The application of PRECIS-2 ratings in randomized controlled trials of Chinese herbal medicine

// Liming Lu 1 , Li Zhou 1 , Jing Dong 1 , Yu Xiang 1 and Zehuai Wen 1, 2 1 The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China 2 National Center for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, China Correspondence to: Zehuai Wen, email: wenzh@gzucm.edu.cn 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 ABSTRACT 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.