**Note that the comments below represent my opinion and do not reflect the views of my organization**

Please provide your overall impressions of the proposed draft standards.

These standards do not acknowledge the cost in time and effort of documenting the extent to which usual care is implemented.


If you were proposing a study that uses a usual care comparator, how confident are you that you would be able to meet the requirements of the standards?

I would NOT be able to meet these standards for studies situated in safety-net health systems. It would require years of preliminary work to define, describe, and investigate the implementation of usual care.

Are you more or less likely to propose a pragmatic study that uses a usual care comparator for a PCORI funding opportunity if the standards are applied?

I will not be able to meet these standards and am therefore very unlikely to submit studies with usual care as a comparator.

Please identify any requirements or best practices that should not be included in the draft standards. Should any of the components currently listed as a best practice be considered a requirement?

These requirements are already very stringent and I would not add more.
Urmimala Sarkar
University of California, San Francisco
Researcher, health/medical
Representing my own views