The application of PRECIS-2 ratings in randomized controlled trials of Chinese herbal medicine
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Liming Lu1, Li Zhou1, Jing Dong1, Yu Xiang1 and Zehuai Wen1,2
1The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
2National Center for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, China
Zehuai Wen, email: [email protected]
Keywords: pragmatic-explanatory continuum indicator summary (PRECIS); Chinese herbal medicine; comparative effectiveness research (CER); randomized controlled trials (RCTs)
Received: April 28, 2017 Accepted: September 20, 2017 Published: October 31, 2017
This study tests the feasibility of applying the pragmatic-explanatory continuum indicator summary (version “PRECIS-2”) tool to randomized controlled trials of Chinese herbal medicine. A search was conducted to identify potentially eligible randomized controlled trials. Using the PRECIS-2 tool, assessment of trials was performed independently by 2 evaluators using a scale of 1–5 for each criterion (1 = maximal efficacy, 5 = maximal effectiveness). A total of 7,166 reports were retrieved from databases and 159 were included in the full text. Though PRECIS-2 describes quantitative scoring in detail, evaluators were uncertain about several specific operationalizations and found high evaluator variation in the first independent ratings. After discussion and reaching consensus, inter-evaluator reliability improved. For PRECIS-2 ratings over time, there was no evidence that the design and performance of RCTs of CHM paid more attention to “efficacy” criteria after the implementation of PRECIS (all P > 0.05). More research is needed to establish the easiest and most useful tool to distinguish between effectiveness and efficacy results.
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