Randomized Controlled Pragmatic Trial: Concept, Design, Practice_Chinese Journal of Evidence-Based Medicine

Authors：

 WU Taixiang ¹ , SHANG Hongcai ² , BIAN Zhaoxiang ³

1. Chinese Clinical Trial Register, Chinese Evidence-Based Medicine Center, Chinese Cochrane Centre, INCLEN CERTC, West China Hospital,Sichuan University, Chengdu 610041, China;2. Evidence-based Medicine Center of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;3. School of Chinese Medicine, Hong Kong Baptist University;

Corresponding author：

WU Taixiang, Email: txwutx@hotmail.com

Keywords：

Randomized controlled trial; Pragmatic trial; Chinese medicine; Clinical pathway

DOI：

10.7507/1672-2531.20090232

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The two factors that affect enrollment of participants and the process of intervention in randomizedcontrolled pragmatic trials are similar to the situation of clinical practice, thus its effects are similar to the situation ofclinical practice. Therefore, when one estimates an intervention’s effect on a patient, it will be more similar to a real clinicalsituation than results taken from an explanatory trial. Due to the introduction of interventions and process variables usedin a pragmatic trial that conform to traditional Chinese medicine and acupuncture practices, more and more interest isgrowing among researchers in the traditional Chinese medicine field. This article introduces the principles and conceptsof the pragmatic trial, and the key points of design via some samples.

Citation： WU Taixiang,SHANG Hongcai,BIAN Zhaoxiang. Randomized Controlled Pragmatic Trial: Concept, Design, Practice. Chinese Journal of Evidence-Based Medicine, 2009, 09(12): 1277-1280. doi: 10.7507/1672-2531.20090232 Copy

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2.	Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis, 1967, 20(8): 637-648.
3.	Shaun T, Merrick Z. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials, 2009, 10: 37.

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Chinese Journal of Evidence-Based Medicine

Randomized Controlled Pragmatic Trial: Concept, Design, Practice

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