PCORI: Three Years of Progress and a Foundation for the Future
Three years ago today, PCORI’s Board of Governors was appointed by the Comptroller General of the United States. At the time, the Patient-Centered Outcomes Research Institute was just a vision, written into the Patient Protection and Affordable Care Act to address a major challenge to improving patient care. That challenge – the lack of sufficient, evidence-based information to answer a myriad of questions faced by patients and other clinical care decision makers every day.
Our job is to close this evidence gap by identifying critical unanswered questions, funding comparative clinical effectiveness research (CER) to address them, and disseminating the results. From its first meeting, PCORI’s Board of Governors has recognized and emphasized the importance of meaningful engagement and guidance by patients and a broad range of other healthcare stakeholders as we develop, conduct, and disseminate rigorous research. We believe the community’s involvement throughout the research process will help to produce the relevant, reliable and trustworthy information patients need to make more informed decisions about their health and health care.
In three short years, we have much to celebrate. We have established national priorities for research and patient-centered research agenda. We continue to build a portfolio of patient-centered CER projects based on this agenda. Our Methodology Committee has established methods standards for the conduct of such work. We’re developing a large and diverse community of engaged healthcare stakeholders, and are putting into place the infrastructure to support efficient, high-quality, impactful, and useful research studies –funded both by PCORI and others – for years to come. I’d like to take this opportunity to reflect on our work to date and the path ahead.
Building Our Research Portfolio
As directed by our authorizing legislation, PCORI’s chief responsibility is to fund comparative effectiveness research that helps the healthcare community make better- informed decisions that will lead to more effective, higher-quality care. We’ve already approved 197 funding awards totaling $273.5 million to researchers in 36 states and the District of Columbia. By the close of 2013, PCORI will have committed more than $400 million in research funding. Next year, we expect to award nearly $500 million.
To date, the majority of the research awards we’ve made have come in response to PCORI Funding Announcements (PFAs) associated with our five broad National Research Priorities and our Research Agenda. Such studies examine a wide range of illnesses that occur commonly in the United States and result in heavy burdens on patients, families and the healthcare system, including cancer, mental illness, cardiovascular disease and other highly prevalent conditions.
We also are directed to pay particular attention in our work to vulnerable populations, which are typically underserved by research. Racial and ethnic minorities, older adults and rural residents are among the groups facing unique health challenges – whether it’s high risk of cardiovascular disease in the Appalachians or poor outcomes among people of color who are mentally ill – that must be addressed through projects specifically designed to account for population-specific differences.
A Unique Approach to Research
We build a role for stakeholders from across the healthcare community – scientists, patients, caregivers, clinicians, payers, policymakers, industry, employers and others – into every major initiative and into each phase of the research process. From helping us determine which topics to study, to conducting the research and sharing the results, engaging patients and other stakeholders is critical to our mission to produce information that is responsive to and reflective of the needs of the communities we serve.
Our process for producing funding announcements that focus on particular high-impact topics reflects the value we place on involving a broad range of stakeholders in our work. We seek recommendations from across the healthcare community about the research topics or questions we should consider funding. This stakeholder-initiated process is helping us to concentrate ever-greater amounts of funding in areas judged to be of high priority by patients, caregivers, clinicians, and others within the healthcare community.
We already have evaluated and prioritized hundreds of such questions through an iterative process informed by a series of multi-stakeholder PCORI Advisory Panels and have started issuing “targeted” funding announcements as a result, including uncontrolled asthma and prevention of injuries due to falls in the elderly. We expect to issue more of these topic-specific announcements in coming months and on into 2014.
Another example of the patient-centered approach we have developed over the past three years is the way we evaluate research proposals, using unique criteria and processes. We require applicants to include representatives of relevant patient and other stakeholder communities on their research teams, and judge proposals on the quality of their engagement plans as well as their scientific rigor and likelihood to change practice. The evaluation itself is conducted by review panels that include scientists as well as patients and other stakeholders, who ensure that a broad healthcare community perspective is always represented.
We are confident that by involving the end users of the results of our work throughout the research process, the findings of the studies we fund are more likely to be used in everyday practice.
Setting a Foundation for the Future
Even as we can be proud of what we’ve achieved in our first three years, we know we have more to do.
We’re now entering what will be not only our most intense and focused period of research investment but a time that will see our funded investigators start to report to the healthcare community the initial results of the work we’ve supported so far. We expect to start seeing the results of our Pilot Projects by mid-2014 and of our first round of primary research studies about 18 months after that. A critical next step is working with our stakeholder partners in disseminating our research findings – when these findings merit dissemination. Again, we are convinced that being engaged with our stakeholder communities will help to ensure that findings are disseminated – and implemented.
We’ll continue to refine the way we pursue engagement by patients and other healthcare stakeholders as a tool to rigorous comparative research and, we expect, be able to start reporting in detail about the impact that “research done differently” appears to be having. Indeed, our greatest contribution to the research enterprise might not just be in the studies we fund but in showing the value and impact of a new, more patient-centered approach to CER.
We’ll also be working to disseminate and promote the adoption of the 47 standards that our Methodology Committee developed and that our Board adopted for conducting patient-centered research that applicants can use as a guide when seeking PCORI funding. The standards are designed to ensure that the research we fund is scientifically rigorous in addition to being responsive to the questions patients face in real-world clinical settings. We are already beginning to see researchers become more fluent in these standards; our most recent funding cycle offers evidence of that.
And we will keep working hard to improve the way we do business, counting on input from our applicants, awardees, and the entire healthcare community – complementary and critical. Although designed to become a prominent national research institute, PCORI was established three years ago essentially as a start-up organization. Starting with a blank slate, PCORI is now emerging as a leading funder of healthcare research.
We hope that you’ll join us in celebrating PCORI’s accomplishments. But more importantly, we hope you’ll get involved in our work and help us improve – through research and dissemination – the quality of care each of us receives.