Patient-Centered Outcomes Research InstituteClinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain
- What should I do to complete an LOI, and where can I find it?
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- What do you mean by “powering the study for subgroups of interest”?
- Although Letters of Support are not required at the LOI stage, do applicants need to confirm all study sites, especially if one is choosing between a few but needs to be more time regarding visibility and buy-in?
- Medical side effects of treatment are listed as a potential key outcome. Does this mean side effects of the comparators being evaluated or does it mean side effects of opioid therapy?
- What types of observation studies PCORI would be interested in for this PFA?
- Would you consider a comparative study utilizing cannabis as a study arm?
- Must both strategies compared in the study be opioid dose reduction strategies or can one be an opioid risk reduction strategy?
- Is there a minimum amount on the awards that will be issued? Does PCORI support focused projects that request a lesser amount of funding?
- Must study interventions be currently billable/insurance-reimbursable services?
- Can PCORI funding be used to hire a therapist/yoga instructor for the project to deliver the study interventions to patients?
- How was the priority research question selected?