• Journal of Sasang Constitutional Medicine
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• v.26 no.3
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• pp.224-240
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soyangin Disease of Sasang Constitutional Medicine(SCM): Diagnosis and Algorithm. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods We searched the literature and articles related to Soyangin Symptomatology diagnosis and algorithm. For developing diagnosis and algorithm, we searched the classification, ordinary symptom, present symptom of the Soyangin Symptomatology. Results & Conclusions We classify the Soyangin Symptomatology by 4 steps: Exterior-Interior disease, favorable-unfavorable pattern, mild-moderate-severe-critical pattern (initial-advanced pattern). And at the unfavorable pattern, ordinary symptom is very important. So doctors need to focus on the symptom of unfavorable's ordinary symptom such as temperament inclined symptom, diarrhea, and diurnal body fever.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.173-206
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• 2019

This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

• Quality Improvement in Health Care
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• v.4 no.1
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• pp.82-103
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• 1997

Background : With increased concerns about variation among physician's practice pattern and their impact on the quality of care, clinical practice guidelines have been developed by many different organizations, with differing aims and incentives. From the same point of view, there is growing interest in the development of clinical practice guidelines in Korea, but with only a few examples. As a result, there is not much exploration on the incentive and barrier to develop guidelines as well as description on the development process. The purposes of this study are to describe the process of the four different clinical practice guidelines in a hospital setting, and to identify incentives and barriers in the development of guidelines. Methods : For this research, a clinical practice guideline development committee and four clinical practice guideline development teams were organized in a university hospital which has more than 1,200 bead. Twenty eight doctors, three nurses, and one technician participated as members of development teams for eight months. Four to six meetings were held, and three to seven departments in the hospital were involved. Results : The topics which developed into clinical practice guidelines were cardiopulmonary resuscitation(CPR), blood transfusion, anticoagulation, and angiography. The main goals set by teams were education(CPR, angiography), risk management(blood transfusion), and to enhance quality of care(anticoagulation). Among four teams, only in the team for anticoagulation guideline medical record review and pilot-testing were performed. Also literature review was not carried out systematically. However, all the guidelines were developed by multidisciplinary be used as standard protocols in the practice. Conclusion : Experience and skill in developing process has to be improved to have a more valid and useful practice guideline. In particular, literature review and problem identification by examining medical record should be emphasized. Also further studies on the clinical outcomes of the guidelines application and changes in physicians' behaviors would be required.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• 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.

• Quality Improvement in Health Care
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• v.7 no.1
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• pp.46-58
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• 2000

Background : Despite favorable effects of guidelines on patient care, guidelines often fail to achieve their objectives. Poorly implemented medical practice guidelines can produce only weak effects on the process of health care delivery. Therefore, we performed this study to investigate barriers related development of clinical practice guidelines. Methods : Cardiopulmonary resuscitation was selected as a target problem. Self questionnaires about management of cardiopulmonary resuscitation were developed by a researcher with advisory 8 experts. The questionnaires were designed as a unstructured methods. The data were collected from March 1 to May 31, 1999. A total 50 death case admitted inpatient to Inha University Hospital were subjected to evaluate the development and application of clinical practice guidelines for cardiopulmonary resuscitation. The data were examined by frequency, t-test with SPSS. Result : The article reviewed several common barriers that might limit successful implementation of guidelines in clinical practice, as illustrated by evaluating recommendations for cardiopulmonary resuscitation clinical practice guidelines. Some major problems with guidelines were characterized as follows (1) ethical problem : euthanasia, (2) occurrence on various emergency event and setting, (3) non-medical problems (4) unreliable of medical record etc. Conclusion : Careful analysis of guideline attributes, anticipated effect on medical care, and organizational factors revealed several barriers to successful guideline implementation that should be addressed in the design of future guideline-based interventions.

• Journal of Sasang Constitutional Medicine
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• v.26 no.1
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• pp.45-54
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Greater Yin Symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, 1 article was selected and included in CPG for Greater Yin Symptomatology of Stomach Cold-based Interior Cold disease in Soeumin disease. Results & Conclusions CPG of Greater Yin symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Greater Yin symptomatology is classified into mild and moderate pattern by severity. Greater Yin Symptomatology Mild pattern is classified into Greater Yin Symptomatology accompanied abdominal pain and bowel irritability and Greater Yin pattern accompanied Epigastric stuffiness and fullness. And Greater Yin Symptomatology moderate pattern is classified into Greater Yin pattern accompanied Jaundice, Greater Yin pattern accompanied Edema and Greater Yin pattern by Yin toxin.

• Journal of Sasang Constitutional Medicine
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• v.26 no.1
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• pp.27-36
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Congestive Hyperpsychotic symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, no article was selected and included in CPG for Congestive Hyperpsychotic symptomatology of Kidney Heat-based Exterior Heat disease in Soeumin disease. Results & Conclusions CPG of Congestive Hyperpsychotic symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Congestive Hyperpsychotic symptomatology is classified into mild and severe pattern by severity. Congestive Hyperpsychotic symptomatology mild pattern is classified into initial pattern. Congestive Hyperpsychotic symptomatology severe pattern is classified into intermediate and advanced pattern and Greater Yang disease Reverting Yin pattern.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.13-29
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• 2017

Objectives: The objective of this review is to investigate the use of conventional Western medicine (WM) and complementary and alternative medicine (CAM) on leg cramps. Leg cramps are the occurrence of muscular spasm in the leg muscles which occur frequently in the elderly and are frequently observed in the clinical field. Methods: Relevant clinical studies were searched from five medical databases including PubMed, KISS, RISS, OASIS, and J-STAGE. Systematic review, clinical studies, and clinical practice guideline were included in this review. Results: In total, 27 clinical studies, 9 systematic review and meta-analysis, and 1 clinical practice guideline met the inclusion criteria. Included studies were classified and analyzed according to the type of intervention. Studies on quinine and magnesium have been most studied in WM and CAM, respectively. Although quinine shows some clinical effects on leg cramps, however, the risk of side effects are suggested. In addition, magnesium failed to improve the clinically significant effects in most studies. Five case reports using Oriental herbal medicine (OHM) were included and OHMs were effective in improving leg cramps without side effects, however, the quality of evidence was low. Clinical studies on other interventions were lacking. Conclusions: The results of this study indicate that there is no definite treatment standard for leg cramps until now, and there are limitations such as low level of evidence and side effects for each treatment. OHM can be an effective alternative to conventional intervention on leg cramps, therefore, related clinical studies are needed.

• Journal of Sasang Constitutional Medicine
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• v.26 no.1
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• pp.37-44
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Yang Depletion Symptomatology. Methods This CPG was developed by the national-wide experts committee consisting of the society of Sasang Constitutional Medicine. it was performed by search and collection of literature related SCM, opinion of SCM experts and journal search. And it was followed by CPG's guideline. Results & Conclusions No article was selected and included in CPG for Yang Depletion Symptomatology of Kidney Heat-based Exterior Heat disease in Soeumin disease. CPG of Yang Depletion symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Yang Depletion symptomatology is classified into severe and critical pattern by severity. Yang Depletion Symptomatology severe pattern is classified into initial phase pattern and intermediate phase pattern. And Yang Depletion Symptomatology critical pattern is classified into advanced phase pattern.