• Journal of Dental Anesthesia and Pain Medicine
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• v.16 no.4
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• pp.253-261
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• 2016

Background: Evidence-based clinical practice guidelines (CPGs) are defined as "statements that are scientifically reviewed about evidence and systematically developed to assist in the doctors' and patients' decision making in certain clinical situations." This recommendation aims to promote good clinical practice for the provision of safe and effective practices of conscious sedation in dentistry. Method: The development of this clinical practice guideline was conducted by performing a systematic search of the literature for evidence-based CPGs. Existing guidelines, relevant systematic reviews, policy documents, legislation, or other recommendations were reviewed and appraised. To supplement this information, key questions were formulated by the Guideline Development Group and used as the basis for designing systematic literature search strategies to identify literature that may address these questions. Guideline documents were evaluated through a review of domestic and international databases for the development of a renewing of existing conscious sedation guidelines for dentistry. Clinical practice guidelines were critically appraised for their methodologies using Appraisal of guidelines for research and evaluation (AGREE) II. Results: A total of 12 existing CPGs were included and 13 recommendations were made in a range of general, adult, and pediatric areas. Conclusion: The clinical practice guidelines for conscious sedation will be reviewed in 5 years' time for further updates to reflect significant changes in the field.

• Korean Journal of Clinical Pharmacy
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• v.26 no.1
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• pp.84-95
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• 2016

Objective: Atrial fibrillation (AF) guidelines have been published in the USA and Europe. Recently, the USA and Europe have updated their guidelines, respectively. These new AF guidelines help in addressing key management issues in clinical situations. This study, therefore, systematically compared guidelines for rate and rhythm control pharmacotherapy of patients with AF between the USA (American College of Cardiology and American Heart Association, ACC/AHA) and Europe (European Society of Cardiology, ESC). Methods: This study investigated and compared American guidelines (2014) and European guidelines (2010 and 2012). Results: Generally, there are four meaningful differences between ACC/AHA and ESC guidelines. Important differences are treatment classification system, level of recommendation, drug list, and dosage. In addition, ACC/AHA described pharmacokinetic drug interactions for antiarrhythmic drugs. ESC emphasized ECG and atrioventricular nodal slowing as feature of antiarrhythmic drugs. Conclusion: This research addresses important use of anti-arrhythmic drugs and movement to accept recent recommendations in Korea. For the successful application of the guidelines, a role of pharmacists is crucial in clinical situation.

• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.90-108
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• 2016

Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

• Journal of Acupuncture Research
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• v.37 no.4
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• pp.224-232
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• 2020

The purpose of this study was to assess the quality of the case reports in the Journal of Acupuncture Research (JAR). All case reports were retrieved from November 2017 to June 2020. There were 19 case reports included in this assessment based on the case report (CARE) guidelines and case report and standards for reporting interventions in clinical trials of acupuncture (STRICTA) guidelines. The overall quality of reporting was relatively high (83.08% on Case Report guidelines and 77.78% on Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines), but several crucial items remained substantially underreported, such as identifying as a case report (keywords), patient information and perspective, clinical findings, diagnostic assessment, and intervention information. In 18 out of 19 included case reports of acupuncture-related interventions, several items remained considerably underreported such as acupuncture regimen variation, depth of needle insertion, response sought, and experience of acupuncturists. In the classification by disease, condition, or syndrome, 13 out of 19 included case reports were for musculoskeletal disorders (68.4%), which is the main clinical medical field of Korean medicine services. The results of this study may help develop more appropriate reporting guidelines for case reports published in JAR.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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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."

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.39-65
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• 2022

There are two aspects of clinical practice guidelines that act as non-legal control before medical practice and as legal control standards after medical practice. The essential purpose of clinical practice guidelines is the former, but the latter action cannot be excluded. The clinical practice guidelines are a means of linking law and medical care. The negative perception of clinical practice guidelines that medical professionals' autonomy can be violated by the enactment of clinical practice guidelines is an excessive negative evaluation of clinical practice guidelines. Rather, judicial judgment based on clinical practice guidelines plays a role in respecting the autonomy of medical professionals. In other words, the clinical practice guidelines suppress legal regulations on medical care as much as possible and are based on doctors' professional ethics and self-discipline, and patient awareness and cooperation. In order to establish an ideal relationship of cooperation between doctors and patients, 'medical ethics' must be incorporated as a legal means. Clinical practice guidelines are the most appropriate means for incorporating such medical ethics into legal procedures. The lawyer solves the case with a legal syllogism that establishes a norm and applies facts to it to conclude. For the resolution of medical disputes, Clinical practice guidelines are used to establish norms that doctors should perform for specific diseases, and conclusions are drawn by applying the established norms to specific medical practices. When it is not easy to apply the established norms to specific medical practices, medical judgments by experts, such as emotions, expert testimony, and explanations by expert members, are used. As such, the Law respects the autonomy of medical care even in the establishment of norms and the application of norms. In particular, Clinical practice guidelines prepared independently by the medical community are referred to in establishing norms, which are the prerequisites for legal syllogism. This shows that doctors participate in the formation of precedents and contribute to the formation of norms. The use of clinical practice guidelines in trials is respect and consideration for the autonomy of medical care. Although there may be an aspect in which the autonomy of individual doctors is limited by clinical practice guidelines, it should be considered that the autonomy of doctors as a group is respected. In this way, the clinical practice guidelines play a role in protecting the autonomy of the "medical" group from the logic of the "law."

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Korean Journal of Clinical Pharmacy
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• v.25 no.3
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• pp.200-208
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• 2015

Objective: Patients with acute coronary syndrome (ACS) are typically managed with dual antiplatelet therapy of acetylsalicylic acid (aspirin) and $P2Y_{12}$ receptor inhibitor. In this study, we discussed current and previous antiplatelet therapy guidelines and compared with guidelines of the USA (ACC/AHA), Europe (ESC) and Korea (KSC). Method: This study investigated from ACC/AHA Joint Guidelines (the USA), ESC Clinical Practice Guidelines (Europe) and Korea Society of Interventional Cardiology (Korea) web site, respectively. Results: It is significant that difference between the current and the previous guidelines was integration of terminology from clopidogrel to $P2Y_{12}$ receptor inhibitors since prasugrel and ticagrelor, new antiplatelet drugs, has been added. The other difference was all three guidelines has differences in dose of aspirin. The most notable difference was class of recommendation(COR) in $P2Y_{12}$ receptor inhibitors. ACC/AHA and Korean guidelines recommend clopidogrel, prasugrel, and ticagrelor with COR IB; whereas, ESC recommend prasugrel and ticagrelor with IB which is higher than clopidogrel with IC. Conclusion: This research addresses important movement to revise the Korean existing guideline recommendations. New Korean antiplatelet therapy guideline should be avoiding obvious differences in ACC/AHA and ESC guidelines and harmonizing international guidelines.

• Journal of Korean Clinical Nursing Research
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• v.15 no.1
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• pp.133-147
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• 2009

Purpose: This study was conducted to construct evidence based clinical guidelines and to develop nursing process based performance measures for prevention and management of pressure ulcers, falls and pain. Method: Clinical guidelines were drafted through a comprehensive review of relevant literature, national guidelines and hospital protocols. The proposed guidelines were reviewed by a panel of experts and 90 hospital nurses, and refined on the basis of their suggestions. Nursing process based performance measures were developed based on the clinical guidelines and content validity was examined by surveys from 90 hospital nurses. Results: All items, except timetable for position change and pressure ulcer nursing record, in the guidelines for prevention and management of pressure ulcer were appropriate. Most items, except fall risk assessment tools, were appropriate for the guidelines of fall prevention. All other items, except the purpose of pain management, were appropriate for the guidelines of pain management. Performance measures developed in this study were acceptable as a tool to evaluate quality of nursing care. Conclusion: Nursing process based performance measures provide important indicators to monitor whether necessary nursing care is implemented and can be used as the primary resources to improve quality of nursing services.

• The Journal of Internal Korean Medicine
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• v.33 no.4
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• pp.347-366
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• 2012

The aim of this new statement is to provide comprehensive and timely evidence-based recommendations on stroke management for clinical practitioners. Many countries are already well engaged in developing and releasing their own clinical practice guidelines, whereas Korean Medicine (KM) is still beginning. It will take time and effort to develop evidence-based guidelines and recommendations of KM or other traditional medicine because they are weak in the area of scientific evidence. The clinical practice guideline of Korean medicine for stroke was formulated through extensive review of published literature and consensus meeting of Korean medicine specialists. This project was supported by a grant of the Oriental Medicine R&D Project, the Ministry of Health and Welfare. Referring to guidelines developed in other countries, the experts in the subject tried to organize and develop guidelines and recommendations adequate for domestic medical circumstances. In December, 2008, a multi-disciplinary team called the Evidence Based Clinical Practice Guidelines Development Group (EBCPGsDG) for Stroke was organized. The writing committee was comprised of experts in internal medicine, acupuncture, rehabilitation, and Sasang constitution. Outside specialists and associated panels were invited for consultation. The scope of the guideline encompasses acupuncture, moxibustion and herbal medicine (including Korean medicine, traditional Chinese medicine, Kampo medicine) as interventions for stroke patients. It includes statements about ischemic stroke (I63), stroke not specified as hemorrhage or infarction (I64), and sequelae of cerebrovascular disease (I69) according to the International Classification of Disease (ICD). The committee subdivided the description of herbal medications into acute stroke management, subacute stroke management, post-stroke management, and secondary prevention of stroke. Guidelines on the practice of acupuncture and moxibustion were described in order for acute stroke management, subacute stroke management, chronic stroke management, and post-stroke rehabilitation. Clinicians who are working in the field of stroke care can adopt this guideline for their practice.