• Clinical and Experimental Pediatrics
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• v.52 no.9
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• pp.976-983
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• 2009

Urinary tract infection (UTI), the most common bacterial disease in childhood, is frequently associated with urinary tract anomalies (15-50%) and can induce renal scarring, which is a cause of hypertension and chronic kidney disease. Despite the high risk of renal scarring in infancy, the diagnosis may be delayed due to its nonspecific presenting symptoms; moreover, over-diagnosis is frequent due to the contamination of urine samples. The delay in diagnosis and treatment may induce sepsis or renal scar, while over-diagnosis is responsible for unnecessary antibiotic treatment and costly urinary imaging studies. UTI guidelines have been ever-changing for the past three decades, but some controversial issues remain. This article is a revision of the previous KSPN (Korean Society of Pediatric Nephrology) guideline and addresses the recent controversies concerning childhood UTI.

• Clinical and Experimental Pediatrics
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• v.61 no.2
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• pp.37-42
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• 2018

Hemolytic uremic syndrome (HUS) is often encountered in children with acute kidney injury. Besides the well-known shiga toxin-producing Escherichia coli-associated HUS, atypical HUS (aHUS) caused by genetic complement dysregulation has been studied recently. aHUS is a rare, chronic, and devastating disorder that progressively damages systemic organs, resulting in stroke, end-stage renal disease, and death. The traditional treatment for aHUS is mainly plasmapheresis or plasma infusion; however, many children with aHUS will progress to chronic kidney disease despite plasma therapy. Eculizumab is a newly developed biologic that blocks the terminal complement pathway and has been successfully used in the treatment of aHUS. Currently, several guidelines for aHUS, including the Korean guideline, recommend eculizumab as the first-line therapy in children with aHUS. Moreover, life-long eculizumab therapy is generally recommended. Further studies on discontinuation of eculizumab are needed.

• International Journal of Stem Cells
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• v.17 no.2
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• pp.130-140
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• 2024

Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.13 no.1
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• pp.129-138
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• 2002

Objectives：In order to treatment guideline of ADHD, present clinical practise of child psychiatrists and their opinion of optimal intervention were evaluated. Methods：Structured questionnaire items about diagnostic workup, drug choice of 5 different situations according to different co-morbid disorders, and non - pharmacological treatment were applied to 32 child psychiatrists working at university and general hospital. we compared the data with Texas Algorithm Project guideline. Results：(1) Intelligence Test, Sentence Completion Test, sustained attention test, and Conner's questionnaire were the basic routine test that must be performed. (2) Main trend of medication in this study was not different from TAP guideline. (3) In case of co-morbid tic disorder, first recommending drug is still psychostimulant in the TAP guideline. But in this study initial psychostimulant prescription was not main trend. (4) In case of MPH non-response co-morbid disruptive behavior disorder, MPH medication combined with other drug were more common than switching to other drug as suggested the TAP guidelines. (5) In non-pharmacological treatment, most child psychiatrists reported the importance of parent management. Conclusion：There were some difference in medication trend in this study compared with TAP guideline. Further study and conference are needed for experts consensus in Korea.

• Quality Improvement in Health Care
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• v.20 no.1
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• pp.42-57
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• 2014

Objective: The objective of this research was to develop a guideline for more effective use of physical restraint on patients in the intensive care unit and training the nurses on it and applying it on clinical practice to assess its effectiveness. Method: This research analyzed the before and after effect of the development of a guideline for physical restraint by dividing the category into nurse and patient. In the case of nurse, a comparison of knowledge and nursing service regarding the use of physical restraint from before the training on physical restraint guideline(Jan. 2011) and after the training on physical restraint guideline(Dec. 2011) was made. In the case of patient, a comparison of physical restraint usage rate and average usage time, the number of unplanned extubation cases were compared from before the use of physical restraint (Jan.~Apr. 2011) and after the use of physical restraint (Sep.~Dec. 2011) were made. Result: After the training on the physical restraint guideline, the knowledge of the nurse and the nursing practice showed notable improvement by (p<0.000) and (p<0.048) respectively and in patient, physical restraint usage rate and average time of usage decreased by (p<0.001) and (p<0.001) respectively. And despite the decrease in the number of cases in which the physical restraint was used, the number of unplanned extubation cases remained the same. Conclusion: Physical restraint guideline training and guideline usage can be stated to have brought out positive effect in both the nurse and patient. In order to maintain such positive effects, continuous training is necessary and continuous revaluation is necessary, regarding knowledge and nursing practices.

• Journal of Acupuncture Research
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• v.27 no.1
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• pp.75-86
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• 2010

Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

• The Journal of Korean Medicine
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• v.44 no.1
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• pp.128-128
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• 2023

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.

• The Journal of Internal Korean Medicine
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• v.37 no.3
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• pp.516-528
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• 2016

Objectives: The purpose of this study is to present clinical practice guidelines for nasopharyngeal cancer (NPC).Methods: Data related to western and oriental medical treatment of NPC were collected using various search engines such as Google Scholar, KIOM OASIS, PUBMED, and the library of Woosuk University.Results: In recent studies, applying combined oriental and western medicine has been shown to improve survival, quality of life, and immune function and to decrease side effects with respect to NPC. However, there still is no objective and systematic clinical guideline for NPC, so we have proposed one. This study will be meaningful in establishing clinical practice guidelines of Korean medicine for NPC.Conclusion: Further studies related to Korean medicine are needed to develop more advanced clinical practice NPC guidelines.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.181-186
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• 2016

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

• Child Health Nursing Research
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• v.28 no.1
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• pp.51-61
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• 2022

Purpose: Practical training in pediatric nursing gives students the opportunity to apply nursing knowledge to children in a realistic clinical context. Clinical practice faculty (CPF) and clinical nursing instructor (CNI) have played important roles in the pediatric nursing practicum. This study was conducted to develop a protocol to guide clinical practicum in pediatric nursing. Methods: A service design methodology was employed between August 2020 and May 2021 at four universities and four hospitals in South Korea. The participants were five CPFs, five CNIs, five nursing college graduates, and 60 nursing students. The service design process had four phases: discovery, definition, development, and delivery. Data were collected through self-report questionnaires, in-depth interviews, and observations. The data were analyzed using content analysis and descriptive statistics. Results: The participants reported needs for providing concrete guidance and explanation, nursing practice experience, and a link between school and the clinical field. A protocol was developed to fulfill the participants' needs. The protocol comprised detailed information, teaching methodology, and partnership to guide students in the pediatric nursing practicum. Conclusion: The protocol developed in this study can be used to provide guidance for students' clinical practice in the field of pediatric nursing.