• Title/Summary/Keyword: Clinical standards

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Breast Magnetic Resonance Image (MRI) Guideline: Breast Imaging Study Group of Korean Society of Magnetic Resonance in Medicine Recommendations

  • Choi, Seon Hyeong;Kang, Bong Joo;Jung, Seung Eun
    • Investigative Magnetic Resonance Imaging
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    • v.22 no.4
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    • pp.205-208
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    • 2018
  • The purpose of this study is to establish an appropriate protocol for breast magnetic resonance imaging (MRI) in the discipline of image quality standards. The intention of the protocol is to increase effectiveness of medical image information exchange involved in construction, activation, and exchange of clinical information for healthcare.

Mission and Operation of Institutional Review Board (임상시험심사위원회의 임무와 운영)

  • Kim, Yong-Jin
    • Journal of Yeungnam Medical Science
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    • v.30 no.2
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    • pp.73-78
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    • 2013
  • An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

Warm Needling Treatment in Korea: A Literature Review

  • Kim, Chang Wan;Park, Jin Seo;Won, Jee Yeong;Han, Da Young;Lee, Kyoung Yoon
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.69-78
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    • 2020
  • Although there have been studies investigating the clinical effects of warm needling (WN) for specific diseases, a comprehensive review of WN is needed. Four Korean internet databases were used in the review of WN treatment performed in Korea. The search terms used to retrieve articles were "warm needling (in Korean; 온침)," "warm acupuncture," and "warm needle." A total of 29 articles were reviewed. The following aspects of WN were investigated: language and terminology, study design, use of Standards for Reporting Interventions in Clinical Trials of Acupuncture, research ethics, moxibustion types, number of moxa used, moxa combustion time, needle retention time, treatment time and frequency, acupoints, meridians, acupuncture size and depth, disease classification, pattern identification, outcome measures, and adverse effect. More sophisticated and precise studies on WN are required.

Development of Digital Endoscopic Image Processing System (디지탈 내시경 영상처리 시스템의 개발)

  • 송철규;이영묵
    • Journal of Biomedical Engineering Research
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    • v.18 no.2
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    • pp.121-126
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    • 1997
  • Endoscopy has become a crucial diagnostic and therapeutic procedure in clinical areas. Over the past three years, we have developed a computerized system to record and store clinical data pertaining to endoscopic surgery of laparascopic cholecystectomy, pelviscopic endometriosis, and surgical arthroscopy. In this study, we developed a computer system, which is composed of a frame yabber, a sound board, a VCR control board, a LAN card and EDMS(endoscopic data management software. Also, computer system has controled peripheral instruments such as a color video printer, a video cassette recorder, and endoscopic input/output signals(image and doctor's comment). Digital endoscopic data management system is based on open architecture and a set of widely available industry standards, namely: windows 3.1 as a operating system, TCP/IP as a network protocol and a time sequence based database that handles both images and doctor's cotnments. For the purpose of data storage, we used MOD and CD-R. Digital endoscopic system was designed to be able to store, recreate, change, and compress signals and medical images.

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Comparison of Three Antibiotic Susceptibility Tests for Viridans Group Streptococci

  • Kim, Yeon-Hee;Lee, Si-Young
    • International Journal of Oral Biology
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    • v.36 no.4
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    • pp.163-166
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    • 2011
  • Oral viridans streptococci are recognized as one of the etiological agents of a variety of infectious diseases such as dental caries and infective endocarditis. Although antimicrobial susceptibility tests for these fastidious bacterial species are now established and standardized, a comparison between the broth microdilution and broth macrodilution tests has not previously been performed. This comparison was performed in the present study using the tests adopted by the Clinical and Laboratory Standards Institute (CLSI) and seven clinical isolates of oral viridans streptococcal strains. A modified broth macrodilution susceptibility test method was also included in this analysis, in which the media was not supplemented with horse blood. The susceptibility interpretation category agreements were measured at 83% (broth microdilution versus broth macrodilution) and 71% (broth microdilution versus modified broth macrodilution). The interpretation category agreement between the broth macrodilution and modified broth macrodilution tests was also 83%. These data indicate that the interpretation of antibiotic susceptibility test results for oral viridans streptococci are influenced by the methods used.

Quantitative sudomotor axon reflex test (QSART) as a diagnostic tool of small fiber neuropathy

  • Suh, Bum Chun
    • Annals of Clinical Neurophysiology
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    • v.24 no.1
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    • pp.1-6
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    • 2022
  • Small fiber neuropathy is a painful neuropathy that cannot be assessed using nerve conduction studies. A skin biopsy and quantitative sensory testing (QST) are the gold standards for small fiber neuropathy diagnosis. However, a skin biopsy is invasive and commercially unavailable in Korea. QST is a method involving a thermal threshold, but its results can be affected by cognition as well as lesions of the central nervous system. Quantitative sudomotor axon reflex test (QSART) is a quantitative method of assessing sweat glands innervated by small fibers. In this review, we assessed the utility of QSART in evaluating small fiber neuropathy.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.35 no.3
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

Change in the Nursing Professionalism, Role Conflict and Job Satisfaction of the Nursing Students before and after their first Clinical Experience (첫 임상실습이 간호대학생의 전문직관, 역할갈등, 직무만족에 미치는 영향)

  • Park, Eun-Hee;Hang, Ran-Hee
    • Journal of Digital Convergence
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    • v.15 no.1
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    • pp.593-601
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    • 2017
  • This study was attempted to provide nurse students with basic materials to improve their clinical practices, and to investigate changes in their views on Nursing Professionalism, Job satisfaction, and role conflicts. After experiencing clinical practices, their nursing professionalism(t=-2.184, p=.031) and job satisfaction (t=-2.068, p>.001) increased but role conflict (t=-3.729, p>.001) increased as well. They were satisfied with their jobs, building up nursing professionalism through clinical practices. However, they had also acquired time on thinking about their future jobs more deeply than before practices and realizing their roles in real sense. In particular, they felt stress in some of subcategories, personal inner conflicts (t=-3.729, p>.001), role obscurity (t=-5.720, p>.001) so it is necessary to review standards on their job and task in nurse education and clinical practices.

A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System (다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구)

  • Kim, You Rim;Yu, Woo Jin;Park, Ho Joon;Jang, Won Seuk
    • Journal of Biomedical Engineering Research
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    • v.40 no.6
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    • pp.250-259
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    • 2019
  • Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

Position Statements of the Emerging Trends Committee of the Asian Oceanian Society of Radiology on the Adoption and Implementation of Artificial Intelligence for Radiology

  • Nicole Kessa Wee;Kim-Ann Git;Wen-Jeng Lee;Gaurang Raval;Aziz Pattokhov;Evelyn Lai Ming Ho;Chamaree Chuapetcharasopon;Noriyuki Tomiyama;Kwan Hoong Ng;Cher Heng Tan
    • Korean Journal of Radiology
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    • v.25 no.7
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    • pp.603-612
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    • 2024
  • Artificial intelligence (AI) is rapidly gaining recognition in the radiology domain as a greater number of radiologists are becoming AI-literate. However, the adoption and implementation of AI solutions in clinical settings have been slow, with points of contention. A group of AI users comprising mainly clinical radiologists across various Asian countries, including India, Japan, Malaysia, Singapore, Taiwan, Thailand, and Uzbekistan, formed the working group. This study aimed to draft position statements regarding the application and clinical deployment of AI in radiology. The primary aim is to raise awareness among the general public, promote professional interest and discussion, clarify ethical considerations when implementing AI technology, and engage the radiology profession in the ever-changing clinical practice. These position statements highlight pertinent issues that need to be addressed between care providers and care recipients. More importantly, this will help legalize the use of non-human instruments in clinical deployment without compromising ethical considerations, decision-making precision, and clinical professional standards. We base our study on four main principles of medical care-respect for patient autonomy, beneficence, non-maleficence, and justice.