Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2

Abstract

Objective  To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion.  Study Design and Setting  We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion.  Results  Seven teams took part in the study. Prior to the discussion within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved following the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, though some domains were more pragmatic than others.  Conclusion  PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully we recommend a discussion between those with detailed understanding of: what usual care is for the intervention, the trial’s design including operational and technical aspects, and the PRECIS-2 domains. For some cluster randomised trials greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and one at the cluster level.