Applying the PRECIS-2 tool for self-declared 'pragmatic' acupuncture trials: protocol for a systematic review.

Abstract

The pragmatic design has received much attention in the field of acupuncture clinical trials because of insufficient information about the specific effects of acupuncture. However, pragmatism in pragmatic acupuncture trials has not been comprehensively investigated. The PRECIS-2 tool was developed and has been gradually used to design pragmatic trials; therefore, we will apply the PRECIS-2 tool to investigate the pragmatism of pragmatic acupuncture trials in this study. In this systematic review, self-declared 'pragmatic' randomised clinical trials (RCTs) or protocols of self-declared 'pragmatic' RCTs investigating acupuncture will be searched and included to be reviewed. MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov for registered trials will be electronically searched from inception to March 2022. Protocols of published RCTs or secondary analysis of RCTs will be excluded. Additionally, no language restriction will be applied. Two authors will independently extract descriptive information and assess the pragmatism of pragmatic acupuncture trials using nine domains of the PRECIS-2 tool and one additional domain-control. Descriptive statistics will be reported for each domain and the overall score, and a one-sample t-test will be used to statistically analyse whether the score is greater than 3 (equally pragmatic and explanatory). The wheel diagrams of the nine domains of the PRECIS-2 tool will be used to demonstrate the pragmatism of the included studies. Ethical approval is not warranted as this study will obtain data from previously reported articles. The results will be disseminated through peer-reviewed journals and conferences. CRD42021236975.