• 제목/요약/키워드: standard practice guideline

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GOOD LABORATORY PRACTICE -PRINCIPLES AND PRESENT STATUS IN JAPAN

  • Omori, Yoshihito
    • Toxicological Research
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    • 제1권1호
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    • pp.31-41
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    • 1985
  • The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

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병원약국 대상으로 정맥영양제 조제 실행에 관한 연구-2009 (Survey of Pharmacy Practice for Compounding Parenteral Nutrition in Hospital Setting - 2009)

  • 신혜연;정기화
    • 약학회지
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    • 제54권4호
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    • pp.244-251
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    • 2010
  • Standardized parenteral nutrition is required to improve patient's safety, clinical appropriateness and to increase uniformity between institution and institutions. We assessed the consistency with the American society for parenteral and enteral nutrition (A.S.P.E.N.) practice guideline for PN by evaluating current practice process for parenteral nutrition formulation in inpatients pharmacies in Korea. Each question in this survey was based on 2007 A.S.P.E.N. recommendations of standard parenteral nutrition formulation, the American society of health-system pharmacists (ASHP), and the United State Pharmacopoeia (USP) Chapter 797 guideline for compounding parenteral nutritions. All 90 Korean society of hospital pharmacist (KSHP) member directors of pharmacy were requested to respond to the survey in order to compare the survey results to ASHP national survey of pharmacy practice in hospital settings (2002) in compliance with A.S.P.E.N. guideline. We had final response rate of 35.6%. 25 (100%) hospitals complied with this Garb guideline (response rate was 84.4%) which was the highest compliance. Only 17.9% of hospital pharmacies were actively involved in complications monitoring. Monitoring complications and efficacy were least in compliance with the A.S.P.E.N. guideline. 69.0% of Korean pharmacists adjusted medication dosage based on disease state or monitoring laboratory data in compliance with the A.S.P.E.N. guideline. Over 50% of the hospital pharmacies failed to provide and evaluate staff training in aseptic manipulation skills periodically. Korean hospital pharmacies need to comply with the standard practice guideline for compounding sterile preparation in order to provide better quality of parenteral nutrition service for specific patient population.

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

  • 김은만;유미;이향열;고지운;조의영;김을순
    • 임상간호연구
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    • 제20권1호
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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.

RAND 방법으로 합의한 임상진료지침의 정의와 질 평가 기준 (Consensus on definition and quality standard of clinical practice guideline using RAND method)

  • 지선미;김수영;신승수;허대석;김남순
    • 보건행정학회지
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    • 제20권2호
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    • pp.1-16
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    • 2010
  • Background : Clinical practice guidelines are an increasingly familiar part of clinical practice. Moreover, rigorously developed evidence based guidelines has been widely used. However, in Korea, some of published documents as clinical practice guidelines have shown considerable disparity in structure, contents and quality. This is mainly because there is no consensus on the definition and quality standard of clinical practice guidelines. The purpose of this study was to draw consensus on the definition and the quality standard about clinical practice guidelines. Method : We developed a questionnaire about the definition of clinical practice guidelines with inclusion criteria(23 items) and the quality standard(30 items). We selected 9 experts who had prior experience in developing and implementing guidelines. Rating methods for appropriateness of items were adopted from the RAND method. Consensus was drawn in three rounds. Results : Of the 47 items agreed, 40 items were determined to be appropriate. Clinical practice guidelines were defined as "scientifically and systematically developed statements to assist practitioners and patients on making decisions about appropriate health care for specific clinical circumstances." Narrative reviews, systematic reviews or health technology assessment without recommendations, translation of foreign guidelines, guidelines for patients only and training manuals were not considered as clinical practice guidelines. For the quality standard of clinical practice guidelines, 27 items were deemed necessary. Conclusions : The consensus on the definition with inclusion criteria and the quality standard of clinical practice guidelines carries an important meaning as the first attempt to draw a general agreement in our society. The unique achievement of the consensus reflects the current status of clinical practice guidelines that there has been a high tendency to adapt foreign guidelines. We hope efforts of this kind will continue to bring improvement in clinical practice guidelines.

한의 표준임상진료지침 및 한의 표준임상경로에 대한 한의사의 인식 (Korean Medicine Doctor's Perception in Korean Medicine Clinical Practice Guideline and Korean Medicine Cliniical Pathways)

  • 김동수;안해인;권수현;안은지;김남권
    • 대한예방한의학회지
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    • 제26권2호
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    • pp.55-67
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    • 2022
  • Objectives : This study is aimed to survey Korean Medicine Doctors's perceptions in Korean Medicine Clinical Practice Guideline and Standard Korean Medicine Clinical Pathways for its spread(to increase utilization in clinical sites). Methods : The research population was set at 14,831 Korean medical institutions registered with the Health Insurance Review and Assessment Service for sampling representative of Korean Medicine Doctors, and the final 2,007 subjects were selected in consideration of the research period and budget. This survey was conducted based on a telephone survey, and in some cases, a fax or e-mail survey was also conducted together. Six questions were asked about the perception of 'Korean Medicine Clinical Practice Guideline and Standard Korean Medicine Clinical Pathways', and three questions about the characteristics of the respondent. Results : The rate of recognizing Korean Medicine Clinical Practice Guideline was 36.1%. Those who worked at Korean medicine hospitals, were under 39 years of age, and had less than 11-20 years of experience as an Korean medical doctor were more likely to be aware of it. Regarding the experience of using Korean Medicine Clinical Practice Guideline, the rate of 'not used in the past and not used now' was very high at 82.9%, but the intention to use it in the future was high at 60.7%. About the Korean Medicine Clinical Pathways, 79.9% of respondents answered that they did not know. 80.6% of respondents recognized the need for the development of clinical manuals such as Korean Medicine Clinical Practice Guideline and Standard Korean Medicine Clinical Pathways. Conclusion : Their low awareness of Korean Medicine Clinical Practice Guideline seems to affect its low utilization. Therefore, active education and public relations are required in the future.

여자 대학생의 식생활 실천 지침과 체성분에 관한 연구 (Body Composition of Female College Students through Practice by Standard Guideline for Korean Dietary Life)

  • 정희정;장경자
    • 동아시아식생활학회지
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    • 제16권3호
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    • pp.251-260
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    • 2006
  • To study the correlation between body composition values and practice of the Standard Guideline for Korean Dietary Life, a nationwide cross-sectional survey was conducted with 378 female college students living in four Korean cities in December 2005. Among the student subjects, 98 were analyzed for body fat mass, percent body fat, waist-hip ratio(WHR), body mass index(BMI) and obesity degree using Inbody 3.0(Biospace Co, Seoul, Korea). Percent body fat was at a high level of 54.1 %, WHR was at a high level of 58.2% and BMI was at a high level of 41.8%. However, both weight and body fat were below normal at 79.5% and 77.6%, respectively. Percent body fat, WHR, and BMI were slightly negatively correlated with vegetable consumption, but slightly positively correlated with beer intake. WHR > 0.8 was significantly negatively correlated with exercise. Standard Guideline for Korean Dietary Life was practiced to and above normal level by 64.6% of the female college students. However, female college students who are within the normal range of body composition value should notice that obesity will relate to abdominal or visceral fat on their body.

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Delphi방법을 이용한 일차의료 고혈압 진료지침 개발 및 적용 (Establishment and Application of the Guideline for Hypertension by Delphi Method in the Field of Primary Medical Care)

  • 양윤준;홍명호
    • 한국의료질향상학회지
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    • 제2권1호
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    • pp.68-84
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    • 1995
  • Background: Guideline for practice is useful because it can be the standard for assessment and way to improve quality. We need to take account of expert opinion and consensus as well as scientific evidences to develope practice guideline because it should be practical. Delphi method has been developed to gather opinions from experts fairly. This study was designed to develop practice guideline and apply it to practices as a method to improve quality in primary medical care. Methods: Hypertension(in adults over 18 years old) was selected as a target problem. Self questionnaires about management of hypertensive patients were developed by a researcher with advice of 11 experts. The questionnaires were designed to response as a 5 pont scale. The results of previous questionary were given to respondents in second and third questionnaires. If needed, the questionnaires were changed on the previous responses. The items with medium greater than or equal to 4 point in 1st and 2nd responses were accepted in guideline. The items with medium lesser than or equal to 3 point were questioned again about whether they can be excluded or not. The criteria for assessment was made with reference to guideline and applied to 85 hypertensive patients of 9 family practitioners. At 3 months after practice guideline had been given to family practitioners, performance of same practitioners was assessed with 36 new hypertensive patients. Results: 23 professors in family medicine, 22 family practitioners and 6 cardiologists, responded among 50, 50, 15 respectively. Practice guideline with 33 items was developed as a result of 3 times questionaires. The difference of responses between professors in family medicine, family practitioners and cardiologists was not significant. Performance of practice was improved in diagnosis, history taking about 6 fields, laboratory examination and decision making about time of pharmaceutical prescription. It was not improved in physical examination, life style modification, method of pharmaceutical prescription, choice of initial antihypertensives and history taking about duration of disease and diet habit. It was decreased in history taking about psychosocial factors. The assessment scores were low in history taking, physical examination and life style modification before and after use of practice guideline. Conclusion: Practice guideline for hypertension could be developed by Delphi method. Performance of practice improved partially after use of guideline.

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통증관리 근거중심 가이드라인의 국내 타당성 검증 - 복부수술 환자를 대상으로 - (Validation of a Translated Guideline on Pain Assessment and Management: Focused on Abdominal Surgery Patients)

  • 홍성정;이은주
    • 임상간호연구
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    • 제18권1호
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    • pp.159-170
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    • 2012
  • Purpose: This study was designed to examine the validity of the evidence-based guideline on pain developed by Registered Nurses Association of Ontario(RNAO) translated into Korean based on the experts' opinions. Methods: The panel consisted of experts of 60 registered nurses in surgical units, medical doctors and nursing managers who were experts in pain assessment and management. The validity of translated RNAO guideline was evaluated in terms of appropriateness, applicability, and utilization in current practice. Appropriateness and applicability of each recommendation were measured with 9 point scale, whereas utilization was measured by yes/no question. Data were analyzed by mean, standard deviation, and percent. The experts' opinions were analyzed by content analysis method. Results: In general, most of the recommendations in the guideline received above 7 point in appropriateness and applicability. However, above 20% of recommendations showed less than 50% of utilization rates in current practice. Conclusion: The reasons for low utilization of recommendations in current practice are in need for investigation. This study can be used for the development of guideline more acceptable in Korean health care settings and improve the quality of care for the abdominal surgery patients suffering from pain in Korea.

수술환자를 위한 웹 기반 근거중심 실무 가이드라인의 개발 및 평가 (Development and Evaluation of the Web-based Evidence-based Practice Guideline for the Operation Patients)

  • 홍성정;장재식;전영훈;이은주;김화선
    • 인터넷정보학회논문지
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    • 제12권1호
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    • pp.131-139
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    • 2011
  • 본 연구는 수술환자에게 적용할 수 있는 수술 후 통증, 수술 후 오심 구토, 체온관리에 대한 웹 근거중심 실무 가이드라인 시스템을 개발하여 이를 적용하고 수술 환자의 수술 후 통증, 오심/구토, 체온관리에 대한 의료인의 지식정도와 환자의 만족도를 평가하기 위한 것이다. 수집된 자료는 SPSS/WIN 17.0 프로그램을 이용하여 평균, 표준편차, t-test, Repeated ANOVA로 분석하였다. 웹으로 구축한 근거중심 실무 가이드라인 적용 전과 후의 수술 후 통증, 수술 후 오심/구토, 수술환자 체온관리에 대한 지식정도와 환자 만족도에 유의미한 차이가 있었다.

신용장조건(信用狀條件)과 서류심사(書類審査)의 기준(基準) 검토(檢討) (Terms of Letter of Credit and Standard for Examination of Documents)

  • 강원진
    • 무역상무연구
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    • 제13권
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    • pp.495-513
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    • 2000
  • In this paper, I examined the terms of letter of credit and standard for examination of documents. In connection with the test of standard, I reviewed the bank's reasonable care, inconsistence and linkage between documents, non-documentary conditions and the treatment of discrepant documents. Traditionally credit law is founded on two principles such as the standards of strict of compliance and substantial compliance, but these standards are not consistency. Moreover although the Uniform Customs and Practice for Documentary Credits(UCP) introduces a new standard for examination of documents by incorporating international banking practice, the standards for documentary compliance have created ambiguity. Accordingly, I suggest that the standard requires strict compliance between party concerned in letter of credit transactions but only requires international standard banking practice in customer relationship. Therefore the standard and the specific guideline should be prescribed in the next version of the UCP.

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