• 제목/요약/키워드: Clinical standards

검색결과 467건 처리시간 0.024초

텍스트기반 임상데이터의 인터페이스 용어 매핑 방법 (Method of The Interface Terminology Mapping based Free Text Medical Data)

  • 유돈식;배인호
    • 반도체디스플레이기술학회지
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    • 제13권1호
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    • pp.97-99
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    • 2014
  • Since 2010, issues for data sharing and data exchanging in hospital information systems have been emerged. In order to solve the issues, standards should be applied to develop the systems and there should be no ambiguities between terminologies in the systems. In this paper, the terminology mapping system for narrative clinical records was implemented. The term mapping precision was 83.4%. This system could help to upgrade the text based clinical system and it would be expected to support for high quality clinical services.

Current Status and Strategies of the Efficacy and Safety Evaluation in Drug Approval Process

  • Park, In-Sook;Park, Chang-Won
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.22-24
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    • 2003
  • This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

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중환자실 간호사의 중환자간호 실무표준 이행에 대한 조사 (ICU Nurses' Compliance with Standards for Critical Care Nursing Practice)

  • 이영희;정연이;김미순;김순희
    • 기본간호학회지
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    • 제17권4호
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    • pp.478-486
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    • 2010
  • Purpose: To explore nurses' compliance with standards for critical care nursing practice in intensive care units (ICUs) and to provide basic data for high quality of critical care nursing. Method: A total of 616 participants from 61 ICUs which are graded from 1 to 7 throughout the nation were surveyed. Data were collected from February 9 to February 27, 2009 using a questionnaire consisting of 58 questions including 50 nursing activities as indicators. Results: The rate of ICU nurses' compliance with standards for critical care nursing practice was high. As for individual standards, compliance with the standard of assessment was the highest, followed by implementation, diagnosis, and planning in that order. There were differences in compliance according to nurses' ICU experience, work place (unit), and ICU grade. A shortage of manpower was considered as a main cause for noncompliance. Conclusion: The present compliance rate with standards for critical care nursing practice by ICU nurses was identified. Therefore, compliance rate can be used to promote quality of critical care nursing and development of educational programs for ICU nurses.

상지말초신경손상에 대한 침술치료의 효과: 체계적 문헌고찰 (Acupuncture for Upper Extremity Peripheral Nerve Injury: A Systematic Review)

  • 김영준;김태령;우창훈;신병철
    • 한방재활의학과학회지
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    • 제28권2호
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    • pp.73-82
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    • 2018
  • Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

한의 임상 연구에 대한 국내외 제언 고찰 - 미래 임상 연구 전략 II - (Study on the Proposals for Clinical Research in Korean Medicine Worldwide - Future Clinical Research Strategy II -)

  • 정기용;이민혜;최유경;이충열;박종형;전찬용
    • 동의생리병리학회지
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    • 제29권2호
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    • pp.115-126
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    • 2015
  • The purpose of this paper is to explore the strategy of future Korean medicine(KM) clinical research through the study on the proposals for KM clinical research worldwide. In this study, the papers published in English through Pubmed were investigated mainly. Among them, we analyzed the methodological proposals from the clinical research papers that were published in the KM related fields. Various proposals for improving the problems in KM clinical studies are as follows. First, KM clinical research should be designed based on understanding for the theory, backgrounds, paradigms and worldviews of KM. In addition, considering the model validity, KM clinical research model should include the diagnosis, interventions and outcomes measurement methods reflecting the characteristics and real practice in KM. The internal validity and external validity should be also taken into account. One of the most important thing is to identify the contents about various and complex 'real practice' in KM. A prospective observational study was suitable for the purpose of this study. Finally, we suggested a few improvement directions for RCTs studies in KM. First, we would be able to improve the quality and the internal validity in KM clinical research using the checklists of CONSORT(Consolidated Standards for Reporting Trials) Statement and STRICTA(Standards for Reporting Interventions in Clinical Trials of Acupuncture). Second, we could use various clinical research methods and the modified research of RCTs such as PCT(pragmatic clinical trial) to reflect the characteristics of actual KM practice. Consequently, we would be able to improve the external validity. Third, the KM diagnosis and outcomes measurement methods should be developed based on an actual KM practice and it should reflect a real practice. The 'pattern identification(辨證)' is the core to KM diagnosis. But in order to be applied to the clinical research, the pattern identification(辨證) should be objectified and standardized. Future KM clinical research model should reflect the characteristics and a real practice in KM. In addition, it should include the advantage of rigorous RCTs research.Specially, the diagnosis, interventions and outcomes measurement methods in KM clinical research should reflect this view.

Measurement and Clinical Analysis of Carotid Intima, Media and Intima-Media Thickness

  • Kim, Wuon-Shik;Jeong, Hwan-Taek;Bae, Jang-Ho
    • International Journal of Vascular Biomedical Engineering
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    • 제3권1호
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    • pp.6-13
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    • 2005
  • Individual clinical significance of each layer of CCA (common carotid artery) has not been well studied. We intended to measure the intima thickness (IT), media thickness (MT), and intima-media thickness (IMT) of CCA separately and tried to analyze the clinical significance. One hundred fifty one consecutive patients (mean age: $57{\pm}15$ years; 77 males, 74 females) underwent CCA scanning using high-resolution ultrasound. The images were off-line analyzed using B-mode ultrasound image processing, devised for individual measurement of IT and MT as well as IMT. The mean coefficients of variation of new method measuring IT, MT, and IMT separately were 0.16% for IMT and 0.21% for both IT and MT. The IT (p < 0.01), MT (p < 0.01) as well as IMT (p < 0.001) of patients with atherosclerotic disease were significantly thicker than that of the patients without atherosclerotic disease. Patients with hypertension showed significantly thicker IT (p < 0.01), MT (p < 0.001), and IMT (p < 0.001) than that of the patients without hypertension. However, only IT was thicker in patients with smoking (p<0.01) than that of the patients without smoking.

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영국 브라이튼대학교 물리치료학과의 직무중심 교육과정 적용 사례 연구 (Case Study for Application of Job Centered Curriculum in Department of Physiotherapy: Brighton University in England)

  • 송주영
    • 대한물리의학회지
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    • 제13권2호
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    • pp.97-107
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    • 2018
  • PURPOSE: This study investigated the job-centered curriculum in the Department of Physiotherapy at the University of Brighton, England, to examine NCS (national competency standards) curriculum in physiotherapy. METHODS: The researcher visited the University of Brighton from September 2015 to May 2016 and conducted interviews with faculty members. Data were collected through the university's website and the Chartered Society of Physiotherapy. RESULTS: The undergraduate program is a three-year program and with a module system. There is a course leader for each module. Each grade requires 120 credits (10 hours per credit) and credit hours can be earned through lectures, tutorials, practical sessions, self-directed e-learning, group work, inter-professional classes, and seminars. Clinical placement is carried out six times during 3 years, for a total of 32 weeks, 35 hours per week, 1120 hours in total. Students are enrolled as a student members of the Chartered Society of Physiotherapy and are covered by professional liability insurance during clinical placement. The Center for Teaching and Learning holds regular workshops to discuss curriculum and module design, conduct course reviews, and review student assessment and feedback. All courses at the university must be approved, monitored annually, and re-approved every 5 years. CONCLUSION: This study can contribute to the development and operation of the NCS physiotherapy curriculum, as well as to the development of modules and assessment tools related to the application of this curriculum.

국제표준 기반의 임상정보 관리체계 구축에 관한 연구 (A Study on System for International Standard(IS) based Clinical Information Management)

  • 최용정
    • 한국컴퓨터정보학회:학술대회논문집
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    • 한국컴퓨터정보학회 2014년도 제49차 동계학술대회논문집 22권1호
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    • pp.429-432
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    • 2014
  • 국내 제약산업의 경쟁력을 제고시키기 위해서는 신약의 심사/허가 기간을 단축시켜 급변하게 변하는 글로벌 제약시장에서 경쟁 우위적 위치를 선점할 수 있도록 기회를 제공할 수 있도록 체계 개선이 시급하다. 신약허가를 위해서는 임상시험 결과에 대한 안전성과 유효성 등에 대한 심사가 수행되게 된다. 하지만 현재 신약허가를 위해서 제약사와 임상시험수탁기관(Contract Research Organization, CRO)에서 데이터 정보체계인 Domain, Variable 및 Parameter 등의 표준을 따르지 않고 다양한 유형의 임상정보데이터를 심사기관에 제출하고 있어 이로 인한 심사기간 증가와 심사업무 비효율성을 야기시키고 있다. 따라서 본 연구에서는 국제민간기구인 CDISC (Clinical Data Interchange Standards Consortium)에서 제정한 글로벌 임상데이터 표준인 CDISC 표준을 준용한 국내 임상시험정보관리 체계 (eCTD 시스템)및 의약품 전주기적 관리체계를 제시하고자 하며, 본 연구를 통한 기대효과로는 국제표준의 임상정보관리 인프라 구축으로 인한 국내 신약개발 및 해외 진출 환경을 마련하여 글로벌 시장선점의 기회를 제공할 수 있고, 규제기관 차원에서는 의약품 허가, 심사업무의 효율성 증가는 물론 전주기적 의약품 안전관리체계를 마련할 수 있을 것으로 사료된다.

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한국 임상약학은 어디로 달려가는가?: 한국 임상약학 발전을 위한 제안서 (Is it too Audacious to Challenge: Roadmap for a Primetime of Clinical Pharmacy in Korea)

  • 민보경
    • 한국임상약학회지
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    • 제21권2호
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    • pp.182-187
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    • 2011
  • The Korean pharmacy education has been facing extraordinary challenges. Clinical pharmacy has been embraced into mainstream in the new curriculum since its introduction in Korea. Although these changes are positive to provide our graduates adequate knowledge and skills to meet international standards of pharmacy education, current preparedness is far from desired goals. Thus, faculty members and clinical pharmacy experts from diverse walks are tirelessly committed to develop clinically oriented educational sites. However, it is important to recognize that pharmacy practice, research, and education should be aligned with the $Profession^{\circ}{\Phi}s$ vision. Most faculty members in clinical pharmacy were unexceptionally expected to tackle educational challenges with new curriculum. All academicians must profess throughout their career. Fundamental component in academic career is research accomplishments. The prosperity of clinical pharmacy inevitably goes with research. Clinical researchers in Korea are underprivilaged over basic scientists due to less funding opportunity, administrative support, and research resources. Clinical pharmacy researchers should further overcome poor recognition among other healthcare professionals and government. Aggressive networking and support and awareness of pharmacy oriented clinical research from the Korean college of clinical pharmacy would nurture clinical pharmacy research. With research progress, clinical pharmacy would be prerogative in Korean pharmacy advance.

간호대학생의 임상실습에서의 눈치 경험 (Nursing Student's Experiences on Nunchi in Clinical Practice)

  • 박현주;안효자
    • 한국간호교육학회지
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    • 제25권1호
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    • pp.48-57
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    • 2019
  • Purpose: This study aimed to explore and understand nursing students' nunchi experiences in clinical practice. Methods: Participants were nursing students in the third and fourth years who had clinical experience. A total of 20 nursing students were divided into three focus groups based on their grade levels and gender. Data were collected from December 2017 to March 2018 through focus group interviews and were analyzed via Colaizzi's phenomenological methodology. Results: The study results consisted of 5 theme clusters, 11 themes, and 24 subthemes. These clusters were: confusion about ambiguous behavioral standards, effort in following social norms, concern about getting hurt, physical and psychological exhaustion, and forming social attitudes. Conclusion: These results show that nunchi has positive and negative effects on the clinical practice of nursing students. We need to improve the causes of nunchi, which can have a negative impact on clinical practice.