에 중점을 두어 DICOM 태그정보를 기반으로 의료영상 표준 모델의 스키마와 다기관 연구를 위한 Report 정보를 포함하여 모델링하였다. 이를 기반으로 머신러닝 기술개발을 위한 데이터 셋 생성과 관리를 위한 웹 기반 시스템 구조와 기능에 대해서 기술한다. 끝으로 구현된 시스템에서 제공하는 웹 서비스 수행 결과를 보인다.

Development of Online Registration System for Clinical Research on Korea COPD Population (한국 만성폐쇄성폐질환 환자 대상 임상 연구를 위한 온라인 등록 시스템 구축)

  • Park, Jisook
    • Journal of Internet Computing and Services
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    • v.22 no.1
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    • pp.89-98
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    • 2021
  • Community-acquired pneumonia (CAP) is a major risk factor of mortality in chronic obstructive pulmonary disease (COPD). Streptococcus pneumoniae (colloquially known as pneumococcus) is one of important pathogens of CAP in patients with COPD. Preventive interventions for pneumonia include pneumococcal and influenza vaccinations. A prospective, cohort study has been performed to investigate the protective effects of pneumococcal and influenza vaccinations on the severity of community-acquired pneumonia requring hospital admission in patients with COPD. Seven university-affiliated hospitals in Korea have participated in the study. The aim of this study was to construct an online registration system for the multi-institutional researchers that facilitates efficient collection and management of COPD patient data. This study has presented three basic strategies-accurate data input, convenient data completion, and real-time data management-to supplement the demerits of existing offline clinical study. The proposed online registration system has already been applied to a multi-institutional clinical study and was acknowledged for its high performance.

Effect Analysis of Electronic Clinical Trial Systems (효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석)

  • Lee, Hyun-Ju;Choi, In-Young
    • 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.

Quality Assurance of Gastric Cancer Surgery (위암 수술의 질 관리)

  • Lee Hyuk-Joon;Yang Han-Kwang
    • Journal of Gastric Cancer
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    • v.5 no.2
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    • pp.79-88
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    • 2005
  • Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)

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A Nonparametric Stratified Test Based on the Jonckheere-Terpstra Trend Statistic (Jonckheere-Terpstra 추세 검정통계량에 근거한 비모수적 층화분석법)

  • Cho, Do-Yeon;Yang, Soo;Song, Hae-Hiang
    • The Korean Journal of Applied Statistics
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    • v.23 no.6
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    • pp.1081-1091
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    • 2010
  • Clinical trials are often carried out as multi-center studies because the patients enrolled for a trial study are very limited in one particular hospital. In these circumstances, the use of an ordinary Jonckheere (1954) and Terpstra (1952) test for testing trend among several independent treatment groups is invalid. We propose a the stratified Jonckheere-Terpstra test based on van Elteren (1960)'s stratified test of Wilcoxon (1945) statistics and an application of our method is demonstrated through example data. A simulation study compares the efficiency of stratified and unstratified Jonckheere-Terpstra trend tests.

A Joint Frailty Model for Competing Risks Survival Data (경쟁위험 생존자료에 대한 결합 프레일티모형)

  • Ha, Il Do;Cho, Geon-Ho
    • The Korean Journal of Applied Statistics
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    • v.28 no.6
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    • pp.1209-1216
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    • 2015
  • Competing-risks events are often observed in a clustered clinical study such as a multi-center clinical trial. We propose a joint modelling approach via a shared frailty term for competing risks survival data from a cluster. For the inference we use the hierarchical likelihood (or h-likelihood), which avoids an intractable integration. We derive the corresponding h-likelihood procedure. The proposed method is illustrated via the analysis of a practical data set.