• 제목/요약/키워드: Clinical standards

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비의사 전문 유전상담사의 교육 및 자격의 인증을 위한 소고 (A Review on Professional non-MD Genetic Counselors for Education and Accreditation in Korea)

  • 김현주;도성탁
    • 대한임상검사과학회지
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    • 제41권3호
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    • pp.93-104
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    • 2009
  • This short review was aimed to provide the information for the people who are interested in genetic counselor education and certification system in Korea. A large part of this study is indebted to HJ Kim's articles on the genetic counselor system, the global standards of genetic counseling curriculums, training program accreditation (TPA), and a certification process for genetic counselors (CPGC) in the US and Japan. The US and Japanese educational systems showed a high degree of similarities in curriculum, accreditation, and certification programs. Based upon this review, we hereby propose that the Korean Society for Medical Genetics should take a key role in providing the TPA and CPGC for non-MD genetic counselors. Requirement for the entrance to a Master's degree genetic counseling program should be open to successful four year undergraduate students for all areas, provided the candidates demonstrate the abilities to master the graduate level study in human genetics, statistics, psychology, and other required subjects. Besides accredited program graduates, eligibility for certification should also include the qualified candidates of genetic counseling with no formally approved education, but with a sufficient amount of clinical experience.

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아토피피부염의 침 치료 임상연구 동향 (Trend for Acupuncture treatment Clinical Trial on Atopic Dermatitis)

  • 박수연;최정화;정민영;이기현
    • 한방안이비인후피부과학회지
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    • 제33권1호
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    • pp.45-55
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    • 2020
  • Objectives : The objective of this study is to review the Trend of clinical trials conducted with the acupuncture treatment on Atopic Dermatitis. Methods : Through 4 foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and 3 domestic online databases(NDSL, RISS, OASIS), we searched for clinical studies performed acupuncture treatment for Atopic Dermatitis from 2010 to December 2019. Only randomized controlled trials(RCT) was selected and anlayzed according to the research method. Results : A total 4 studies were reviewed. LI11, ST36, SP10 were most frequently used acupoints in acupuncture treatment. Among the evaluation indexes, SCORAD, VAS, DLQI were used most. In most of the 4 studies, acupuncture treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about Acupuncture treatment method as the method of acupuncture is getting more diverse, and objective tools are needed in evaluating Atopic Dermatitis.

Recent Research Trends in Moxibustion Treatment in Korea

  • Lee, Ju-Hyeon;Hwang, Doo-ree;Hong, Seung-Hyo
    • Journal of Acupuncture Research
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    • 제37권1호
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    • pp.1-12
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    • 2020
  • A total of 1,235 studies were retrieved on June 23, 2019, from 3 databases. Selected 59 studies were evaluated by year of publication, study type, subject condition/disease, acupoint, standards for reporting interventions in clinical trials of moxibustion (STRICTOM), Cochrane risk of bias (RoB), and risk of bias assessment tool for non-randomized study (RoBANS). Most studies were conducted in 2011, after which the number of studies decreased. The most common study type was 25 case reports (CR), 16 uncontrolled clinical trials (UCT), 11 randomized controlled trials (RCT), and 7 controlled clinical trials (CCT). Moxibustion treatment was mainly used for musculoskeletal and circulatory diseases/conditions. A total of 83 acupoints were used, A-shi points being the most used. As for STRICTOM, an average of 7.4 items were satisfactory for UCT and CR without a control group, and an average of 9.4 items were satisfactory for RCT and CCT. RCT was assessed using the RoB, and many items were rated as uncertain. In this study, the need for RCT of moxibustion treatment in Korea was identified. The detailed description of study methods and results will provide evidence for the efficacy of moxibustion treatment in preventive and therapeutic aspects of Korean traditional medicine.

Basic Principles of the Validation for Good Laboratory Practice Institutes

  • Cho, Kyu-Hyuk;Kim, Jin-Sung;Jeon, Man-Soo;Lee, Kyu-Hong;Chung, Moon-Koo;Song, Chang-Woo
    • Toxicological Research
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    • 제25권1호
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    • pp.1-8
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    • 2009
  • Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

Comparison of porcine and human acellular dermal matrix outcomes in wound healing: a deep dive into the evidence

  • Saricilar, Erin Cihat;Huang, Sarah
    • Archives of Plastic Surgery
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    • 제48권4호
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    • pp.433-439
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    • 2021
  • Acellular dermal matrices (ADM) are a novel graft. The goal of this systematic review is to evaluate the evidence behind differences in human and porcine ADM, irrelevant of manufacturing method, and to determine if there is enough of an evidence base to change clinical practice. An extensive literature search was performed through MEDLINE and Embase with search terms defining a population, intervention and outcome. Title and abstract exclusion were performed with other exclusion criteria. In 191 articles were found after exclusion of duplicates, with only 29 remaining following exclusions. Ten studies were found to have level I and II evidence (I=3, II=8), of which two were histopathological, one was an animal model, one was a systematic review, and six were clinical. The remaining studies were reviewed and considered for discussion, but did not hold high enough standards for medical evidence. Strong clinical evidence already exists for the use of human ADM, but questions of access, cost, and ethics require consideration of a xenograft. Histopathologically, evidence suggests minimal long-term differences between human and porcine ADM, although there is a short acute immune response with porcine ADM. Clinically, there is limited difference in outcomes, with a small range in effect of different ADM preparations. Considering the effectiveness of ADM in wound healing, more high-level research with appropriate statistical analysis to facilitate a future meta-analysis is recommended to justify a transition from human to porcine ADM.

치위생(학)과 임상실습 표준화 방안 (Study of Clinical Practice Standardization in Dental Hygiene)

  • 신선정;김미정;양진영;유지수;정아연;신명숙
    • 치위생과학회지
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    • 제17권1호
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    • pp.1-11
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    • 2017
  • 전국 82개의 치위생(학)과의 임상실습 교과목은 필수 교과목으로 운영되고 있으며, 임상실습 기관은 대학병원부터 개인 치과의원까지 범위가 넓고, 실습시간별 교육환경이 달라 임상실습 내용과 평가방법이 다양하게 이루어지고 있으며, 치위생학 교육과정과 실무와의 연계 및 전문성 제고를 위한 임상실습 표준화에 대한 요구도가 높아지고 있다. 이에 본 연구에서는 치과위생사 2차 직무기술서와 선행연구에서 파악한 임상실습 항목을 목록화 하여 총 156개 항목 중 74개(47.4%)의 임상실습 내용을 추출하였으며 각 임상실습 내용에 대해 필수 및 선택실습 여부, 실습시기, 활동방법을 구체적으로 제시하였다. 실습일정은 전반부(1주차), 중반부(2~3주차), 후반부(4주차)로 구분하고, 활동방법을 관찰, 준비, 수행, 교육으로 구분하여 임상실습 기관에서 학생들에게 임상실습을 지도할 수 있도록 시범운영을 진행하였다. 각 대학별 교과과정을 기반한 임상실습 내용 배치를 위해서는 임상실습 선수교과목으로 이수한 임상치의학 교과목을 중심으로 임상실습 내용을 구성하도록 하여 단계별로 임상실습 내용을 모두 달성할 수 있도록 해야 하며, 이를 위해서는 교육기관과 임상실습 기관의 유기적인 협력관계뿐 아니라 표준화된 임상실습 프로토콜이 제시되어야 할 필요성이 있겠다.

Efficacy evaluation of syringe pump developed for continuous drug infusion

  • Jung, Bongsu;Seo, Kwang-Suk;Kwon, Suk Jin;Lee, Kiyoung;Hong, Suyong;Seo, Hyounsoon;Kim, Gi-Young;Park, Geun-Mook;Jeong, Juhee;Seo, Soowon
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제16권4호
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    • pp.303-307
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    • 2016
  • Background: In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results. Methods: The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h. Results: In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps. Conclusions: The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use.

Proposal for Comprehensive Quality Control of Heavy-Ion Medical Accelerator

  • Kim, Dong-wook;Shin, Dong-oh;Shin, Young-hoon;Heo, Hyun-do
    • 한국의학물리학회지:의학물리
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    • 제28권2호
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    • pp.67-75
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    • 2017
  • Prior to the introduction of a medical apparatus based on heavy-ion medical accelerator in Korea, a study is needed on quality control in clinical operation for the safe and appropriate usage of the instrument. Data relevant for the study were obtained via information sharing sessions and visits by the Particle Therapy Co-Operative Group (PTCOG) and other related academic associations. Furthermore, investigative analysis of the European and Japanese performance evaluation guidelines for heavy ion, as well as research on relevant literature, were conducted. In addition, instrumental standards were analyzed through an investigation of the current usage status of the heavy-ion medical accelerator, and further analysis was conducted on the evaluation methods for the performance, safety, and significance of the instrument. Based on these analyses, regular quality control procedures for heavy-ion medical accelerators in hospitals and other institutes were extrapolated. It is hoped that the results of this study will facilitate hospitals that have introduced heavy-ion medical accelerators, or are considering the implementation of the instrument, in their understanding of the fundamental standards and capabilities of the treatment system, as well as in establishing and carrying out quality control procedures for clinical operations such that it will contribute to the safety of patients and the efficiency of medical practitioners.

척추신경추나의학회지에 수록된 무작위대조임상 연구의 양적, 질적 분석 (Randomized Controlled Clinical Trials in the Journal of Korean Society of Chuna Manual Medicine for Spine and Nerves: A Quantitative and Qualitative Analysis)

  • 조현우;이현엽;허광호;황의형;신미숙;신병철
    • 척추신경추나의학회지
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    • 제7권2호
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    • pp.15-23
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    • 2012
  • Objectives: The aim of this study is to assess the quantity and quality of randomized controlled clinical trials (RCTs) published in the journal of Korean Society of Chuna Manual Medicine for Spine and Nerves (KSCMSN). Methods: All relevant RCTs were selected and extracted. Data extract of RCTs from all the articles published in the jounal of KSCMSN up to now, quantity assessment was made on the study design, sample size, intervention, control group and medical condition. of the consolidated standards of reporting trials (CONSORT) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus. Results: Among the 276 articles, 10 RCTs were published. 1st articles were published in 2003 and half of RCTs were published in 2011. All RCTs were parallel 2-arm designed. Average sample size was 29.2 per study and 14.6 per arm. Main intervention was consisted as acupuncture 40%, pharmacopuncture 30% and Chuna 30%. Average of adequacy of CONSORT check list was 10.3% and overall reports were insufficient. Conclusions: Though RCTs published in jounal of KSCMSN were increasing, the quality remains low. KSCMSN should make a effort to follow the CONSORT statement and improve the quantity and quality of studies.

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신의료기술 신청 현황과 평가 결과 분석을 통한 한의 신의료기술 개발 방안 (Status of Application and Analysis of Results of New Health Technology Assessment - Strategies for Development of New Health Technology in Korean Medicine)

  • 최영은;김동수;이준환
    • 대한예방한의학회지
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    • 제21권3호
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    • pp.75-85
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    • 2017
  • Objectives : The new health technology assessment (nHTA) involves evaluating the safety and efficacy of the new health technology under the Medical Services Act by the New Health Technology Assessment Project Division from 2007. The purpose of this study is to understand the status of applications and recent trends of the results, and suggest strategies for the development of new health technologies in Korean Medicine. Methods : We investigated and analyzed the results of evaluation of new health technology of whole conventional medical and the list of new health technologies in Korean Medicine provided by the New Health Technology Assessment Project Division from 2007 to 2016. Results : The number of applications for new health technology of Korean medicine was low as 41 items in the whole number of 2,013 items. The evaluation method of new health technologies in both, the whole medical and Korean medicine fields was the same, but the tendency in results was very different. Most of the new health technology items in Korean medicine were classified as existing technology (20 items), early stage technology (7 items), and Only 2 items were evaluated as research stage technology. Conclusions : In order to develop new health technology in the Korean medical field, we have made suggestions about the health technology assessment systems, R&D infrastructures, and corporation with conventional medicines.