The Patient-Centered Outcomes Research Institute (PCORI) was created to provide patients and those who care for them with the information they need to make better-informed healthcare decisions – information that addresses concerns patients have but that often aren’t considered in traditional research.
So how do we generate such information? We start by identifying and selecting research topics that address the questions patients, caregivers, clinicians and other healthcare stakeholders deem most important. This differs from the way clinical research is often conducted, where investigators come up with the questions to be studied. But we’re convinced it’s the way to produce results that will be most useful and relevant to those facing critical health and healthcare decisions.
I join six colleagues in describing how we at PCORI plan to generate and prioritize the questions that we’ll ask researchers to study in a newly published Health Affairs article, “How The Patient-Centered Outcomes Research Institute Is Engaging Patients And Others In Shaping Its Research Agenda.” The article is part of a special Health Affairs theme issue on patient engagement. One of those colleagues, PCORI Executive Director Joe Selby, MD, MPH, discussed our paper at a PCORI-supported briefing that Health Affairs held on February 6.
Building on the work of others, we’ve embarked upon two complementary methods to ensure that the voices of patients and stakeholders are represented in our selection of research questions and meaningfully reflected throughout the research process.
The first method invites researchers from around the country to join with patients and other stakeholders in responding to our broad funding announcements, which we first issued last May. All applicant teams must involve patients and stakeholders in each step of their research to be considered. They are also required to explain why the research question they propose to study is patient-centered and likely to improve decision-making and patient outcomes. We strictly follow these criteria in making funding decisions, with the expectation that the resulting research will echo our commitment to support patients in real-world decision making.
This approach led to our approval in December of 25 research awards totaling $40.7 million dollars over three years. The projects include those that will study ways to improve care for people with a variety of health problems, including bacterial and viral infections, mental illness, cardiovascular disease and stroke. Other projects seek opportunities to improve patient-clinician communication, reduce selected health disparities, and improve the way healthcare systems operate.
Our second method focuses on selecting specific research questions by asking key stakeholders — including patients, caregivers, clinicians, policymakers and others — to directly suggest the questions that matter most to them. Questions that fit our mission, fall within our research priorities, and have not been answered by existing research, will be forwarded to our newly established PCORI Advisory Panels for further review. The panels will evaluate questions and prioritize them based on patient-centered standards drawn from our authorizing legislation. Lists of prioritized questions will then be provided to our Board of Governors for final selection.
We pilot tested this approach with 35 patients, caregivers and other stakeholders last fall. The pilot culminated in a December workshop that reviewed the results and discussed methodological issues in research prioritization. We will start implementing this prioritization process later this year as a path to creating targeted funding announcements that will directly address patient and stakeholder-generated questions.
PCORI remains a work in progress, but as a stakeholder-driven organization with enormous public responsibilities, we are committed to building our research enterprise in an open, transparent and collaborative manner. The Health Affairs article is an important part of our effort to inform you and the entire healthcare community about our strategy for patient-centered research. The issue includes two additional pieces — one on engaging mental health patients in research, which was co-authored a Ming Tai-Seale, PhD, MPH, a primary investigator on a PCORI pilot project, and another on spreading decision aids in primary care settings, which was co-authored by Dominick Frosch, PhD, a former primary investigator on a PCORI pilot project – that provides a demonstration of the patient-centered research PCORI is fostering.
Our efforts to meaningfully integrate the voices of patients and other stakeholders into the research enterprise support our commitment to “research done differently” – putting patients’ concerns at the center of the process of producing evidence that will lead to better outcomes. We hope you‘ll take the time to read the article, which further describes our approach, the challenges we face and the work of others in this area, and provide us with your feedback.
Rachael Fleurence, PhD, is Acting Director of PCORI’s Patient-Centered Outcomes Research (PCOR) Methods program.
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