Thank you for the opportunity to comment on the draft "Standard for Usual Care as a Comparator". I found 14 projects listed on the PCORI website by entering the search term "usual care" and filtering for projects looking at Serious Mental Illness (SMI). About the third of the listed projects were not the projects but descriptions of PCORI's efforts to fund SMI CER. Another third did not describe usual care and a final third described usual care. Establishing a standard for operationalizing usual care in PCORI funded studies is needed based on a very non-scientific review of these visible projects. In addition, it would be helpful to know whether or not the usual care comparator is associated with minimum levels of expected performance according to Medicaid or Medicare. This is relevant to UC-1 "The usual care comparator must either have demonstrated evidence of efficacy or be in widespread use, though may or may not have established evidence base of effectiveness." In some states the health plans that administer CMMS benefits are not meeting minimum performance levels when usual care is delivered, i.e., usual care is in widespread use but may not be associated with desired levels of health. Adding language to UC-1 that requests information on this aspect of usual care may be informative to PCORI reviewers.
Rose Veniegas, PhD
California Community Foundation
Patient or caregiver advocacy organization
Representing my own views