PCORI is credited as part of the inspiration for a Patient Engagement Advisory Committee at the Food and Drug Administration (FDA) Center for Devices and Radiological Health. The creation of this FDA committee was informed by PCORI’s Patient Engagement Advisory Panel and the PCORI Engagement Rubric, which serves as a framework for stakeholder input on PCORI decision making.
PCORI's approach to comparative clinical effectiveness research (CER) considers patients’ and other healthcare stakeholders’ needs and preferences, focusing on outcomes most important to them. This patient-centered, stakeholder-driven approach not only shapes the research that PCORI funds, but also influences changes in the culture of healthcare research more broadly. Here are some specific examples.
The Centers for Medicare and Medicaid Services (CMS) used the PCORI Engagement Rubric to guide its efforts to partner with patients to develop quality measures. The CMS Quality Measure Development Plan states, "Recent best practices identified for partnering with patients and caregivers include: adopting principles from the (PCORI) person-family engagement framework..."
PCORI inspired Debra Fiser, the former dean of the College of Medicine at the University of Arkansas for Medical Sciences, to establish a center for patient-centered pediatric CER in 2014. It recruits and mentors early-career faculty. "When I discovered PCORI’s approach to funding patient-centered CER, I used that as a catalyst to convince the medical school to invest in a training center," Fiser said.
PCORnet, The National Patient-Centered Clinical Data Research Network, provides infrastructure that enables the conduct of large and unique studies, including those supported by other funders. For example, a large NIH-funded trial, the PREVENTABLE study, is recruiting from 40 healthcare systems in seven PCORnet Clinical Research Networks to answer important questions about dementia prevention.
Because of the large size of this study, we may identify subgroups of older adults most likely to benefit from taking statins to prevent dementia, disability, or cardiovascular disease… the large, diverse study population will also enable us to better evaluate unwanted effects of statins that may put some at risk or reduce their quality of life.
Patient and Other Stakeholder Engagement in Research
Influenced by PCORI, Geisinger Health System developed a strategic vision for patient engagement in research. Geisinger has adopted a framework for patient and family engagement in discovery, as well as in care. It has also established a standing advisory group on patient and family engagement.
The Henry Ford Health System Patient Engagement Research Center (PERC) credits PCORI with serving as a model for patient engagement. The center supports patient-centered outcomes research at the health system and improves the way it delivers care. "PCORI’s support, resources, and guidance have been key to PERC’s success," said Karen Kippen, PERC’s Executive Director.
PCORI inspired the American Heart Association to pilot the Citizen Scientist Think Tank, which fosters patient engagement in the design of research on heart disease and stroke.
Researcher Training in Community Engagement
The Meharry-Vanderbilt Alliance credits PCORI with catalyzing its developing two new programs to train doctoral students and postdoctoral research fellows in community engagement in research. Said the Alliance’s Executive Director Consuelo Wilkins, "The motivation of researchers because of PCORI funding has been a big stimulus for the work that we do.… The availability of PCORI funding and the interest was a catalyst for us to be able to expand our reach."
PCORI motivated new opportunities at the University of Texas Health Science Center at San Antonio. The university created one-year Clinical Investigator Kickstart awards to fund meaningful engagement with partners to increase knowledge about and skills in research engagement.
The University of Pittsburgh and University of Pittsburgh Medical Center credit PCORI with being central to establishing their Comparative Effectiveness Research Center (CERC). The center developed courses based on The PCORI Methodology Standards and emphasizes stakeholder engagement. Said Monica Costlow, CERC project director, "These are new concepts for some of our researchers—PCORI is making them think about the stakeholders."
As PCORI has evolved, the notion of patient engagement has changed dramatically, and the AHA has sought more ways we can make the patient the focal point.
Patient and Other Stakeholder Review for Funding Decisions
PCORI inspired the addition of patient reviewers and new review criteria for grant programs at multiple institutions, such as the Vanderbilt University Medical Center, the Ontario Ministry of Health and Long-Term Care, and the Michigan Institute for Clinical and Health Research. "With the addition of [a] PCORI [ambassador] to our cabinet, we have really been trying to be more connected to patients and others in the community and community organizations," said Kate Althouse, the institute’s program manager.
Patient and Stakeholder Partner Support
PCORI inspired multiple institutions, including the University of Texas Health Science Center at San Antonio and the University of Arkansas for Medical Science, to develop policies and programs to make engagement easier. Examples include new policies to permit hiring patient or stakeholder partners as study staff and other capacity-building services.
Methodology Standards in Research
The Association of University Radiologists' Radiology Research Alliance Task Force on patient-centered outcomes research reviewed all PCORI-funded radiology projects and described how the The PCORI Methodology Standards apply to medical imaging. The task force identified opportunities for future projects in the field and developed a national agenda for patient-centered outcomes research.
The PCORI Methodology Standards have also shaped courses at several institutions, including Harvard University’s T.H. Chan School of Public Health, University of Pennsylvania’s Perelman School of Medicine, and an AHRQ-funded training at the University of Pittsburgh, Expanding National Capacity in PCOR through Training, designed for minority-serving institutions.
Academic Journals on Healthcare Research
In an interview on becoming editor in chief of the American Journal of Kidney Diseases, Harold Feldman highlighted major studies related to nephrology that PCORI is funding. He said the journal would focus on translating findings from patient-centered outcomes research into clinical practice.
PCORI work inspired SLEEP, the journal of the Sleep Research Society, and the Journal of Clinical Sleep Medicine to require authors to use people-centered language in their publications.
PCORI has made overt what was actually true all along: That meaningful medical research is by definition a collaborative effort.
Other Examples of PCORI's Influence on Health Research?
Are you aware of other examples of PCORI's influence on any aspect of health research? We invite you to share any examples you have observed in your own work or that of others. Email us at [email protected].
Posted: February 12, 2018; Updated: May 1, 2020