What’s New in our Fall 2014 Funding Announcements? More Guidance for Applicants

We’re constantly striving to improve the way we seek research applications for projects that will advance our mission of providing useful information to patients, caregivers, clinicians, and other healthcare stakeholders and have a real impact on practice. The research community itself provides us with regular suggestions for how to do that, including telling us that applicants want more guidance on our areas of research interest and the types of projects we seek to fund.

With our newly released Fall 2014 Cycle of PCORI Funding Announcements (PFAs), applicants will notice some significant changes resulting from such applicant feedback. Some of these improvements reflect the evolution of our application process, which we described in a previous blog post. However, these PFAs, issued under our broad National Priorities for Research, also include more detailed information about our areas of research interest and added guidance for applicants seeking to submit proposals that meet the criteria for the types of projects we do—and don’t—intend to fund.

Assessment of Prevention, Diagnosis, and Treatment Options (APDTO)

When deciding how to address any health problem, patients and those who care for them often need to choose between two or more options. To make the best decision, they must have reliable information about the options’ potential benefits and harms. We fund research comparing the effectiveness and safety of different clinical options to see which ones work best for different people with a particular health condition or concern.

The latest PFA issued under our APDTO priority should help applicants submitting applications for such studies in a few ways. It:

• Clarifies that we are seeking direct comparisons of clinical interventions for prevention, diagnosis, or treatment that are delivered directly to defined patient populations rather than tools to guide decisions
• Adds three categories to the list of categories that will not be funded under this announcement:
  • Studies establishing efficacy for a new clinical strategy
  • Pilot studies intended to inform larger efforts
  • Comparisons of patient characteristics rather than clinical strategy options

This PFA seeks projects with budgets up to a total of $2 million in direct costs and with durations of not more than 3 years.

Improving Healthcare Systems (IHS)

Healthcare organizations are under constant pressure to improve systems of care but often lack critical information needed to guide their decisions. So under our IHS priority, we fund studies comparing the effectiveness of alternate approaches that healthcare systems can take to increase efficiency, access to care, and quality, in order to improve outcomes among the patients they serve. Healthcare systems may include individual patients, their families and social supports, providers and care teams, organizations and practice settings, local community resources, and health policies at the state and national level. The latest IHS PFA includes the following changes:

• Emphasizes applications that propose to test the effectiveness of novel uses of technology and incentives rather than a novel deployment of personnel
• Indicates our interest in policies that may affect practice at the systems level (e.g., standing orders implemented at the organizational level)
• Indicates our interest in funding applications that examine systems-level solutions (e.g., the ABIM Foundation’s Choosing Wisely) to address the inappropriate, duplicative, wasteful, or potentially harmful provision of services)
• Permits applications studying novel interventions, not listed in the PFA, that may affect delivery of health care
• This PFA includes a pool of awards for larger, longer studies, with maximum award size of $5 million over up to five years, as well as studies with a maximum $1.5 million in direct costs over up to three years. Applications for the larger studies don’t need prior approval.

Communication and Dissemination Research (CDR)

In today’s fast-paced, complex, and ever-evolving healthcare atmosphere, it’s critical that patients and other stakeholders be equipped with the best available information and tools for making informed decisions. Under our CDR priority, we aim to fund projects that address knowledge gaps in how to communicate and disseminate research findings most effectively. We seek research exploring both communication between clinicians and patients (and their caregivers) as they select among options for care, and dissemination of research results to patients and other healthcare stakeholders. The latest PFA under this priority provides a more comprehensive list of research areas of interest:

• Strategies that increase knowledge on how to communicate complex information to patients and caregivers
• Best practices of dissemination and translation to facilitate shared decision making
• Practices that increase understanding of the tension between strongly held beliefs and contrary evidence and its impact on shared decision making
• Strategies to generate conversations between patients and providers about what is appropriate and necessary treatment (e.g., Choosing Wisely) based on patients’ preferences and conditions
• Strategies to convey uncertainty associated with health and healthcare evidence
• Practices that address contextual factors and their impact on patient-centered communication
• Health literacy- and numeracy-sensitive health communication strategies that relay risks and benefits of health decisions
• Strategies and methods that optimize communication between patient, family/caregiver, and the healthcare team
• Innovative approaches in the use of existing electronic clinical data and other electronic modalities

The PFA also clarifies our limited interest in applications related to decision aids and clinical prognostication tools. Although we will not fund the development and evaluation of new aids or tools, we remain interested in projects that explore:

• The role of established, effective decision aids in implementing patient-centered outcomes research
• The comparative effectiveness of established decision aids in real-world clinical or community settings

Addressing Disparities

Every day, clinicians, healthcare organizations and providers, policy makers, and others are faced with the challenge of eliminating pervasive disparities in health and health care. Previous research has described those disparities and identified potential sources. We seek to fund research that, instead, compares evidence-based interventions to reduce or eliminate disparities in patient-centered health outcomes. The latest PFA issued under our Addressing Disparities priority:

• Includes a new section describing the program’s target populations
• Indicates that applications to study self-management techniques, community health workers or navigators, and cultural or language tailoring of interventions will receive special scrutiny to avoid overlap with other projects or proposals
• Expands explanation of requirements for research comparing an intervention to “usual care”

Please note that requests to increase the budget above $1.5 million in direct costs or to increase the period of performance to more than three years will not be accepted.

Accelerating Patient-Centered Outcomes Research and Methodological Research

How a research study was designed and conducted is critically important in determining the value of the finding to patients and other stakeholders in making healthcare decisions. One of our charges is to improve how patient-centered clinical research is conducted and the infrastructure available for such studies. Under our research methods priority, we are interested in supporting studies that can foster methodological advances in patient-centered outcomes research (PCOR). The latest PFA in this area:

• Increases maximum award size from $750,000 to $1 million in direct costs
• Articulates our intent to advance the science of patient and other stakeholder engagement in research
• Includes a new section on improving methods of recruitment and retention of participants in PCOR trials
• Includes a new section on general analytic methods related to treatment adherence
• Introduces a new Special Topic of Interest focusing on network-based data in research, including methods related to distributed data network analytics and to linkage of data sources

This PFA also revises the previous Special Topic of Interest on patient-centered outcomes and patient-reported outcomes, so that it no longer emphasizes PROMIS-related projects. We will still consider projects that include PROMIS measures, provided they align with the PFA priorities.

In addition, the PFA no longer calls for research on methods for conducting systematic reviews in PCOR for generating, selecting, and prioritizing topics for research. (The latter area may be reintroduced in future funding cycles.)

Improvements and Refinements across All Five Announcements

In addition to the announcement-specific refinements noted above, all five PFAs released in our latest funding cycle require applicants to submit competitive Letters of Intent (LOIs), something that only a few PFAs in previous cycles had required. This means all LOIs will be reviewed by PCORI program staff for responsiveness to the announcement, as well as fit within each program’s strategic goals. We will only consider full applications that we have invited after LOI review. This will reduce the time and effort researchers spend preparing full applications and that we spend reviewing them. We hope these clarifications of our research emphasis will result in strong applications that align with our priorities, so we can efficiently move toward our goal of providing information to help patients and other stakeholders make better-informed health decisions.

Luce served as PCORI’s Chief Science Officer from May 2013 – September 2015