• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• Journal of Acupuncture Research
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• v.22 no.2
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• pp.163-170
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• 2005

Background : Over the last thirty years, majority of researches on clinical effectiveness of acupuncture have been explanatory (or experimental) randomized controlled trial. The benefits of acupuncture in clinical trials are still controversial and most studies concluded that further control studies were required. Standardized combinations of acupuncture points for all the experimental subjects in various past studies have been criticized because such treatments do not reflect current routine clinical treatment. Objective : This paper aims to review pragmatic clinical trials on the effect of acupuncture treatment and to develop the ideal clinical research methodology of acupuncture study. Method : Clinical studies of acupuncture relevant with pragmatic or individualized trials were searched mainly in Pubmed and Science direct databases. All articles were fully reviewed by researchers, and data were evaluated by usage of a standardized form. Results & Suggestion : Pragmatic acupuncture researches were tried for various symptoms (eg. low back pain, hypertension, depression during pregnancy, sleep quality in HIV disease, chronic poststroke leg spasticity, headache, etc). Individualized acupuncture treatments based on oriental disease pattern diagnosis reflexes practical treatments which is more effective than unified and fixed acupuncture treatments without any theoretical basis of oriental medical philosophy. Conclusion : To overcome the controversies and limitations of past explanatory acupuncture trials, more individualized and tailored acupuncture trials with the theoretical basis of oriental medical diagnosis is highly recommended. Also clear definition and categorization of pattern identification should be established for further active clinical researches and applications of acupuncture.

• Korean Circulation Journal
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• v.52 no.6
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• pp.401-413
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• 2022

Pragmatic clinical studies, an emerging clinical research discipline, include a wide range of studies that are largely embedded with routine clinical practice and aim to evaluate the comparative effectiveness and safety of different clinical intervention strategies. Increased availability and quality of electronic medical/health records drives the development of pragmatic clinical studies. In this review, we describe evolution of the conceptual framework of pragmatic clinical studies and share perspectives on the importance of pragmatic clinical studies in evidence-based practice for cardiovascular diseases, as a complement to conventional randomized controlled trials. We also highlight specific needs of pragmatic clinical studies in improving evidence-based practice for cardiovascular disease in Asian countries. The main challenges of pragmatic clinical studies are discussed briefly in this review.

• Journal of Korean Academy of Nursing
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• v.52 no.5
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• pp.477-478
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• 2022

• Korean Journal of Radiology
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• v.25 no.2
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• pp.123-125
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• 2024

• Korean Journal of Acupuncture
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• v.31 no.4
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• pp.158-167
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• 2014

Objectives : The results from randomized controlled trials on traditional medicine have been negative or ambiguous. The appropriateness of the research methodology started to be questioned. However, the research methodology appropriate for studying traditional medicine has not been well-established. This study aims to explore the appropriate research methodologies for clinical studies on acupuncture. Methods : Clinical researches evaluating the efficacy and effectiveness of acupuncture for back pain were systematically searched and evaluated focusing on research methodology. The acupuncture treatment protocol is evaluated by 9 items which is individual treatment based on diagnosis, combining proximal and distal acupoints, exact location of acupoint, De Qi, adequate stimulation, duration of acupuncture, treatment sessions, treatment interval, and establishing relationship between patients and doctors. Results : Systematic review of acupuncture researches on low back pain suggested that observational studies and pragmatic trials rather than explanatory studies could incorporate these elements. Qualitative studies also could help understanding complex characteristics of acupuncture treatment which could not be evaluated by quantitative studies. Conclusions : In designing clinical researches on acupuncture, various study designs, especially observational study and pragmatic study, should be considered according to research objectives and subjects. The efforts to incorporate the core characteristics of acupuncture practiced in everyday clinical setting are also essential.

• 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.

• The Journal of Korean Obstetrics and Gynecology
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• v.23 no.1
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• pp.42-52
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• 2010

Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

• Journal of Society of Preventive Korean Medicine
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• v.23 no.3
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• pp.109-119
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• 2019

Background : Germany is the first country in the world to introduce modern systems of public health insurance, and the country which most widely uses complementary alternative medicine(CAM) in Europe. In early 21^st century, a large evaluation studies were conducted to include acupuncture in health insurance payments, which were eventually decided. Objectives : This study is to investigate and analyze the process of public policy determination on insurance coverage for acupuncture in German health insurance system. Methods : We collected the data and information through the literature search and from the websites of German government departments and health insurance organizations. To obtain contextual information, German experts of health insurance and acupuncture clinical study were interviewed. Results : As use of acupuncture had been growing, German public health insurers wanted to evaluate the validity of acupuncture coverage and sponsored three evaluation projects for clinical effectiveness of acupuncture using randomized clinical trials, systematic reviews, and pragmatic trials from 2001 to 2005. For some pain condition, acupuncture was founded not to be effective than sham acupuncture, but more effective than standard care. The federal joint committee of health insurance decided to cover acupuncture for chronic pain of lumbar spine and chronic pain in at least one knee joint due to gonarthrosis. Conclusions : Considering the controversial subject matter in the process of acupuncture's health insurance coverage in Germany, expanding the benefits of Korean medicine in Korea needs to come up with ways to overcome the difficulties of placebo effect, standardization and lack of literature evidence.

• Translational and Clinical Pharmacology
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• v.26 no.4
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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.