Patient-Centered Outcomes Research Institute
Management Strategies for Treatment-Resistant Depression - Cycle 3 2015
- Is this a one-time solicitation?
- 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.
- Can an organization submit more than one LOI for this PFA?
- Is PCORI interested in only the specific subgroups listed within this PFA?
- Is it a requirement that the treatment arms compare augmentation to switching?
- How is “adequate course of antidepressant treatment” defined?
- For a study comparing health system–level interventions where the primary analyses are patient-centered outcomes, can funding be used to conduct secondary analyses of economic impacts?
- What do you mean by “powering the study for subgroups of interest”?
- Will an interaction test be less powerful than subgroup-specific tests? If you can demonstrate that an intervention can work in a variety of subgroups, is it required to demonstrate how those effects differ between subgroups?
- Would financial incentives to patients to increase medication adherence be an appropriate comparison intervention?
- If I have a design that compares the effectiveness of two alternatives, would it be acceptable to include usual care as a third arm?
- Can one comparative-treatment option be a new option for patients? For example, can it be enhanced care based on the literature but not currently in routine practice?
- What if there is no recent systematic review on the research gap that my research study will address?
- As a secondary aim, can I propose to measure treatment costs but not compare them? Or should I refrain from this area entirely, except for patient costs?
- Can my proposed study address the priority research question, but only for a specific population?
- How was the priority research question selected?