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논문KCI 등재

뜸 임상시험 가이드라인 개발 연구

Development of the General Guideline for Clinical Trial of Moxibustion

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초록

To improve quality of clinical research for moxibustion, a guideline of clinical research protocol is needed. So we developed guideline by a systematic review of the literature and experts from each field reviewed and consulted it. And we made checklist by arranging keypoint of Moxibustion Randomized Controlled Clinical Trial Guideline(MOXRATE). This guideline aims to be a guide for future researchers in planning moxibustion studies and to allow them to report on ethical issues.

Abstract

To improve quality of clinical research for moxibustion, a guideline of clinical research protocol is needed. So we developed guideline by a systematic review of the literature and experts from each field reviewed and consulted it. And we made checklist by arranging keypoint of Moxibustion Randomized Controlled Clinical Trial Guideline(MOXRATE). This guideline aims to be a guide for future researchers in planning moxibustion studies and to allow them to report on ethical issues.

참고문헌 (13)

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  2. Schulz KF, "CONSORT 2010 statement : updated guidelines for reporting parallel group randomised trials", Int J Surg, 10(1), pp.28~55 (2012)
  3. MacPherson H, "Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA): extending the CONSORT statement", PLoS Med, 7(6) (2010)
  4. Gagnier JJ, "Reporting randomized, controlled trials of herbal interventions : an elaborated CONSORT statement", Ann Intern Med, 144(5), pp.364~367 (2006)
  5. Cheng CW, "Extending the CONSORT Statement to moxibustion", J Integr Med, 11(1), pp.54~63 (2013)
  6. Ma B, "Do the CONSORT and STRICTA Checklists Improve the Reporting Quality of Acupuncture and Moxibustion Randomized Controlled Trials Published in Chinese Journals? A Systematic Review and Analysis of Trends", PLoS One, 11(1) (2016)
  7. 이향숙, "STRICTA(침 임상연구에서 중재 보고를 위한 표준) 개정판 : CONSORT Statement의 확충안", Korean Journal of Acupuncture, 27(3), pp.1~23 (2010), 경락경혈학회
  8. Kim SY, "Quality assessment of randomized controlled trials of moxibustion using STRICTOM and ROB", JAMS (2017)
  9. Lynn MR., "Determination and quantification of content validity", Nurs Res, 35, pp.382~385 (1986)
  10. Zaslawski C, "Ethical considerations for acupuncture and chinese herbal medicine clinical trials : a cross-cultural perspective", Evid-Based Complement Altern Med, 7(3), pp.295~301 (2010)
  11. White AR, "International acupuncture research forum. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding", Complement Ther Med, 9(4), pp.237~245 (2001)
  12. Evaluation guideline of herbal medicine clinical trial: antitussive expectorant medicine, "Korea Food and Drug Administration Herbal Medicine Policy Division", Korea Food and Drug Administration, ~ (2007)
  13. 임정태, "침구임상시험 가이드라인 개발과정에서 IRB의 윤리적ㆍ과학적 지적사항 사례 조사 연구", Journal of Acupuncture Research, 32(2), pp.11~21 (2015), 대한침구의학회

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