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PCORI has completed eight cycles of research funding since our inception. We very much appreciate the time and resources that our applicants commit when proposing projects to us and that our reviewers devote to evaluating applications. So with each cycle, we work to improve and refine our processes, guided by applicant and reviewer input about what works and what we can do better.
In response to such feedback, we have made a variety of changes in the PCORI Funding Announcements (PFAs) released today. These Cycle 3 2015, announcements invite applications for targeted, or topic-specific, projects; pragmatic clinical studies (PCS); and projects under PCORI’s five national priorities for research (our “broad” PFAs).
Administrative Updates
New Milestones/Deliverables Template. Applicants have told us it’s redundant to include project milestones in both PCORI Online and the Research Plan. So we’ve improved our process and, as of this cycle, applicants will enter milestones in a single place—the Milestones/Deliverables Template—and upload that template as a PDF into PCORI Online.
In this new template, applicants must describe the projected outcomes of the proposed study and clearly articulate its goals. Milestones entered int o the template should be specific deliverables associated with project objectives, and applicants must note targeted dates of completion. The template provides an example of how applicants can chart their milestone/deliverable schedule. However, other formats, including Gantt charts, also are acceptable. When a project is funded, we include these milestones and deliverables in the research contract, then monitor the awardee’s performance against them.
Detailed Peer Review Budget. We are in the process of implementing our new Process for Peer Review and Public Release of the Results for all funded studies. We’ve received questions from applicants about budgeting for this process. We now require applicants to submit a Peer Review Budget as well as the Research Project Budget. Applicants will complete a detailed budget for the peer review process and enter it in the Peer Review Budget tab of the Detailed Budget Template. Our Application Guidelines explain how applicants should enter these costs into the Budget Template.
For determining compliance with the maximum project budget stated in the PFA, the Total Budget includes the Peer Review Budget and the Research Project Budget. Related instructions are provided in the Application Guidelines for the targeted, PCS, and broad, including methods, PFAs. These include:
- Limits on the level of effort for the Principal Investigator and administrative staff for the completion of the Peer Review Process
- Salary cap applied to the Peer Review Budget
- Budget justification for the Peer Review Budget
- Inclusion of the Peer Review Budget in the Budget Summary
Merit Review Changes
Also in response to reviewer and applicant feedback, we have clarified and streamlined our review criteria for the new funding cycle. The revisions improve our guidance for applicants and reviewers by clarifying the type of information we seek for each criterion.
We hope the revised criteria provide a clearer understanding of how applications will be evaluated and help applicants submit strong proposals. These revisions will also better guide our reviewers as they evaluate applications and enhance our ability to provide actionable feedback to applicants.
The table below highlights the changes. Our scientist reviewers will continue to evaluate all criteria, and our patient and other stakeholder reviewers will continue to focus on Criteria 2, 4, and 5.
We encourage applicants to perform a careful review of our PFAs to guide application development and better understand how applications will be evaluated.
| Old Criteria | New Criteria | Rationale for Revision | |
|---|---|---|---|
| Criterion 1 | Impact of the condition on the health of individuals and populations | Potential for the study to fill critical gaps and generate actionable evidence CER Methods PFA only: Study identifies critical methodological gap(s) in PCOR/CER | Places primary emphasis on potential to fill an evidence gap CER Methods PFA only: Provides clearer guidance on interest in filling methodological gaps |
| Criterion 2 | Potential for the study to improve health care and outcomes | Potential for the study findings to be adopted into clinical practice and improve delivery of care CER Methods PFA only: Potential for the study to improve PCOR/CER methods | Focuses on reproducibility and potential to change practice and delivery Provides better guidance to prompt applicants and reviewers to consider barriers to adoption by end users of study findings CER Methods PFA only: Includes guidance regarding the program’s interest in novelty and overall potential to improve current practice and standards |
| Criterion 3 | Technical merit | Scientific merit (research design, analysis, and outcomes) | Streamlines and clarifies guidance |
| Criterion 4 | Patient-centeredness | Patient-centeredness (bullets revised) | Provides more explicit guidance to applicants and reviewers on meaningful patient-centeredness Better differentiates this criterion from criterion 5 CER Methods PFA only: Better guides evaluation of patient- centeredness of proposed methods |
| Criterion 5 | Patient and stakeholder engagement | Patient and stakeholder engagement (bullets revised) | Better differentiate from patient- centeredness CER Methods PFA only: Better explains expectations regarding engagement |
View and download a PDF version of the table here.
Patient and Other Stakeholder Engagement
As of this cycle, the engagement approaches outlined in our broad PFAs will differ slightly from those in the PCS and targeted PFAs. PCORI believes that meaningful engagement by patients and other stakeholders is a critical component of patient-centered outcomes research and comparative effectiveness research. The primary difference between the engagement requirements in the broad PFAs and those in the PCS and targeted PFAs is one of timing and scale.
The topics around which the PCS and targeted PFAs are drafted were identified through a lengthy, multi-stakeholder process, underscoring the importance and relevance of these topics to the patient and other stakeholder communities. Applicants to these funding announcements must demonstrate how, upon receiving a contract for funding, they will engage their relevant patient and other stakeholder partners as described here.
Conversely, the broad PFAs are not oriented around a previously prioritized and identified topic. Therefore, applicants must demonstrate active patient and other stakeholder partnership and support for the topic idea, research gap, and decisional dilemma at the time of proposal submission.
The other key distinction between these funding announcements is the scope and scale of the awards, with the PCS and targeted PFAs being significantly larger in project size and dollar amount. The engagement costs are thus much greater for these than for the broad PFAs. We heard from applicants that the cost of engaging patients and stakeholders on a national or regional scale prior to award was prohibitive; the revised engagement requirements allow for the cost of engagement to be covered fully by the contract. Additionally, it prevents attempts to form partnerships for applications that may not be funded and thus result in financially unsustainable engagement activities.
To support our broad PFA applicant community, we have PCORI’s Pipeline to Proposal Awards program, a competitive funding opportunity that provides three tiers of engagement funding for patients, researchers, and other stakeholders interested in potentially submitting a PCORI research proposal.
Additionally this cycle, the PCORI Engagement Rubric has been revised and updated for better readability and use. We have added new examples to reflect engagement from our more recent cycles, including our large pragmatic studies. We have also removed the stand-alone “PCOR Principles” section and embedded the concepts of the six PCOR principles throughout the three chronological sections of the rubric: Planning, Conduct, and Dissemination.
These refinements reflect PCORI’s ongoing evolution as a research funder whose work is guided by feedback from stakeholders from across the healthcare community. We hope you find them helpful and responsive to your input.
