PRECIS-2 helps researchers design more applicable RCTs while CONSORT Extension for Pragmatic Trials helps knowledge users decide whether to apply them

Abstract

First paragraph: We appreciate the efforts of the editors of the Journal of Clinical Epidemiology to provide a forum for discussion of pragmatismi in randomized trials (RCTs), with many items in recent years, including three in this issue by Dekkers et al ii, Zuidegeest et al. iii and Riddle iv. We are encouraged that these three authors agree on the importance of pragmatism and the relevance of PRECIS-2 to RCT designv, our tool to promote better matching of the choices made during design with the intended use of that trial’s results. We thank them for their insightful comments relating to the varied meanings of generalizability, and the relationship between pragmatic and explanatory characteristics and internal validity and applicability (which we use as a synonym for generalizability) of trial results, to which we respond below.