• Quality Improvement in Health Care
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• v.2 no.1
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• Advances in pediatric surgery
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• v.4 no.2
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• pp.117-124
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• 1998

The embryological and anatomical features of urachal anomalies have been well defined. Because of the variable clinical presentation, uniform guideline for evaluation and treatment are lacking. Although urachal remnants are rarely observed clinically, they often give rise to a number of problems such as infection and late malignant changes. Therefore, a total assessment of the disease with a particular focus on embryology, anatomy, clinical symptoms, as well as the most advisable management, is necessary. Twenty six patients with urachal remnants were treated at the Department of Pediatric Surgery from August 1980 to June 1998. Of these 26, 9 were classified as patent urachus 11 as urachal sinus, 4 as urachal cyst, 1 as urachal diverticulum and 1 as an alternating sinus. The group consisted of 11 males and 15 females. The age distribution was 20 neonates, 3 infants, 2 preschoolers and 1 adult. Infection was the most frequent complication and Staph. aureus was the predominant causative microorganism. Fistulogram was performed in 4 cases and ultrasound examination disclosed cysts or sinus in 7 cases. Excision was performed in 24 patients and incision and draniage in 2 cases as a primary treatment. There was no postopreative complication or recurrence.

• Toxicological Research
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• v.25 no.1
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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.

• The Journal of Korean society of community based occupational therapy
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• v.10 no.2
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• pp.1-9
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• 2020

Objective : The purpose of this study was to establish the concurrent validity of the Korean Occupational Balance Assessment(OBA) tool. Methods : This study was conducted on 1016 people from October 1 to October 25, 2019. Data collection was performed using OBA and Occupational Balance Questionnaire11(OBQ11). The data were analyzed by descriptive statistics, Pearson correlation. Results : There was a significant correlation between the scores of the three areas of OBA and the total score of OBQ11(p<.01). All three areas were analyzed with positive correlations. The time use area (r = .554) and occupation frequency area (r = .574) were found to be correlated. Most of the sub-factors in the occupation characteristics area (importance r = .582, goal achievement r = .633, enjoyment r = .649, health r = .650) were analyzed with high correlation. Conclusion : OBA has proven to be a valid and reliable assessment tool for measuring occupational balance. Further research needs to provide guideline on occupational balance for usefulness in clinical area.

• Quality Improvement in Health Care
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• v.3 no.1
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• pp.126-143
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• 1996

Background : Little work has been carried out regarding quality assessment research in a primary care setting, comparing with that of hospitals. This study aims to evaluate the process of diagnosis and management of hypertension by public health doctors on the basis of pre-established clinical guideline, and to identify several modifying factors associated with them. Methods : Hypertension was selected as the target disease, because it is a chronic disease which is of great public health importance. Self-administered questionnaires were mailed to public health doctors practicing at health centers and health subcenters across the nation. The response rate was 20.9%. The questionnaire included the diagnosis and management process such as measuring blood pressure, history taking, physical examinations, and treatment approches and potentially modifying factors such as level of training, duration of practice as a public health doctor, and education on management of hypertension. Results : Public health doctors pay little attention in measuring BP, hypertension related history taking, performing physical examination and laboratory examination. But they devoted much effort in diagnosing hypertension exactly and giving nonpharmacological treatment. Among various antihypertensive drugs, calcium-channel blockers were the most preferred agent(50.9%). Level of training, duration of practice ad a public health doctor, and education on management of hypertension made no difference on quality of care(p>0.05). Conclusion : These public health doctors showed poor compliance with the pre-established clinical guidelines, which leaves much to be desired in diagnosing and managing hypertensive patients by public health doctors. This study might be able to contribute to develop some strategies, such as educational programs, which would be able to improve the process of care in hypertensives.

• Journal of Acupuncture Research
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• v.39 no.4
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• pp.249-257
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• 2022

This study aimed to evaluate clinical practice guidelines (CPGs) for ankle sprains using the Appraisal of Guidelines for Research and Evaluation II tool, using electronic databases (GIN, PubMed, EMBASE, NCKM, CNKI, CiNii, WanFang database, RISS, and SCOPUS), to suggest strategies for improvement in the future. The search was performed on April 23, 2021 and 10 CPGs were selected for evaluation. Three CPGs were recommended without modification (Class A scores), five were recommended with modification (Class B), and two were not recommended (Class C scores). The CPG domain that received the lowest score was "applicability." The traditional medicine CPGs scored higher [Class A (n = 1) and Class B (n = 1)] than the conventional Western medicine CPGs [Class A (n = 2), Class B (n = 4), and Class C (n = 2)] and were considered to be more methodical. In the future, more research into traditional medicine is required.

• The Korea Journal of Herbology
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• v.33 no.4
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• pp.53-58
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• 2018

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications. Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 mg/kg to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety). Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 mg/kg and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• Journal of Oriental Neuropsychiatry
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• v.24 no.3
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• pp.201-210
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• 2013

Objectives : To review the recent trend of randomized controlled clinical trials on insomnia and to provide information for future clinical trials. Methods : A total of 667 pieces of literature were searched using the key words 'insomnia' and 'randomized controlled trial' and using the title 'insomnia' with the topic 'trial or trials', published from 2008 to 2012 through Web of Science. Studies including randomized controlled clinical trials were sorted from the search result and finally 104 pieces of the literature were selected and examined. Results : Besides 104 clinical trials, 14 trials related to CAM (Complementary and Alternative Medicine) were also reviewed. On average, 20 trials were annually conducted and they showed a growing trend. Participants were between 31 and 90 (34.6%), and were observed for less than 30 days (28.8%) in most trials. As intervention methods for clinical trials, non-pharmaceutical methods were used in 59 studies (56.7%), pharmaceutical drug in 43 studies (41.3%) and combinations in 2 studies (1.9%). In 60 studies, only insomnia without any underlying diseases was examined and other 44 studies involved other diseases. As diagnosis assessment tools, Sleep diary and Polysomnography were used. Conclusions : Randomized controlled trials relevant to insomnia were on the increase, but only a small number of clinical trials on Oriental Medicine have been performed. Larger scientific and well-founded randomized controlled trials are required for developing Oriental Medicine and establishing high-quality guideline going forward.

• Korean Journal of Clinical Pharmacy
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• v.29 no.3
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• pp.193-201
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• 2019

Background and Objective: Since the introduction of hospital pharmacy residency programs in 1983, hospital pharmacists in South Korea have been expected to expand their roles. However, their services and the outcomes have not been fully understood. In this study, we conducted a systematic review of Korean hospital pharmacist-provided interventions with regard to intervention type, intervention consequences, and target patient groups. Methods: A literature search of the following databases was performed: Embase, PubMed, Medline, KoreaMed, RISS, KMbase, KISS, NDSL, and KISTI. The search words were "hospital pharmacist", "clinical pharmacist", and "Korea". Articles reporting clinical or economic outcome measures that resulted from hospital pharmacist interventions were considered. Numeric measures for the acceptance rate of pharmacist recommendations were subjected to meta-analysis. Results: Of the 1,683 articles searched, 44 met the inclusion selection criteria. Most articles were published after 2000 (81.8%) and focused on clinical outcomes. Economic outcomes had been published since 2011. The interventions were classified as patient education, multidisciplinary team work, medication assessment, and guideline development. The outcome measures were physicians' prescription changes, clinical outcomes, patient adherence, economic outcomes, and quality of life. The acceptance rate was 80.5% (p < 0.005). Conclusion: Studies on pharmacist interventions have increased and showed increased patient health benefits and reduced medical costs at Korean hospital sites. Because pharmacists' professional competency would be recognized if the economic outcomes of their work were confirmed and justified, studies on their clinical performance should also include their economic impact.

• Korean Journal of Clinical Pharmacy
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• v.25 no.4
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• pp.246-253
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• 2015

Background & Object: Ankylosing spondylitis (AS) is a chronic inflammatory disease that causes ankylosis and deformation of axial joints. Since current medicine cannot cure the disease yet, alleviating pain and preventing deformation with medications are the main therapy for patients with AS. The key medications for these purposes include nonsteroidal anti-inflammatory drugs (NSAIDs), and tumor necrosis $factor-{\alpha}$ ($TNF-{\alpha}$) inhibitors. This study aims to analyze prescribing patterns of AS patients in South Korea. Method: National Patients Sample data compiled by the Health Insurance Review and Assessment Service from 2013 was analyzed. Patients with AS were identified with Korean Standard Classification of Diseases code-6, which was M45. The rates of prescription, discontinuation, and switching ingredients were calculated for each medication during 2013. Results: Total number of patients was 655, and most of them were male (n = 514, 78.5%). Of all age groups, the proportion of 30-40 year old patients was the greatest (35.1%). The most utilized drug class was NSAIDs (82.4%). Less than half of patients were prescribed $TNF-{\alpha}$ inhibitors (n = 212, 32.4%). Meloxicam, aceclofenac, and celecoxib were the most frequently prescribed NSAIDs. In case of $TNF-{\alpha}$ inhibitors, adalimumab, etanercept and infliximab were the top three most prescribed drugs. Although not recommended by the current practice guideline, significant proportions of patients were identified using disease modifying anti-rheumatic drugs (DMARDs). Conclusion: Considering the current practice guideline and previous studies about the efficacy, the use of DMARDs should be reduced and medical insurance term in South Korea should be re-examined.