• Title/Summary/Keyword: Clinical standards

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Statistical Analysis of Bioequivalence Study in $3{\times}2$ Crossover Design ($3{\times}2$ 교차설계법에서 생물학적 동등성 시험의 통계분석)

  • Park, Sang-Gue;Kim, Jeong-Il;Chae, Sung-San;Ko, Seoung-Gon;Oh, Hyun-Sook;Yang, Wan-Youn;Kim, Dong-Sup;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.28 no.4
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    • pp.231-239
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    • 1998
  • A $3{\times}2$ crossover design is considered for the bioequivalence of two test formulations with a control. It could be considered as a better choice over $3{\times}3$ crossover design because of the cost and experimental duration. Oh et al.(1998) derived $3{\times}2$ crossover design and discussed its benefits over the typical crossover designs. We consider here the statistical models for $3{\times}2$ crossover design and show its statistical properties. The statistical procedures for the bioequivalence in $3{\times}2$ crossover design are shown through an example and the results are summarized by satisfying the 3 standards that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence.

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The CDA-based System Design and Implementation for the Exchange of ECG Reports Between Heterogeneous Systems (이기종간 심전도 판독지 교환을 위한 CDA에 기반한 시스템 설계 및 구현)

  • 전명주;이창건;최진욱;김인영;김선일
    • Journal of Biomedical Engineering Research
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    • v.25 no.5
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    • pp.415-419
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    • 2004
  • As the medical environment field has been facilitated by the rapid development of the information technologies and ubiquitous healthcare service based on network, the exchange of medical information between hospitals become more and more important. However, although most electrocardiograph vendors have provided digital modalities and their ECG data management systems, these were proprietary and not compatible with each other due to multiplicity of vendor specific formats and lack of open ECG data standards. Therefore, we aim to design and develop the ECG management system for archiving, saving, searching, viewing and transferring ECG data and the diagnostic reports. And the system is based on Clinical Document Architecture (CDA) developed by HL7 and DICOM Waveform Standard for the exchange of the structured diagnostic reports and the transfer of ECG data.

Evaluation of Clinical Effectiveness of 3D Digital Endoscopic Image (3차원 디지탈 내시경 영상의 임상적 효용성 평가)

  • Song, Chul-Gyu;Kim, Kyeong-Seop;Kim, Nam-Gyun
    • Korean Journal of Digital Imaging in Medicine
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    • v.5 no.1
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    • pp.26-31
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    • 2002
  • This paper represents the design of 3D endoscopic video system in order to improve visualization and enhance the ability of the surgeon to perform delicate endoscopic surgery. Minimally invasive techniques have set new standards in all surgical may experience less post-operative discomfort, shorter hospitalization, and quicker recuperation. Finally, the aim of the present study was to determine the influence of 2D and 3D video imaging on defined tasks on a laparoscopic trainer.

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The Present Situation of Oriental Health Care in North Korea (북한의 한방보건의료 현황)

  • Kim, Dal-Rae
    • The Journal of Korean Medicine
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    • v.19 no.2
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    • pp.153-176
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    • 1998
  • There are many differences in the present conditions of Oriental Health care and the study of Sasang Constitution Medicine between in North Korea and South Korea. 1. The government of South Korea hasn't supported Oriental Medicine with administrative plans but that of North Korea has supported it positively and made efforts to systematize it. 2. The government of North Korea has considered Oriental Medicine and Western Medicine as mutual supplementary relationship and tried to harmonize them, invested human being and material resources in developing affirmative aspects of Oriental Medicine. That efforts of them made O.M of North Korea developed. 3. In North Korea, they has studied about the principles of O.M. generally in a laboratory. 4. In North Korea, only herbs nation warrant and satisfy standards and fixed orders can be circulated. 5. Because the Sasang Constitution Medicine is opposite to aspect of Materialism, they exclude that from Korean Medicine subjects. They only use them for clinical remedy. But recently, they concern Sasang Constitution Medicine more and more. So also in South Korea, we need to strengthen the political support of the government and the research of laboratory.

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Development of Nursing Handoff Practice Guideline and Standards for Korean Hospital (국내병원 간호사의 인수인계 실무표준, 표준지침 및 표준화된 항목 개발에 대한 연구)

  • Kim, Eun Man;Yu, Mi;Lee, Hyang Yuol;Ko, Ji Woon;Cho, Eui Young;Kim, Eul Soon
    • Journal of Korean Clinical Nursing Research
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    • v.20 no.1
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    • pp.1-14
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    • 2014
  • Purpose: Addressing current status of nursing handoff provides information as to where to change practice for improvement in patient care. The aim of this study was to develop nursing a handoff practice guideline and standardsfor Korean hospitals. Methods: A questionnaire was used to collect data in a cross-sectional survey with 207 head nurses and 697 nurses working in general hospitals. Results: The practice guideline consisted of 2 items on purpose of handoff, 5 items on policy, 3 on environment, 5 on process, 7 on content, 3 on evaluation, and 1 on the function of education, for a total 26 of items. Standard instruction was developed related to Patients, Assessment, Situation, Safety concerns, Background, Actions, and Recommendations. Conclusion: The findings of this study indicate that the guideline can be applied in real nursing practice to improve the effectiveness of handoff procedures. It can be used to guide nurses to follow the standardized content, which presents patient details clearly. The guideline provides consistency and structure for the information that is handed over.

Clinical application of bone graft materials in dental implant (임상가를 위한 특집 3 - 기능별 뼈이식재의 임프란트 적용방법)

  • Ahn, Kang-Min
    • The Journal of the Korean dental association
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    • v.48 no.4
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    • pp.275-279
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    • 2010
  • Dental implant restoration in partial or full edentulous state has become the standard treatment in recent years. Bone graft with guided bone regeneration technique has been regarded as one of the most reliable methods to restore the bone defect area due to periodontal disease or dental trauma. Bone graft materials and membrane are the essential component of guided bone regeneration; however, a variety of bone graft materials confuse us in implant dentistry. Autogenous bone is the recognized standards in implant dentistry owing to its osteogenesis potential. Despite of its disadvantages, grafting autogenous bone is the most reliable methods. Even though the development of new bone grafts materials, autogenous bone is useful in exposed implant thread and total lack of buccal or lingual bone. Allogenic, xenogenic and synthetic bone have the osteoconductive and osteoinductive potential. These materials could be used successfully in self-contained cavity such as sinus cavity and three-wall defects. In this article, application of bone graft material is suggested according to the function of bone graft materials.

Medical Ethics Education: Its Objectives and Curriculum (의료윤리교육의 목적 및 과정에 대한 고찰)

  • Lee, Ilhak
    • Korean Medical Education Review
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    • v.16 no.3
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    • pp.147-155
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    • 2014
  • Medical ethics has been integrated into the curriculum for medical education in Korea for over 30 years now. There have been many attempts to establish standards for the educational objectives and curriculum, including establishing learning outcomes and publishing medical ethics textbooks in Korean. However, this task is not easy for several reasons: the interdisciplinary nature of the subject, educators' lack of experience, and the lack of a consensus on the criteria that would be effective educational goals. In this article, the author explores (1) the need for reflection on the education itself, (2) two perspectives of medical ethics education, (3) critical perspectives on the effectiveness of the current medical ethics education, and (4) the variety of modalities of medical ethics education. Further, the author proposes a way to teach medical ethics in Korea. The contents and means are closely related to the question of philosophy of medical education: "Should professional ethics education be 'realistic' or 'idealistic'?" Ethics requires educators to be open to new learning experiences and to ethical development. Medical Ethics education should be relevant to everyday clinical experiences and, at the same time provide students and educators to critically review their ethical perspective through reflections.

An Implementation of Intefrated Database for Electronic Medical Record System in East-West Medical Collabration (${\cdot}$양방 협진 전자의무기록 시스템 구축을 위한 통합 데이터베이스 구축)

  • Ahn, Yo-Chan;Oh, Sang-Bong
    • Journal of Information Technology Applications and Management
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    • v.12 no.2
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    • pp.129-143
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    • 2005
  • In recent years, two major streams in medical information systems are:1) system integration among OCS(Order Communication System), EMR(Electronic Medical Record), PACS(Picture Archiving and Communication System), and ERP(Enterprise Resource Planning) and 2) system integration through medical collaboration between East and West medical service providers. One of the characteristics which differentiate the Korean medical industry from the western medical industry is the East-West medical collaboration. In many respects there are many differences between East and West medical treatment. Although East and West medical treatment have developed from different medical philosophies and standards, we assume that the better medical care can be provided by integrating their medical procedures effectively. The two possible approaches to the integration of East and West medical information systems are suggested in this paper:One is loosely coupled model and the other is tightly coupled model. EMR improves the quality of medical record which reflects the quality of clinical practice. It provides more efficient and convenient way of input, retrieval, storage, communication and management of medical data. We abstracted the standard medical procedures from the two medical procedures performed in Daejeon Oriental Hospital and Hehwa Clinic at Daejeon University and also abstracted database schema by analyzing the characteristics of information needed in East-West medical collaboration. Our EMR is composed of two types of data:one is structured data and the other is unstructured data, which are formalized by SOAP(Subjective, Objective, Assessment, Plan) format. Currently the integrated system is implemented and operated successfully for six months.

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Design and Implementation of Medical Compound Stimulator Using Low/High Frequency and Cooling Stimulation (저주파/고주파와 냉자극을 이용한 의료용 조합 자극기의 설계 및 구현)

  • Yoon, Wan-Oh;Kang, Suk-Youb;Jung, Jin-Ha;Choi, Sang-Bang
    • Journal of Biomedical Engineering Research
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    • v.29 no.1
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    • pp.82-87
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    • 2008
  • In this paper, the study was carried out to design and implement the medical compound stimulator based on the preexisting individual medical stimulators with Low frequency, High frequency and cooling stimulation. The proposed equipment is designed to compound all the functions including a cooling stimulation with a range of $0{\sim}20^{\circ}C$ and the verified low and high frequencies of 250Hz, 500Hz, 1KHz and 1MHz respectively from the previous clinical experiment with a consideration of its credibility and efficiency. Also, it was constructed by using a new technique, thermoelectricity semiconductor with a consideration of miniaturization and stability. In accordance with patients' treatment purpose, the hand piece of low frequency/cooling stimulation and High frequency/cooling stimulation were separately designed for convenience. The frequency, accuracy and other factors of implemented medical compound stimulator was satisfied according to its measurement. It was also tested by Korean Testing Laboratory (KTL) for its stability and efficacy and it confirmed that the medical compound stimulator is suitable for use as it fits in with the medical equipment standards.

Adoption of CDA(Clinical Document Architecture) for reporting laboratory results (검사실 정보 교류를 위한 임상문서표준규격의 적용)

  • Song, Joon-Hyun;Kim, Il-Kon;Lee, Sung-Hyun;Do, Hyoung-O;Yeah, Jung-Hoon
    • Proceedings of the Korean Information Science Society Conference
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    • 2007.06b
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    • pp.21-26
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    • 2007
  • HITSP(Healthcare Information Technology Standards Panel)은 헬스 케어 관련 산업의 상호 운용성을 위해 일반적으로 수용되고 유용한 표준들을 선별하여 표준 세트를 제공하는 것을 목적으로 한다. HITSP에서는 평생전자건강진료정보(EHR, Electronic Health Record)의 활성화를 위해 첫 번째 해결해야 할 영역으로 검사실 결과 정보 교류를 정하였다. 이에 본 논문에서는 검사실 결과 정보 교류를 위한 방법으로 HITSP에서 제시하는 HL7 버전 2.x 메시지와 CDA 방법 중 인증(authentication) 처리가 가능하고 영속성(persistence)이 있는 CDA 방법을 선택하였다. 또한 CDA를 작성하고 처리하는 방법을 제시하고, 더 나아가 평생전자건강진료정보(EHR)를 위해 CDA를 적용하여 검사실 결과 정보를 교류하여 보았다. 이에 병원과 EHR 시스템의 상호 운용성이 높아져 진료 과정의 효율성을 높일 수 있었고 환자와 의료진에게 양질의 검사 결과 정보를 제공할 수 있었다.

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