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

• Main Authors: Gila Neta, Karin E. Johnson
• Format: Article
• Language: English
• Published: BMC 2018-05-01
• Series: BMC Medicine
• Subjects: Pragmatic trials; Explanatory trials; Real-world evidence; Effectiveness; Usual clinical practice; PRECIS-2
• Online Access: http://link.springer.com/article/10.1186/s12916-018-1071-1

Abstract 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.