The Patient-Centered Outcomes Research Institute (PCORI) is a nonprofit research funder established by the Patient Protection and Affordable Care Act of 2010 to fund comparative clinical effectiveness research and, more broadly, patient-centered outcomes research (PCOR). For applicants coming from NIH or NSF grant-writing, the single biggest adjustment is that PCORI does not treat patient and stakeholder involvement as a nice-to-have supporting detail — it is a named, separately scored merit review criterion, on par with technical merit. A proposal with excellent methods but a thin or token engagement plan will not score well in PCORI review, in a way that has no direct equivalent in an NIH study section or an NSF panel.
This guide covers what PCORI’s merit review actually evaluates, what “patient-centeredness” means as a review criterion in practice, and how to build a credible patient and stakeholder engagement plan into a proposal. For the mechanics of proposal writing itself — specific aims, budget narrative, biosketches — see CASRAI’s guides on the NIH Specific Aims page and how to apply for an NSF grant; the structural skills transfer, even though the criteria a PCORI reviewer applies to that structure do not.
What PCORI funds, and why its review model is different
PCORI funds comparative clinical effectiveness research (CER) and patient-centered outcomes research (PCOR): studies that directly compare two or more existing approaches to a health problem, on outcomes that patients themselves say matter, and that are designed with patient and stakeholder input rather than designed and then presented to patients afterward. That mandate is written into how PCORI structures merit review. Where NIH study sections and NSF panels are built around scientific and technical peer review by investigators in the field, PCORI review panels also seat patients, caregivers, clinicians, and other health system stakeholders as reviewers with full, equally weighted votes — not as an advisory add-on to a separate scientific panel (PCORI Review Criteria; see also the peer-reviewed analysis “Unique Review Criteria and Patient and Stakeholder Reviewers,” Value in Health, 2018).
PCORI’s merit review criteria
The exact criterion language and weighting are specified in each individual PCORI Funding Announcement (PFA), so applicants should always work from the current PFA rather than a general summary. Across PCORI’s funding announcements, review has consistently organized around a consistent set of criteria (PCORI Review Criteria; Value in Health, 2018):
- Impact of the condition on the health of individuals and populations — whether the health problem addressed carries a significant burden, whether measured by prevalence, mortality, morbidity, and loss of productivity across a broad population, or by severe impact on a smaller population affected by a rare condition.
- Technical merit — whether the research design, methods, and analytic plan are sound enough to answer the question the proposal poses, evaluated the way a methods-focused reviewer would evaluate any comparative effectiveness study.
- Patient-centeredness — whether the research question and the outcomes being measured are ones that matter to patients and were shaped by patient input, rather than outcomes chosen solely on clinical or mechanistic grounds.
- Patient and stakeholder engagement — whether patients, caregivers, clinicians, and other relevant stakeholders (health systems, payers, purchasers, industry, policymakers, and training institutions, as relevant to the topic) are meaningfully engaged in planning, conducting, and disseminating the study — not merely informed of it after the fact.
- Likelihood of providing useful information for patient and clinical decision-making — whether the results, once produced, would plausibly change what a patient and clinician could decide together, which is PCORI’s proxy for real-world actionability rather than purely academic significance.
- Appropriateness of the research team and environment — whether the investigator team, including any patient and stakeholder partners, and the institutional environment have the qualifications, experience, and resources to carry out the proposed work.
Two of these — patient-centeredness and patient/stakeholder engagement — are the criteria without a direct NIH or NSF equivalent, and they are the ones applicants most often underweight when adapting a proposal originally drafted for a different funder.
What “patient-centeredness” means as a scored criterion
Patient-centeredness is not a synonym for “the research is about patients” — nearly all clinical and health services research is, in that loose sense, about patients. As a PCORI review criterion, it asks two more specific questions: did patients help determine that this question was worth asking, and are the outcomes being measured ones patients themselves have identified as important, as opposed to outcomes chosen primarily because they are easy to measure or clinically convenient (mortality and biomarker changes, for instance, versus function, symptom burden, or ability to work). A proposal demonstrates patient-centeredness by showing, concretely, where that input came from — a planning phase with patient partners, findings from prior patient-engagement work, or a stated rationale, grounded in the target population’s own priorities, for why the chosen comparators and outcomes matter to them.
Building a credible patient and stakeholder engagement plan
PCORI publishes an Engagement Rubric that organizes engagement activities across three phases of a study, and reviewers use broadly the same framework in evaluating an application’s engagement plan (“The PCORI Engagement Rubric,” Annals of Family Medicine, 2017):
- Planning the study — engaging patients and stakeholders in identifying the research question, selecting comparators and outcomes, and shaping the study design before the application is finalized, not after funding is awarded.
- Conducting the study — involving patient and stakeholder partners in refining recruitment and retention strategies, interpreting interim findings, and participating in decisions that arise during the study, typically through a standing advisory role rather than a one-time consultation.
- Disseminating the results — involving patients and stakeholders in deciding how findings are communicated back to the populations affected, including plain-language formats, not only in academic publication.
A proposal’s engagement section should be specific about who the patient and stakeholder partners are (or how they will be identified and recruited if not yet named), what role they will actually play at each phase above, how frequently they will be consulted, and how their input will be compensated and acted on. Reviewers can generally distinguish an engagement plan that describes a genuine, resourced partnership from one that lists an advisory board in name only with no described mechanism for that board’s input to change the study. Budgeting explicitly for patient partner time, training, and compensation is one of the more concrete, checkable signals of a credible plan, and its absence is a common, avoidable weakness.
Merit review process, in outline
PCORI merit review runs through an external review panel that includes scientific reviewers and patient/stakeholder reviewers, with each reviewer’s score weighted equally regardless of reviewer type. Applications typically go through a preliminary review stage, followed by an in-person (or virtual) panel discussion of a subset of applications, with reviewers scoring against the criteria set out in the specific PFA. Because the exact scoring scale, weighting, and number of review stages vary by funding announcement and PCORI updates its process periodically, applicants should confirm the current mechanics against the Merit Review section of the specific PFA they are applying to and PCORI’s own Merit Review page rather than relying on a fixed description of the process.
How this differs from writing for NIH or NSF
Structurally, a PCORI application still requires the same core components most federal-style proposals require — specific aims or a research question, background and significance, research design and methods, a budget and budget justification, and a research team with appropriate qualifications, all of which the guidance in CASRAI’s NIH Specific Aims page guide and NSF application guide is directly transferable to. What does not transfer is the weighting: an NIH or NSF proposal succeeds primarily on scientific significance, innovation, and investigator/team rigor, evaluated by scientific peers. A PCORI proposal is evaluated by a panel that includes non-scientist patient and stakeholder reviewers with equal voting weight, against criteria that explicitly separate “is this good science” from “is this the science patients need, designed with their input.” Treating the engagement plan as a compliance section to fill in after the scientific design is finalized, rather than as a co-equal design input from the outset, is the most common reason proposals adapted from an NIH or NSF draft underperform in PCORI review.
For related background on how patient involvement functions once a study is funded and running — distinct from the proposal-stage engagement plan covered here — see CASRAI’s guide to patient engagement in clinical trials and the dictionary entry on the patient partner role.
Frequently asked questions
Is PCORI a federal agency like NIH?
No. PCORI is an independent, nonprofit organization authorized and funded through the Patient Protection and Affordable Care Act of 2010, not a federal agency, though it is subject to congressional oversight and its funding flows through the Patient-Centered Outcomes Research Trust Fund. Its application and review processes are its own, separate from NIH’s or NSF’s, even where terminology overlaps.
Can a patient or caregiver be listed as an investigator on a PCORI application, not just an advisor?
PCORI’s model explicitly encourages substantive patient and stakeholder partnership roles beyond an advisory committee, and applications increasingly name patient co-investigators or patient partners with defined roles and effort. The specific roles, titles, and any effort/compensation mechanics allowable depend on the funding mechanism and should be confirmed against the current PFA and your institution’s research administration office, since compensation structures for non-employee patient partners raise institution-specific payroll and consulting-agreement questions that a proposal budget needs to resolve early.
What is comparative effectiveness research (CER)?
Comparative effectiveness research directly compares two or more existing, available interventions, tests, or care strategies against each other on outcomes that matter to patients, rather than comparing a single intervention against placebo or usual care in isolation. It is the methodological core of most PCORI-funded research, distinct from efficacy research aimed at establishing whether a new intervention works at all.
Does a PCORI proposal need IRB approval documentation at submission?
Requirements for human subjects protections documentation are set out in the specific PFA and follow standard human-subjects research practice; as with any funder, full IRB approval is typically required before the study begins rather than at the time of application, but applicants should confirm the current requirement against the PFA rather than assume it matches an NIH or NSF timeline.
Sources and further reading
- PCORI, PCORI Review Criteria
- PCORI, Merit Review
- Selby, J.V. et al., “Unique Review Criteria and Patient and Stakeholder Reviewers: Analysis of PCORI’s Approach to Research Funding,” Value in Health, 2018
- Sheridan, S. et al., “The PCORI Engagement Rubric: Promising Practices for Partnering in Research,” Annals of Family Medicine, 2017
