Informing real-world practice with real-world evidence: the value of PRECIS-2

BMC Med. 2018 May 21;16(1):76. doi: 10.1186/s12916-018-1071-1.


Real-world evidence is needed to inform real-world practice. Pragmatic controlled trials are intended to provide such evidence by assessing the effectiveness of medicines and other interventions in real-world settings, as opposed to explanatory trials that assess efficacy in highly controlled settings. Dal-Ré and colleagues (BMC Med 16:49, 2018) recently performed a literature review of studies published between 2014 and 2017 to assess the degree to which studies that self-identified as pragmatic were truly so. The authors found that over one-third of randomized controlled trials of drugs and biologics that were self-labeled as pragmatic used placebo controls (as opposed to usual care), tested medicines before licensing, or were conducted in a single site. Further, they proposed that, in order to improve the reliability of the 'pragmatic' label, investigators should assess their trials using the PRECIS-2 tool upon submission to funders, ethics boards, or journals. We appreciate the value of PRECIS-2 as an indicator to assess the pragmatic versus explanatory features in a trial, and we herein highlight the potential challenges and opportunities that may arise with its systematic and widespread use.

Keywords: Effectiveness; Explanatory trials; PRECIS-2; Pragmatic trials; Real-world evidence; Usual clinical practice.

Publication types

  • Letter
  • Comment

MeSH terms

  • Reproducibility of Results
  • Research Design*