• 제목/요약/키워드: Guideline

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간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer])

  • 한가진;김동훈;박은주;성신;김성수;임정태
    • 대한한방내과학회지
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    • 제40권1호
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

낙상위험요인 평가 및 낙상예방활동 임상진료지침 (Clinical Practice Guideline for Assessment and Prevention of Falls in Adult People)

  • 천자혜;김현아;곽미정;김효선;박선경;김문숙;최애리;황지인;김윤숙
    • 한국의료질향상학회지
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    • 제24권2호
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    • pp.41-61
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    • 2018
  • Purpose: Falls are one of the most frequent health events in medical institutions, however, they can be predicted and prevented. The Quality Improvement Nurse Society clinical practice guideline Steering Committee developed the Clinical Practice Guideline for the assessment and prevention of falls in adult people. The purpose of this study was to assess the risk factors for falls in adults aged 19 years and older, to present an evidence for preventing falls, formulate a recommendations, and indicators for applying the recommendations. Methods: This clinical practice guideline was developed using a 23-step adaptation method according to the Handbook for clinical practice guideline developer (version 1.0) by National Evidence-based Healthcare Collaborating Agency. Evidence levels and recommendation ratings were established in accordance to SIGN 2011 (The Scottish Intercollegiate Guidelines Network). Results: The final 15 recommendations from four domains were derived from experts' advice; 1) assessment of risk factor for falls in adult 2) preventing falls and reducing the risks of falls or falls-related injury 3) management and reassessment after a person falls 4) leadership and culture. Conclusion: This clinical practice guideline can be used as a basis for evaluation and prevention of fall risk factors for adults, to formulate recommendations for fall risk assessment and fall prevention, and to present monitoring indicators for applying the recommendations.

알레르기 비염 한의표준임상진료지침 방향 제언 - 2018 중국 임상진료지침을 바탕으로 (Suggestions for developing Korean Medicine Clinical Practice Guideline for Allergic Rhinitis - Based on 2018 Chinese Clinical Practice Guideline)

  • 강정인;이동효
    • 한방안이비인후피부과학회지
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    • 제32권4호
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    • pp.130-140
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    • 2019
  • Objective : The purpose of this study is to examine the treatment of allergic rhinitis introduced in the Chinese guideline, and to find out the direction of evidence-establishment and applicability in developing Korean Medicine clinical practice guideline for allergic rhinitis. Method : We studied Traditional Chinese Medicine treatment of allergic rhinitis introduced in the 2018 Chinese society of allergy guidelines for diagnosis and treatment of allergic rhinitis. The treatment are classified into three categories; herbal medicines, acupuncture and the others. And we compared this guidelines with other guidelines for how they differ in description of the database, evidence of level, and strength of recommendation. Results : Herbal medicines are presented based on syndrome differentiation. The basic acupoints for allergic rhinitis are introduced as follows; Fengchi(GB20), Yingxiang(LI20), Feishu(BL13) and Taiyuan(LU9). And in comparison with other guidelines for allergic rhinitis, the Chinese guideline showed lack of description in the database, evidence of level, and strength of recommendation, though they used evidence-based models. Conclusions : Clinical practice guideline projects are also underway in Korea for benefit expansion and improving quality of medical services. It is important to develop guidelines which should be evidence-based and reflect Korean medical environment.

증기운 폭발 사례 비교를 통한 멀티에너지법의 폭발강도계수 지침 개선 (Improvement of Charge Strength Guideline for Multi-Energy Method by Comparing Vapor Cloud Explosion Cases)

  • 이승훈;김한수
    • 한국전산구조공학회논문집
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    • 제34권6호
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    • pp.355-362
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    • 2021
  • 증기운 폭발의 폭압을 예측하거나 위험성 분석을 위하여 다양한 폭압 산정법이 존재하지만 대표적으로 경험적 방법인 TNT 등가량 환산법과 멀티에너지법을 주로 사용한다. 멀티에너지법은 환경적 요인을 고려한 폭발강도계수를 사용한다. 본 연구에서는 문헌 분석을 통하여 점화원 강도를 세분하고 강도분류를 확장하여 개선한 폭발강도계수 가이드라인을 제안하였다. 개선한 폭발강도계수 가이드라인의 합리성 검증과 기존 Kinsella 가이드라인과의 비교를 위하여 실제 추정 폭압과 대조가 가능한 4가지의 증기운 폭발 사례를 적용하였다. 결과적으로 기존 Kinsella 가이드라인은 실제 추정 폭압에 비하여 광범위하거나 부정확한 폭압 산정 결과를 나타내는 것으로 확인하였다. 반면, 개선한 폭발강도계수 가이드라인은 명확한 점화원의 강도 선정이 가능하고 분류의 확장을 통하여 더욱 세분화된 계수 값의 선정이 가능함에 따라 실제 사례와 비교적 유사한 폭압 산정이 가능하다.

전기식 온침기에 대한 안전성 및 성능평가 가이드라인 개발 연구 (A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus)

  • 장한솔;정우령;문정현;최성경;성원석;황민섭;이승덕;김경호;윤종화;김은정
    • 대한한의학회지
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    • 제43권3호
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    • pp.150-163
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    • 2022
  • Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Korean Surgical Practice Guideline for Pancreatic Cancer 2022: A summary of evidence-based surgical approaches

  • Seung Eun Lee;Sung-Sik Han;Chang Moo Kang;Wooil Kwon;Kwang Yeol Paik;Ki Byung Song;Jae Do Yang;Jun Chul Chung;Chi-Young Jeong;Sun-Whe Kim;Committee of the Korean Surgical Practice Guideline for Pancreatic Cancer
    • 한국간담췌외과학회지
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    • 제26권1호
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    • pp.1-16
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    • 2022
  • Pancreatic cancer is the eighth most common cancer and the fifth most common cause of cancer-related deaths in Korea. Despite the increasing incidence and high mortality rate of pancreatic cancer, there are no appropriate surgical practice guidelines for the current domestic medical situation. To enable standardization of management and facilitate improvements in surgical outcome, a total of 10 pancreatic surgical experts who are members of Korean Association of Hepato-Biliary-Pancreatic Surgery have developed new recommendations that integrate the most up-to-date, evidence-based research findings and expert opinions. This is an English version of the Korean Surgical Practice Guideline for Pancreatic Cancer 2022. This guideline includes 13 surgical questions and 15 statements. Due to the lack of high-level evidence, strong recommendation is almost impossible. However, we believe that this guideline will help surgeons understand the current status of evidence and suggest what to investigate further to establish more solid recommendations in the future.

응급실에서의 감염관리 표준지침의 반영에 관한 연구 -응급실에서의 감염관리 표준지침과 응급의료에 관한 법률의 반영 비교를 중심으로- (A Study on an acceptance of CDC guideline on practical emergency department planning -Focusing on comparison CDC guideline to Emergency Medical Service Act-)

  • 윤형진;오준걸
    • 한국산학기술학회논문지
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    • 제16권11호
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    • pp.7237-7243
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    • 2015
  • 응급실은 병원으로 입원하는 주요 경로로서, 감염환자의 1차적 내원의 가능성이 높은 곳이다. 국내에서 질병관리본부가 2009년에 제정한 "응급실에서의 감염관리 표준지침"이 응급실 감염환자 관리 방안과 표준시설기준을 규정하고 있으나 각 병원 응급실의 감염환자 시설은 병원마다 차이가 있고 지침에 따른 일관된 감염환자 관리시설을 갖추었다고 보기 어렵다. 본 연구는 응급실에서의 감염관리 표준지침의 실효성을 알아보기 위해 법적 강제성을 갖는 "응급의료에 관한 법률"과 비교하여, 첫째 지침이 법률 시설기준에 반영된 여부를 분석하였고, 둘째 2009년 전후에 신축 또는 개축한 응급실들을 분석대상으로 하여 각 시설기준 항목들의 반영여부를 파악하였다. 그 결과 지침과 법률 시설기준의 상호연관성은 없었다. 분석대상 응급실들의 시설은 법적기준을 모두 충족한 반면 지침의 감염관리시설은 선별적으로 적용되어 있었고, 설치 항목들이 건축년도에 관계없이 분석대상 응급실에 대부분 적용되어 "응급실에서의 감염관리 표준지침"의 제정과는 무관한 것으로 나타났다. 본 연구 결과는 향후 응급실의 감염관리시설의 법적기준 체계 보완에 참고자료로 활용 될 수 있을 것이다.

수용개작방법을 활용한 의료기관의 격리주의지침 개발 (Adaptation of Isolation Guidelines for Health Care Settings)

  • 류재금;정재심;정인숙;김정혜;홍은영;김향숙;정영선;권정순;이지영;최지연;김경숙;김은현;차경숙;김은진;박경희;서현주
    • 임상간호연구
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    • 제24권2호
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    • pp.209-226
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    • 2018
  • Purpose: This purpose of this study was to develop evidence-based practice guideline for isolation in health care settings to prevent transmission of infectious diseases utilizing guideline adaption process. Methods: The process of guideline adaptation was performed according to the Korean hospital nurses association's guideline adaptation manual which consisted of three main phases, 9 modules, and 24 steps. Results: The adapted isolation guideline consisted of introduction, overview of isolation guideline, summary of recommendations, recommendations, references, and appendices. The guideline includes 224 recommendations in 4 sections which are organizational administration, standard precautions, transmission-based precautions, and education/counselling. Conclusion: The adapted isolation guideline is recommended to be disseminated and utilized by nurses and clinicians nationwide to improve the isolation practices for infected or colonized patients with communicable diseases and to decrease the transmission of infections in the healthcare settings.