The May 6 deadline is approaching for researchers to submit applications in response to the five broad PCORI Funding Announcements (PFAs) issued under our Spring 2014 funding cycle. We’ll be awarding up to $71 million to expand our portfolio of patient-centered research projects and, as always, look forward to receiving the research community’s best ideas to foster that goal.
In previous award cycles, we’ve been encouraged by the increasing number of high-quality applications we’ve seen, as researchers become more familiar with our unique application and review criteria. As more proposals meet our requirements for patient-centeredness and technical merit, we will be able to make more competitive awards.
We have a strong interest in expanding even further the number of proposals we receive that meet these standards. So to help you make your application exceptional, we’re providing some guidance on aspects of our funding opportunities that we find—based on the feedback we’ve received and our internal evaluation processes—have challenged previous applicants. We hope researchers who completed Letters of Intent (and, in the case of competitive LOIs, were invited to submit a full application) will find this information helpful in refining their proposals. These suggestions are aimed particularly at those submitting proposals under our five broad priority areas, rather than under our targeted funding announcements or new Pragmatic Clinical Studies funding initiative, which we’ll discuss in a later blog post.
Spring 2014 Opportunities Under PCORI’s National Priorities for Research
Funds Available Up To
What are the key traits of a strong proposal that have commonly been absent in previous funding cycles?
There are three elements of a strong proposal that warrant close attention from applicants.
- Applications must answer a major question related to decisions about clinical choices, healthcare delivery, or another relevant issue in the area of the announcement. Clearly illustrate why the proposed research question is worth investigating. In particular, pay close attention to PCORI Methodology Standard RQ1, which states: “Gap analysis and systematic reviews should be used to support the need for a proposed study.”
- Proposals must include patient engagement in their research plan (see below). If patients, those who care for them, and other healthcare stakeholders are involved throughout the process, the findings will be more relevant to real-world needs and more likely to be adopted into practice.
- Proposals should show an understanding of PCORI’s Methodology Standards. The Applicant Training page provides important information on how the standards can be incorporated into proposals.
Which criteria have proven most challenging for applicants?
The criteria around patient engagement and patient centeredness have often been stumbling blocks for applicants. Researchers should carefully differentiate these two distinct concepts. Patient engagement refers to inclusion of patients in the research process, from topic selection through study design and conduct to dissemination of findings. Patient centeredness means addressing questions that patients and their families care about in clinical settings. One of the hallmarks of a strong application is that it includes patient and other stakeholder input, and it demonstrates that those contributors consider the selected research questions and the outcomes important to them.
Applicants must work hard to demonstrate strong patient centeredness and patient engagement, as well as superior technical merit in their submissions.
Applicants responding to our Methods Announcement, particularly those submitting analytic methods proposals, should note that an engagement plan is not required. However, those applicants should provide a clear, defensible rationale for not conducting engagement activities. Even without a full-blown engagement plan, proposals must still be patient-centered, showing clear relevance to patients or other healthcare stakeholders.
Are there specific topic areas researchers should address in their applications?
Although some of our other funding opportunities outline special areas of interest, the announcements listed above remain a broad call for proposals, meaning that we are looking for your best ideas. So please submit your strongest concepts for research related to one of our priority areas. You can learn more about our funding cycles—and when there will be calls for broad and topic-specific responses—in a recent blog from our Contracts team.
In the Addressing Disparities program, we are currently focused on point-of-care, rather than organizational- or policy-level, interventions because we have better understanding of how to effectively incorporate patient engagement. With that focus, we can address questions faced by patients and other clinical-care decision makers to provide information that can improve practice and outcomes.
The Improving Methods for Conducting Patient-Centered Outcomes Research program has a special interest in patient-centered outcomes (PCOs) and patient-reported outcomes (PROs). So, we have dedicated a separate funding stream to projects focused on the Patient Reported Outcome Measurement Information System (PROMIS). PCO and PRO methodological research will be accepted under both the PROMIS category and in the regular Improving Methods funding stream. The Improving Methods Funding Announcement goes into specific detail about what types of questions related to PCO and PRO applicants may address.
Also note that Improving Methods funding will not be awarded to projects to develop or validate disease- or condition-specific instruments.
The Improving Healthcare Systems program has recognized that systems change may require a larger investment of research time and funding than some other challenges in this area. Therefore, IHS has instituted a two-level funding stream. The first level funds projects of up to $1.5 million in direct costs over 3 years. The second funding stream, available to researchers who can demonstrate the need for a larger and longer project, will fund projects of up to $5 million in direct costs over 5 years. For this second-level funding, you must make a convincing case that the larger, longer funding is required to accomplish your research aims.
Are there specific study designs that researchers should employ?
Researchers should select the study design that best aligns with their proposed topics and will answer the research question in the most efficient and effective way. For some types of research, a randomized controlled trial will work well. For others, novel or innovative designs may be required. PCORI has funded proposals that employ cluster randomization, quasi-experimental designs, convenience sampling, prospective cohort studies, pre- and post-designs, and other strategies.
What are the common misperceptions applicants have about the funding announcements?
Some applicants have failed to fully comprehend PCORI’s requirement for comparative clinical effectiveness research (CER). With the exception of the Improving Methods announcement, all proposals must include a comparison group. Projects may compare two or more clinical interventions (which can include carefully described usual care), finding the best approach among alternatives and answering questions that patients and clinicians confront.
For the Addressing Disparities awards, some applicants haven’t realized the importance of focusing on vulnerable populations, including some of the following:
- Racial and ethnic minorities
- Individuals with limited English proficiency
- Populations with low socioeconomic status
- Rural populations
- People with disabilities
- Lesbian, gay, bisexual, and transgender individuals.
What role do PCORI’s Methodology Standards play in the review and scoring of submissions?
In previous cycles, we have seen some confusion over the role of PCORI’s Methodology Standards in the scoring of research applications. We recognize that a variety of study designs and analytic methods can produce valid new knowledge. Regardless of the particular methods employed, all proposals must use rigorous methodology guided by the PCORI standards, when appropriate. We strongly encourage researchers to take advantage of the Applicant Training page, which provides detailed information.
What tools have applicants found most helpful throughout the application process?
The Applicant Training page is an excellent resource for researchers developing a proposal for PCORI funding. It includes tutorials geared toward specific categories of funding announcements and answers many questions applicants face during the submission process. The funding announcement pages for the specific awards are also good resources for those preparing submissions. If you click on the name of each announcement at the Funding Center, you will find links to Applicant Resources, including Frequently Asked Questions, an Application Checklist, and Application Guidelines that support the development of responsive proposals.
How can an applicant find answers to other questions?
PCORI operates a helpdesk to assist applicants with questions they have while developing their submission. Researchers can call 202-627-1884 or complete our inquiry form to schedule a call with program staff. PCORI staff will also respond to technical and process-oriented questions sent to email@example.com.
Clauser is the Program Director of PCORI’s Improving Healthcare Systems program
Fleurence is the Program Director of PCORI’s CER Methods and Infrastructure program
Hasnain-Wynia is the Program Director of PCORI’s Addressing Disparities program
Hickam is the Program Director of PCORI’s Clinical Effectiveness Research program
Slutsky is PCORI’s Chief Engagement and Dissemination Officer and Program Director of the Communication and Dissemination Research program
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