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

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 nine PRECIS-2 domains: first independently using an online version of PRECIS-2 and second following a discussion.

RESULTS

Seven teams took part in the study. Before the discussion, within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved after the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, although 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-randomized trials, greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and another at the cluster level.