• The Journal of Korean Medicine
• /
• v.44 no.1
• /
• pp.128-128
• /
• 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
• /
• v.37 no.3
• /
• pp.516-528
• /
• 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
• /
• v.26 no.2
• /
• pp.181-186
• /
• 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
• /
• v.28 no.1
• /
• pp.51-61
• /
• 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.

• Childhood Kidney Diseases
• /
• v.19 no.2
• /
• pp.56-64
• /
• 2015

To revise the clinical guideline for childhood urinary tract infections (UTIs) of the Korean Society of Pediatric Nephrology (2007), the recently updated guidelines and new data were reviewed. The major revisions are as follows. In diagnosis, the criterion for a positive culture of the catheterized or suprapubic aspirated urine is reduced to 50,000 colony forming uits (CFUs)/mL from 100,000 CFU/mL. Diagnosis is more confirmatory if the urinalysis is abnormal. In treating febrile UTI and pyelonephritis, oral antibiotics is considered to be as effective as parenteral antibiotics. In urologic imaging studies, the traditional aggressive approach to find primary vesicoureteral reflux (VUR) and renal scar is shifted to the targeted restrictive approach. A voiding cystourethrography is not routinely recommended and is indicated only in atypical or complex clinical conditions, abnormal ultrasonography and recurrent UTIs. $^{99m}Tc$-DMSA renal scan is valuable in diagnosing pyelonephritis in children with negative culture or normal RBUS. Although it is not routinely recommended, normal scan can safely avoid VCUG. In prevention, a more natural approach is preferred. Antimicrobial prophylaxis is not supported any more even in children with VUR. Topical steroid (2-4 weeks) to non-retractile physiologic phimosis or labial adhesion is a reasonable first-line treatment. Urogenital hygiene is important and must be adequately performed. Breast milk, probiotics and cranberries are dietary factors to prevent UTIs. Voiding dysfunction and constipation should be properly treated and prevented by initiating toilet training at an appropriate age (18-24 months). The follow-up urine test on subsequent unexplained febrile illness is strongly recommended. Changes of this revision is not exclusive and appropriate variation still may be accepted.

• Korean Journal of Biological Psychiatry
• /
• v.14 no.1
• /
• pp.21-27
• /
• 2007

Objectives : As a part of plan to develop evidence-based treatment guidelines for depression that is more suitable for Korean situation, we investigate the present status and client's requirements for non-pharmacological treatment of depression in Korean clinical situation. Methods : Subjects were patients with depression in 12 university hospitals which are located in metropolises in Korea. We analyzed the records from questionnaires about current clinical status and requirements for the non-pharmacological treatment of depression in Korea. Results : 50.8% of the subjects have experienced non-pharmacological treatments for their depression. The preference of non-pharmacological treatment method of depression is exercise/interesting activity, counseling by psychiatrists and psychotherapy, and the best effective treatment method is psychotherapy (Es=4.36). Actually, the mean consultation time by psychiatrist is $11.31{\pm}7.16$ min, and the appropriate consultation time for client's situation is $18.39{\pm}8.95$ min. During consultation, patients' satisfaction measurement for psychiatrist's explanation about pharmacological treatment is $64.17{\pm}27.11$, and satisfaction measurement for psychiatrist's counseling for their depression about personal problems, resent stress, interpersonal relationship is $61.66{\pm}26.63$. Conclusion : In Korea, many psychiatrists offered biologically oriented treatment to their patients with depression, and patients' satisfaction measurement about consultation by psychiatrists is low. Many patients wanted to combined pharmacological and non-pharmacological treatment for their depression, and aspired to information about complementary and self-help treatment methods. It is necessary to develop non-pharmacological treatment guideline for depression which reflect the clinical situation in Korea and meet Korean patients' need.

• Quality Improvement in Health Care
• /
• v.5 no.1
• /
• pp.152-165
• /
• 1998

Background : In this paper patient outcomes research is going to be reviewed and described, to be compared with relevant studies, and to consider the application in Korea. Methods : We compiled and reviewed the articles and materials related to patient outcomes research especially by PORT(Patient Outcomes Research Team) and rearranged them for seeking the main point and comparing with relevant studies. Results : Patient outcomes research emphasizes patient outcomes as well as conventional clinical outcomes. It is prospective study observing effectiveness in real situation instead of efficacy in ideal condition. Patient outcomes research comprises of 6 fields ; literature review and meta-analysis, use of claims data, decision modeling, outcomes assessment, cost of care, dissemination of research findings. SAA(small-area variations analysis), appropriateness study and clinical practice guideline are connected with patient outcomes research. Conclusion : In view of the fact that current medical policy in Korea is shifting its focus from accessibility to the improvement in quality and cost containment, and is stressing patient-based research, patient outcomes research is one direction for which the medicine is accountable and assessable. Considering that the number of patient receiving medical treatment in Korea is higher than the West, patient outcomes research has competitive power as against the West.

• Journal of Ginseng Research
• /
• v.46 no.1
• /
• pp.71-78
• /
• 2022

Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

• Tuberculosis and Respiratory Diseases
• /
• v.85 no.1
• /
• pp.1-10
• /
• 2022

Pulmonary hypertension (PH) is a condition of increased blood pressure in the pulmonary arteries and is diagnosed with an increased a mean pulmonary artery pressure ≥25 mm Hg. This condition may be associated with multiple clinical situations. Based on pathophysiological mechanisms, clinical presentation, hemodynamic profiles, and treatment strategies, the patients were classified into five clinical groups. Although there have been major advances in the management of PH, it is still associated with significant morbidity and mortality. The diagnosis and treatment of PH have been performed mainly by following European guidelines, even in Korea because the country lacks localized PH guidelines. European treatment guidelines do not reflect the actual status of Korea. Therefore, the European diagnosis and treatment of PH have not been tailored well to suit the needs of Korean patients with PH. To address this issue, we developed this guideline to facilitate the diagnosis and treatment of PH appropriately in Korea, a country where the consensus for the diagnosis and treatment of PH remains insufficient. This is the first edition of the guidelines for the diagnosis and treatment of PH in Korea, and it is primarily based on the '2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.' with the acceptance and adaptation of recent publications of PH.

• Clinical Nutrition Research
• /
• v.11 no.1
• /
• pp.9-19
• /
• 2022

This study was conducted to analyze the status of medical food selection process in hospitals within Busan and Gyeongnam area. The survey was distributed to 396 hospitals (general, tertiary and long-term care hospitals) and finally 68 surveys were used for analysis. The questionnaire consisted of 9 general items and 10 items related to enteral nutrition (EN). From the survey we found out that general hospitals and tertiary hospitals normally hire clinical dietitian, while long-term care hospitals hire dietitians with no further qualifications (χ² = 27.918, p < 0.001). A significant relationship was found between hospital size and the priority for choosing medical foods for patients (χ² = 11.852, p < 0.05). In general and tertiary hospitals, medical foods were provided exactly according to the doctor's prescription, whereas in long-term care hospitals, only half followed the doctor's direction and half of them provided the products that has been conventionally used. There was also a significant relationship between hospital size and the method for determination of nutrition requirements (χ² = 20.496, p < 0.001). Finally, the priority of considerations when developing a 'medical food guidelines' was shown in the following order; 1) the type of medical food that can be selected according to the disease state, 2) the nutrient content and comparison table for commercial products, and 3) how to manage complications that may occur when supplying medical food for patients. Developing an EN practice guideline for making a sensible selection of medical foods will provide a valuable information for better patient care.