My overall impression is that the proposed standards are reasonable. I think it's important to recognize that sometimes "usual care" is the best possible comparator. For a while this was discouraged by PCORI, and I think that was a mistake. The standards make room for enhancements of usual care, to improve its implementation, or to reduce variation.

I think it's possible to meet the requirements in a pragmatic study, either by measurement in a representative subset of the usual care group or by using non-intrusive measurements that are already being collected as part of routine care. I think it's very important to think through what usual care is and how to measure it (fidelity and variation) as outlined in UC-2.

It's hard to foresee the obstacles for all possible topics and interventions, so I think it's fine to describe the best practices rather than make them requirements. Most researchers will try to meet them to improve their chances of a favorable review. If researchers cannot meet them, they should describe why not. This could be revisited in the future once there's more experience with the new standards.
Karen Margolis
HealthPartners Institute
Researcher, health/medical
Representing my own views