PRECIS: The Pragmatic Explanatory Continuum Indicator Summary (April 2009)

Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis SR, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. CMAJ. 2009;180(10):E47-57. doi: 10.1503/cmaj.090523. PMID: 19372436

PRECIS provides a framework for describing and evaluating key features that researchers should consider when designing trials to meet the need of post-regulatory decision makers (patients, clinicians, payers, and policy makers). Although in general, more pragmatic clinical trials will include many of the “pragmatic” features described in the PRECIS instrument, the ultimate decision regarding specific features of trial design will depend on the research question being addressed and the evidence needed by the end user.  A novel aspect of this PRECIS framework is therefore the blurry distinction between a pragmatic and explanatory randomized trial, hence the authors use a “continuum” to illustrate the fact the two are not always mutually exclusive.