• Translational and Clinical Pharmacology
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• 제26권4호
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• 대한한의학회지
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• 제43권1호
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• pp.154-170
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• 2022

Objectives: The purpose of this study was review the current clinical studies about the effect of Korean traditional medicine treatment for meniscus injury. Methods: Clinical studies on Korean traditional medicine treatment of meniscus injury were searched through 11 online databases. We analyzed the authors, publication year, country, study design, subjects, treatment methods, treatment effects, evaluation tools and adverse events of the selected studies. Results: 23 studies which included 9 randomized controlled trials, 8 case reports, 4 retrospective observational studies, 2 non-randomized controlled trials were selected through the databases. A total of 9 Korean traditional medicine treatments were used, among them, acupuncture treatment was the most used. The most commonly used outcome was effective rate. Conclusions: Through this study, we could confirm that Korean traditional medicine is an effective treatment for meniscus injury. It was suggested that various clinical studies on the effects of Korean traditional medicine for meniscus injury are needed and it is necessary to establish more scientific evidence through studies with a high level of evidence.

• 대한간호학회지
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• 제41권6호
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• pp.768-779
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• 2011

Purpose: This study was designed to adapt a surgical wound care algorithm that is used to provide evidence-based surgical wound care in a critical care unit. Methods: This study used, the 'ADAPTE process', an international clinical practice guideline development method. The -'Bonnie Sue wound care algorithm' - was used as a draft for the new algorithm. A content validity index (CVI) targeting 135 critical care nurses was conducted. A 5-point Likert scale was applied to the CVI test using a statistical criterion of .75. Results: A surgical wound care algorithm comprised 9 components: wound assessment, infection control, necrotic tissue management, wound classification by exudates and depths, dressing selection, consideration of systemic factors, wound expected outcome, reevaluate non-healing wounds, and special treatment for non-healing wounds. All of the CVI tests were ${\leq}$.75. Compared to existing wound care guidelines, the new wound care algorithm provides precise wound assessment, reliabilities of wound care, expands applicability of wound care to critically ill patients, and provides evidence and strength of recommendations. Conclusion: The new surgical wound care algorithm will contribute to the advancement of evidence-based nursing care, and its use is expected as a nursing intervention in critical care.

• 가정∙방문간호학회지
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• 제29권1호
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• pp.31-39
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• 2022

Purpose: This study investigated the effects of evidence-based practice competency, self-leadership, and organizational commitment on professional self-concept of nurses in regional trauma centers. Methods: The 98 research participants were nurses with clinical experience of a year or more. Descriptive statistics, t-tests, Mann-Whitney U test, ANOVA, and Pearson's correlation coefficients were computed, and multiple regression analysis was conducted. Results: Professional self-concept showed statistically significant differences according to marital status, religion, and educational background, and was positively correlated with and affected by evidence-based practice competency, self-leadership, and organizational commitment. Conclusion: Trauma nursing education programs should include evidence-based practice competency and self-leadership and organizational support should be provided to improve the professional self-concept of nurses in regional trauma centers.

• Korean Journal of Acupuncture
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• 제28권3호
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• pp.99-111
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• 2011

Objectives : The aim of this study is to estimate traditional Korean medicine (TKM) practitioners' awareness and attitudes about acupuncture clinical study toward evidence based medicine (EBM). Methods : We conducted two surveys before and after the workshop. First survey, about the awareness and attitudes toward EBM was carried out with questionnaire. Second survey, about their changes in the attitudes toward EBM after the workshop was carried out with on-line questionnaire. Results : 70.0 % of respondents shows interest in the trends of clinical research. In contrast, 26.0 % of respondents used to search papers by themselves. 30.3 % of respondents reported that they apply the result of researches to their practice. 41.0 % of respondents thought that case study is needed for their practice, whereas 29.5 % responded that randomized controlled trial is most important. In the second survey, the attitudes toward EBM were changes positive. fair number of respondents usually get information from data regardless of EBM for their practice, but 23.5 % of respondents refer to the journals. Conclusions : The awareness and needs for education on the attendees toward EBM is quite high, and the effect of education is possibly influential. We expect the improvement on the refresher and the extension of education course for practitioners, and undergraduate curriculum.

• 한국임상보건과학회지
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• 제5권4호
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• pp.1009-1014
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• 2017

Purpose. This study compared the awareness of the evidence-based practice(EBP) in 100 physical and occupational therapists. Methods. A questionnaire on awareness was conducted to examine the attitude toward EBP, the educational experience of EBP, and the performance ability of EBP. A questionnaire consisted of items on the general characteristics, the attitude toward EBP, the educational experience of EBP, and the performance ability of EBP of the subjects. Data analysis was made by IBM SPSS Statistics Ver. 20. The EBP awareness was examined by the independent t-test. Results. For the attitude toward EBP, there was a statistically significant difference in the item of 'Therapists should judge whether they apply study results to individual patient. For the educational experience of EBP, there was no statistically significant difference in all items. For the performance ability of EBP, there was a statistically significant difference in the item about the ability to understand patient's desire for treatment and treatment preference and the item about the ability to determine appropriate treatment process in cooperation with patients. Conclusions. Both two groups showed very low results in the attitude toward EBP, the educational experience of EBP, and the performance ability of EBP. Therefore, it is necessary to enhance EBP education in undergraduate programs and the clinical field.

• 임상간호연구
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• 제26권2호
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• pp.141-153
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• 2020

Purpose: This study aimed to update the previously published nursing practice guideline for oral care. Methods: The guideline were updated according to the manuals developed by National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN), and a Handbook for Clinical Practice Guideline Developer Version 1.0. Results: Updated nursing practice guideline for oral care was consisted of 10 domains and 79 recommendations. The number of recommendations in each domain were: 5 general issues, 2 oral care indications, 9 oral assessment, 16 general oral care, 12 oral care for critically ill patients, 16 oral care for cancer patients, 12 oral care for cancer patients with oral complications, 5 oral care education, 1 oral care referral, and 1 documentation and report. In terms of grades for recommendations, 11.4% was grade A, 17.0% was grade B, and 68.2% was grade C. Twelve new recommendations were developed and 7 previous recommendations were deleted. Conclusion: Updated nursing practice guideline for oral care is expected to serve as an evidence-based practice guideline for oral care in South Korea. It is recommended that this guideline be spread to clinical nursing settings nationwide to improve the effectiveness of oral care practice.

• 대한물리치료과학회지
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• 제28권1호
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• pp.33-45
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• 2021

Background: Children with cerebral palsy have difficulty acquiring motor skills through motor learning due to lack of motor planning of the central nervous system and musculoskeletal dysfunction. Motor learning is the acquisition or modification of movements with the aim of developing skilled movements and behaviors. Cerebral palsy improve motor function through motor learning, and effective motor learning mainly depends on practice parameters such as learning feedback. Therefore, we investigate the effect of motor learning in children with cerebral palsy and try to present the possibility of clinical application. Design: A systemic review. Methods: Research papers were published from Jan, 2010 to Dec, 2020 and were searched using PubMed and Medline. The search terms are 'task specific training' OR 'motor learning' OR 'feedback(Mesh term)' OR 'goal activity' AND 'cerebral palsy(Mesh term)'. A total of eight papers were analyzed in this study. The paper presented the quality level based on the research evidence, and also presented PEDro (Physiotherapy Evidence Database) scores to evaluate the quality of design studies in randomized clinical trials. Results: The results showed that motor learning coaching in children with cerebral palsy improved motor function in post and follow up tests. Also, self-control feedback of motor learning is more effective than external control feedback. 100% external control feedback of motor learning is effective in the acquisition phase and 50% external feedback of motor learning is effective in the retain phase. Conclusion: These results suggest that it will be an important data for establishing evidence on the effect of motor learning arbitration methods in children with cerebral palsy to develop clinical applicability and protocols.

• The Korean Journal of Pain
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• 제34권3호
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• pp.271-287
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• 2021

Background: Postoperative pain management is crucial for patients undergoing total knee arthroplasty (TKA). There have been many recent clinical trials on post-TKA peripheral nerve block; however, they have reported inconsistent findings. In this meta-analysis, we aimed to comprehensively analyze studies on post-TKA analgesia to provide evidence-based clinical suggestions. Methods: We performed a computer-based query of PubMed, Embase, the Cochrane Library, and the Web of Science to retrieve related articles using neurothe following search terms: nerve block, nerve blockade, chemodenervation, chemical neurolysis, peridural block, epidural anesthesia, extradural anesthesia, total knee arthroplasty, total knee replacement, partial knee replacement, and others. After quality evaluation and data extraction, we analyzed the complications, visual analogue scale (VAS) score, patient satisfaction, perioperative opioid dosage, and rehabilitation indices. Evidence was rated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: We included 16 randomized controlled trials involving 981 patients (511 receiving peripheral nerve block and 470 receiving epidural block) in the final analysis. Compared with an epidural block, a peripheral nerve block significantly reduced complications. There were no significant between-group differences in the postoperative VAS score, patient satisfaction, perioperative opioid dosage, and rehabilitation indices. Conclusions: Our findings demonstrate that the peripheral nerve block is superior to the epidural block in reducing complications without compromising the analgesic effect and patient satisfaction. Therefore, a peripheral nerve block is a safe and effective postoperative analgesic method with encouraging clinical prospects.

• 동서간호학연구지
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• 제28권2호
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• pp.100-108
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• 2022

Korean medicine has traditionally provided a lot of medical care for the treatment of infertility. The combination treatment of Korean medicine and Western medicine can be effective for infertility to improve the problems caused by the extremely low fertility rate and the aging of pregnant women. In relation to female infertility, we reviewed the evidence for Korean medicine treatment for polycystic ovary syndrome, which has recently been increasing interest in female infertility, and the evidence for the collaboration between Korean and Western medicine in the treatment of polycystic ovary syndrome and infertility. Because polycystic ovary syndrome is closely related to metabolic diseases related to endocrine abnormalities, hormone treatment alone has limited therapeutic effects and has side effects. In domestic and international research, herbal medicine and acupuncture in the treatment of infertility have shown good clinical effects based on the hypothesis of various mechanisms of effect, and many cases of successful pregnancy have been reported. Although continuous research through large-scale randomized clinical studies is needed to prove efficacy, the importance of combined treatment of Korean medicine and Western medicine in infertility treatment is increasing in order to solve the extremely low fertility rate. Combining artificial insemination or in vitro fertilization with Korean medicine treatment is highly likely to be effective in increasing pregnancy success and fertility rates. In women with polycystic ovary syndrome, which is recognized as a metabolic disease due to endocrine abnormalities among the causes of female infertility, Korean medicine treatment can increase the pregnancy rate with herbal medicines and acupuncture, etc. Although well-designed large-scale clinical studies are currently lacking and meta-analysis has not provided sufficient evidence, the combination treatment of Korean medicine and Western medicine is more active to increase the pregnancy rate for solving the problem of low fertility.