Discussion
The current study builds upon and extends prior investigations that have straddled implementation science and pragmatic clinical trial approaches [The investigation found fair-to-good interrater reliability on the PRECIS-2 and PRECIS-2-PS as assessed by the ICC and Kappa statistics [Commentary spanning pragmatic and implementation science clinical trial approaches suggests that policy integration could accelerate the research-to-practice translation; the recent NIH combined pragmatic and implementation trial announcement emphasized the importance of clinical trial policy relevance [A common pragmatic trial investigative approach has been to work inductively from individual trials to identify potentially integrative methods [Future research could refine the learning health policy systems construct as it relates to pragmatic and implementation randomized clinical trials. Additional investigation could productively focus on the development of continuum indicators/checklists that assess the extent to which clinical trials successfully catalyze health care system practice changes that are temporally linked to pre-specified policy targets. Elements for continuum/checklist ratings might include incorporation of policy levers up-front in clinical trial design, ratings of policy makers’ initial buy-in and sustained commitment to incorporating trial results, and whether the trial included an explicit mechanism for the health care system integration of findings, such as an end-of-study policy summit. Of note, such checklists could be derived from previously identified policy-relevant implementation domains [The investigation also contributes to an evolving literature on PRECIS coder training. Some [The investigation has additional limitations. Raters were drawn from a single study team, and only two trials were rated. This approach may have contributed to decreased variability in ratings across PRECIS-2 and PRECIS-PS domains and pragmatic trials; raters did, however, have varying degrees of familiarity with the two trials. Also, the study team acknowledges that the PRECIS coding occurred at the conclusion of a muti-year investigation; prospective ratings may prove beneficial in future investigations. The training required iterative modifications. An alternative approach would have been to develop a lengthier, more rigorous training up-front. However, as with previous PRECIS training efforts, the study team’s overarching goal was to develop a lower-intensity, more generalizable training procedure that could require context-specific iterative modifications [Beyond these considerations, this investigation also contributes to an evolving literature on the ability of the RAPICE approach to systematically augment quantitative data collected as part of larger-scale health care system trials [