• Title/Summary/Keyword: pragmatic trial

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Review of the Large-Scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC (2000년부터 독일에서 수행된 대규모 침 임상연구들에 대한 고찰: ASH, ART, ARC, GERAC)

  • Yoon, Juyeon;Han, Kuk-In;Jeong, Jinsu;Lee, Seungho;Jang, Insoo
    • Korean Journal of Acupuncture
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    • v.30 no.1
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    • pp.21-26
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    • 2013
  • Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

Clinical research methodology for Traditional Korean Medicine treatment of lung cancer : Evidence-based approach (폐암(肺癌)의 한방치료 임상연구 방법론)

  • Kim, Kyung-Suk;Kim, Sme-Hyun;Eo, Wan-Kyu;Cheon, Seong-Ha;Eom, Seok-Ki;Jo, Hak-Jun
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.39-62
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    • 2010
  • Background : I investigated clinical research methodology of Traditional Korean Medicine(TKM) for treatment of lung cancer with Evidence Based Medicine(EBM) approach. Methods : I conducted the internet search of National Central Library, the National Assembly Library, Korea Education & Research Information Service, Korea Institute of Science and Technology Information for Korean theses and papers, and MEDLINE for the outside articles. Conclusion : In addition to outcomes of clinical trial, abundant clinician's experience and patients' preference are also considered. Pragmatic trials and quasi-experimental trials are better than clinical trials to plan clinical design of TKM for lung cancer and appropriate endpoints includes overall survival, disease-free survival, patient reporting outcome.

Study on the Proposals for Clinical Research in Korean Medicine Worldwide - Future Clinical Research Strategy II - (한의 임상 연구에 대한 국내외 제언 고찰 - 미래 임상 연구 전략 II -)

  • Jung, Ki Yong;Lee, Min Hye;Choi, You Kyung;Lee, Choong Yeol;Park, Jong Hyeong;Jeon, Chan Yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.29 no.2
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    • pp.115-126
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    • 2015
  • The purpose of this paper is to explore the strategy of future Korean medicine(KM) clinical research through the study on the proposals for KM clinical research worldwide. In this study, the papers published in English through Pubmed were investigated mainly. Among them, we analyzed the methodological proposals from the clinical research papers that were published in the KM related fields. Various proposals for improving the problems in KM clinical studies are as follows. First, KM clinical research should be designed based on understanding for the theory, backgrounds, paradigms and worldviews of KM. In addition, considering the model validity, KM clinical research model should include the diagnosis, interventions and outcomes measurement methods reflecting the characteristics and real practice in KM. The internal validity and external validity should be also taken into account. One of the most important thing is to identify the contents about various and complex 'real practice' in KM. A prospective observational study was suitable for the purpose of this study. Finally, we suggested a few improvement directions for RCTs studies in KM. First, we would be able to improve the quality and the internal validity in KM clinical research using the checklists of CONSORT(Consolidated Standards for Reporting Trials) Statement and STRICTA(Standards for Reporting Interventions in Clinical Trials of Acupuncture). Second, we could use various clinical research methods and the modified research of RCTs such as PCT(pragmatic clinical trial) to reflect the characteristics of actual KM practice. Consequently, we would be able to improve the external validity. Third, the KM diagnosis and outcomes measurement methods should be developed based on an actual KM practice and it should reflect a real practice. The 'pattern identification(辨證)' is the core to KM diagnosis. But in order to be applied to the clinical research, the pattern identification(辨證) should be objectified and standardized. Future KM clinical research model should reflect the characteristics and a real practice in KM. In addition, it should include the advantage of rigorous RCTs research.Specially, the diagnosis, interventions and outcomes measurement methods in KM clinical research should reflect this view.

Evaluating the Effectiveness of Chuna Manual Therapy for low back pain in the Pilot Insuring Project of the National Health Insurance (건강보험 시범사업 기관에 내원한 요통환자에 대한 추나요법 유효성 평가 연구)

  • Ryu, Jiseon;Kim, Dongsu;Shin, Byung-Cheul;Lim, Byungmook
    • Journal of Society of Preventive Korean Medicine
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    • v.22 no.3
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    • pp.1-10
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    • 2018
  • Backgrounds : In 2017, National Health Insurance implemented the pilot insuring project for Chuna manual therapy(CMT). 65 Korean Medicine(KM) hospitals and clinics were selected in the project to monitor the provision of insured CMT. Objectives : This study aimed to evaluate the effectiveness of CMT for low back pain provided in the real world setting. Methods : Patients with low back pain who agreed to participated in the study were enrolled and requested to complete questionnaires. Patients who received CMT regardless of receiving other KM therapies were classified to Chuna group, and patient who received KM therapies without CMT to KM group. Pain(pain-VAS) and back function(KODI, Oswestry disability index-Korean version), quality of life were assessed at baseline, 4 weeks, and 8 weeks. Additionally, patients who received CMT twice and more, and who's pain-VAS 20 and over were included, and patients who used pain injection were excluded in the analysis. Results : Of 371 patients who completed all questionnaire (mean age=42.6years, SD=12.45; 61% female), 96 were excluded, 170 were in Chuna group, and 105 were in KM group. Proportions of patients who had low back pain for more than twelve weeks in the Chuna group and KM group were 57.7% and 24.8%, respectively. Pain and back function were significantly improved on 4weeks and 8weeks in both groups, but there was no difference between two groups. For the patients in the sub-acute and chronic stage(>=12 weeks), change of total KODI scores in the Chuna group was higher than KM group(p=0.013) at 4weeks. Conclusions : CMT with other KM therapies can improve back function in the sub-acute and chronic patients. For insurance policy decision, economic evaluation of CMT is needed.

Appendiceal Visualization on 2-mSv CT vs. Conventional-Dose CT in Adolescents and Young Adults with Suspected Appendicitis: An Analysis of Large Pragmatic Randomized Trial Data

  • Jungheum Cho;Youngjune Kim;Seungjae Lee;Hooney Daniel Min;Yousun Ko;Choong Guen Chee;Hae Young Kim;Ji Hoon Park;Kyoung Ho Lee;LOCAT Group
    • Korean Journal of Radiology
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    • v.23 no.4
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    • pp.413-425
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    • 2022
  • Objective: We compared appendiceal visualization on 2-mSv CT vs. conventional-dose CT (median 7 mSv) in adolescents and young adults and analyzed the undesirable clinical and diagnostic outcomes that followed appendiceal nonvisualization. Materials and Methods: A total of 3074 patients aged 15-44 years (mean ± standard deviation, 28 ± 9 years; 1672 female) from 20 hospitals were randomized to the 2-mSv CT or conventional-dose CT group (1535 vs. 1539) from December 2013 through August 2016. A total of 161 radiologists from 20 institutions prospectively rated appendiceal visualization (grade 0, not identified; grade 1, unsure or partly visualized; and grade 2, clearly and entirely visualized) and the presence of appendicitis in these patients. The final diagnosis was based on CT imaging and surgical, pathologic, and clinical findings. We analyzed undesirable clinical or diagnostic outcomes, such as negative appendectomy, perforated appendicitis, more extensive than simple appendectomy, delay in patient management, or incorrect CT diagnosis, which followed appendiceal nonvisualization (defined as grade 0 or 1) and compared the outcomes between the two groups. Results: In the 2-mSv CT and conventional-dose CT groups, appendiceal visualization was rated as grade 0 in 41 (2.7%) and 18 (1.2%) patients, respectively; grade 1 in 181 (11.8%) and 81 (5.3%) patients, respectively; and grade 2 in 1304 (85.0%) and 1421 (92.3%) patients, respectively (p < 0.001). Overall, undesirable outcomes were rare in both groups. Compared to the conventional-dose CT group, the 2-mSv CT group had slightly higher rates of perforated appendicitis (1.1% [17] vs. 0.5% [7], p = 0.06) and false-negative diagnoses (0.4% [6] vs. 0.0% [0], p = 0.01) following appendiceal nonvisualization. Otherwise, these two groups were comparable. Conclusion: The use of 2-mSv CT instead of conventional-dose CT impairs appendiceal visualization in more patients. However, appendiceal nonvisualization on 2-mSv CT rarely leads to undesirable clinical or diagnostic outcomes.

A Study on Bang-Yak-Hap-Py$\breve{u}$n (${\ll}$방약합편(方藥合編)${\gg}$에 대한 연구)

  • Kim, Hyung-Tae;Yoon, Chang-Yeul
    • Journal of Korean Medical classics
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    • v.5
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    • pp.151-199
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    • 1992
  • A study on Bang-Yak-Hap-Py$\breve{u}$n, one of the most widely-known Korean medicine books, has been conducted and the findings are as follows:the political and social background at the end of Yi-dynasty amidst the inflow of western civilization and the aggression of foreign forces can be seen as a historical period of trial, when civilization and independence had to be preserved at the same time, during the period, the social trend was to pursue a rapid practical solution rather than a profound theory. Responding to this trend, simple and easy medical science became to prevailand the representative medicine book of this kind was Bang-Yak-Hap-Py$\breve{u}$n. 1. Bang-Yak-Hap-Py$\breve{u}$n was written comprising the characteristics of simple and easy medical science with a view to popularizing-collection of logics, easy readability, medical science in time, etc. 2. Bang Yak-Hap-Py$\breve{u}$n, rich and grand in content, came out of Dong-$\breve{U}$i-Bo-Gam at the right moment as a pragmatic guide book of Korea medical practice symbolizing Korean spirit. 3. Do-yun Whang whose pen name was Hye-Am was born in Changwon, Kyungnam-do as the 18th descendant of Changwon Whang family. He engaged in medical practice in Seoul and wrote and edited Boo-Bang-Py$\breve{u}$n-Ram. $\breve{U}$i-Jong-Son-Ik, $\breve{U}$i-J$\breve{u}$ng-Son-Ik-Bu-Yeo, $\breve{U}$i-Bang-Whan-Tu, ect. and made his son, Pil-Su follow him and let him edit Bang-Yak-Hap-Py$\breve{u}$n, which put $\breve{U}$i-Bang-Whal-Tu and Son-Ik-Bon-Cho together. 4. The construct of Bang-Yak-Hap-Py$\breve{u}$n can be subdivied into three parts: herbs of 34 classes and 514 kinds were arranged on the upper part and $\breve{U}$i-Bang-Whal-Tu was arranged on the middle end lower part. Such arrangement can be very effective in clinics. 5. Bang-Yak-Hap-Py$\breve{u}$n as a curative book of Korean medical science has been a necessary another ego for many Korean medical practioners. It also played a great role of enhancing Korean oriental medical science to be widely used by Koreans. On the other hand, it produced a side effect of emergence of employed medical practioner who lacked in scholastic aptitude. 6. Tens or newly edited Bang-Yak-Hap-Py$\breve{u}$n have been issued. Among them, Jung-Jeong, Bang-Yak-Hap-py$\breve{u}$n, J$\breve{u}$ng-Mak-Bang-Yak-Hap-Py$\breve{u}$n. By$\breve{u}$n-J$\breve{u}$ng-Bang-Yak-Hap-Py$\breve{u}$n, and By$\breve{u}$n-J$\breve{u}$ng-Bang-Yak-Jung-Jeon have been widely known. Lately, Bang-Yak-Hap-Py$\breve{u}$n which includes more symptoms and remedies or is translated into Korean came out in several kinds. 7. The number of korea classical medicinal books quoted in Bang-Yak-Hap-Py$\breve{u}$n is 68, among which Dong-$\breve{U}$i-Bo-Gam Occupies the top in the list enlisting 69 medicinal treatment. This Shows that Dong-$\breve{U}$i-Bo-Gam gave birth to Bang-Yak-Hap-Py$\breve{u}$n.

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