• 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 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.

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

• 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.

• Journal of Acupuncture Research
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• v.41 no.2
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• pp.107-114
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• 2024

Background: Low back pain (LBP) is a common musculoskeletal disorder worldwide, with a lifetime prevalence of up to 80%. Among nonsurgical treatments for chronic LBP, Korean medicine treatments are highly preferred, and pharmacopuncture therapy combining acupuncture and herbal medicine is widely used. However, no evidence-based study has focused on the use of various types of pharmacopuncture. Methods: The pragmatic randomized controlled clinical trial will include 44 participants; recruitment will start in July 2023. All participants will receive integrated Korean medicine treatment including acupuncture, cupping, and infrared therapy, and the intervention group will also receive pharmacopuncture. After 16 treatment sessions, twice a week for 8 weeks, follow-up assessments will be performed at week 9. As a pragmatic randomized controlled clinical protocol, the type, dose, and acupoints of acupuncture and pharmacopuncture are not determined in advance but are selected and recorded according to the clinical judgment of the Korean medicine doctor. Results: The primary outcome will be measured using a visual analog scale score, and the secondary outcomes include the Oswestry disability index, patient global impression of change, no worse than mild pain, and range of motion. Safety will be assessed by examining participants' self-reported adverse events and vital signs and conducting blood tests before and after the test. Conclusion: This study aims to provide clinical evidence of the effectiveness and safety of pharmacopuncture for chronic LBP.

• 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.

• The Journal of the Korea Contents Association
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• v.12 no.5
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• pp.280-292
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• 2012

Cognitive-pragmatic language ability decreases during the normal aging process. Evaluating the ability might be useful in testing predicting cognitive level and diseases such as dementia. The aim of this study is to analyze various assessment protocols for normal aging, and evaluate the content validity of the currently developing cognitive-pragmatic language test domains and items. Content Validity Index(CVI) was calculated based on ratings judged by 17 experts including speech-language pathologists and clinical psychologists. As a result, it was found that CVIs of all 7 domains including attention, memory, organization, reasoning, problem solving, executive function, pragmatic language were above .75. It was concluded that the test items contained the appropriate content validity to assess cognitive-pragmatic language for normal aging.

• CELLMED
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• v.6 no.4
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• pp.27.1-27.4
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• 2016

Anxiety is a common clinical presentation. Primary anxiety poses a significant problem in its management. Many among the current treatment options of anxiety are habit forming causing significant withdrawal symptoms. There are dose dependent responses often associated with drug adversities. Day time sedation is an undesired effect of many drugs used for anxiety management limiting its usage. Ayurveda recommends a bio- physical procedure to manage anxiety. Shirodhara, a dripping procedure is utilized as a front line therapy for anxiety in Ayurveda. Seeing the limitations of conventional biomedical management of anxiety requiring an improvement upon the existing protocols of managements, and also seeing the use of shirodhara for anxiety management in ayurvedic clinics, a pragmatic study to evaluate the effect of shirodhara in generalized anxiety disorder was done. This was a pragmatic study consisting of shirodhara with ksheer bala oil as an intervention upon generalized anxiety disorder patients. The study was conducted upon 13 patients and observations were done for six weeks. The responses observed through the changes in Hamilton Anxiety Scale were evaluated using paired t test to observe the pre-post significance.

• 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 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.