(1) UC-1 looks very much like reinventing the wheel. The standards described here appear to want researchers to draw on existing evidence to describe their usual care intervention but appear to have completely missed the 2014 TIDieR guidelines which set out how to do this in detail (https://doi.org/10.1136/bmj.g1687). The PCORI guideline would be much easier to follow, and would make the resulting studies of more international use if (i) if it told researchers to describe usual care using TIDieR, and added whatever extra items if any might be of specific US relevance and (ii) told them to describe their study interventions using the same tools.

(2) Sometimes in a pragmatic trial there is no one ‘usual care’ to use as a comparator - care differs across different providers. In that case there is a decision to be made whether to fix a ‘usual care’ for a study (a less pragmatic approach) or to describe the basket of usual care across study sites and try to explore in analysis whether these differences are important (a more pragmatic approach). The guidance here doesn’t seem to allow for the second situation, insisting on a detailed description of usual care at the application stage. This might not be possible, especially if all recruiting sites are not yet known. In this case I’d expect an application to set out a range of acceptable activities in usual care - but not define a particular approach to usual care in great detail. The study report would need to describe in more detail what was done in the usual care arms, probably using the TIDieR framework.
Andrew Cook
University of Southampton, UK
Prefer to self-describe
Clinical Trialist, Research Funder, Clinician
Representing my own views