A PCORI Perspective

The Patient-Centered Outcomes Research Institute (PCORI) was established by law in 2010 to fund patient-centered comparative clinical effectiveness research (CER).

As such, PCORI-funded research compares two or more options with proven efficacy, or that are in widespread use, to help inform practical healthcare questions that are important to patients and those who care for them. One of PCORI’s priority areas for research is healthcare delivery, where decision makers often are administrators or other clinical or professional staff within a health system, rather than individual patients.

In this time of experimentation in healthcare, in which administrators are seeking to improve the value of care they provide and improve population-based health management, there is a tension between funding timely and impactful research that is relevant to the choices health systems administrators need to make and having enough evidence to ensure that a research question is CER-ready. As we look to the future, PCORI is interested in reducing the lag between innovation in care delivery and broader impact on the health system.

Given the Donaghue Foundation’s goal of “making research relevant and ready,” and the common goal that investments should have practical impact, PCORI funding could represent a natural extension for Donaghue Foundation grantees. Below, we offer suggestions about evaluative data that could be collected to build a bridge between the innovative Donaghue Foundation pilot projects and PCORI’s funding mechanisms, and to improve projects’ readiness for CER.

First, the Donaghue Foundation’s commitment to encouraging partnerships between researchers, entrepreneurs, and healthcare systems is consistent with PCORI’s commitment that patient and stakeholder engagement be woven into project design and execution. At the project design phase, it is important to document why the identified research question is important to key decisionmakers, including patients, caregivers, and clinicians.

Second, while a project may focus on process outcomes, consider whether there may be preliminary data one might collect on clinical patient impact. Such data could provide preliminary information on intervention efficacy for end points important to patients, while laying the foundation for future CER studies.

Finally, consider collecting qualitative data, which can provide invaluable insight into the relative ease or difficulty of introducing the studied intervention into the health care system. While both PCORI and the Donaghue Foundation are interested in impact, understanding what is needed to sustain or spread findings in multiple healthcare systems is particularly important in making the case for CER.

Numerous commonalities exist between the Donaghue Foundation’s priorities and PCORI’s areas of interest. PCORI is currently funding initiatives in areas historically supported by the Donaghue Foundation, such as Choosing Wisely®, palliative care, and opioids research. The Donaghue Foundation is also interested in models or approaches that remedy the disproportionate impact of poor quality, low value care on vulnerable populations, or enhance vulnerable populations’ access, use, and benefit from quality care. These topics, framed as studies to compare models of care, are good candidates for CER research and are also of interest to PCORI. Finally, the Donaghue Foundation’s current focus on nursing home care presents opportunities for research in an area that PCORI has not yet made a substantial investment.

Ultimately, PCORI’s impact will be measured by whether its funded research changes medical practice and provides patients and those who care for them with information that helps them make better-informed healthcare decisions. Both organizations’ missions and impact could be enhanced by clarifying the pathway between innovative pilot work (like that funded by the Donaghue Foundation) and CER, creating opportunities for evolution in healthcare.