"What is the most effective way to treat, or prevent, this medical condition?"
The simple question weighs on the minds of countless patients and their healthcare providers daily. Yet because the bulk of medical research to date has been largely driven by the interests of researchers or pharmaceutical companies, definitive answers in many cases remain hazy.
In an effort to provide evidence-based explanations for patients, providers and payers, the Patient-Centered Outcomes Research Institute (PCORI) was authorized as part of President Obama's Patient Protection and Affordable Care Act.
With a specific focus on comparative-effectiveness studies and research procedures that involve patients, caregivers and clinicians in every facet (from idea generation through findings dissemination), the nonprofit has set the stage for truly patient-centered outcomes research.
Just three years in, the organization has already awarded more than $464 million to fund 279 studies and projects. Over the next two years, it's expected to bestow $1.03 billion more.
With the institute's emphasis on efficiency, those involved in PCORI expect it won't be long before its findings begin to drive healthcare practice. And with nursing's emphasis on patient-centered care, it's only fitting that nurses have played a role in driving PCORI from the start.
"Since it was first constituted Sept. 23, 2010, I have been actively attempting to get nurses involved," said Debra Barksdale, PhD, RN, one of 21 members of the institute's board of governors, appointed by the Government Accountability Office (GAO). "This is something that will definitely impact nurses across all levels. It's something we should keep our eye on."
Comparative-effectiveness research gets to the heart of what patients want to know: which treatments work best? By funding comparative-effectiveness research exclusively, PCORI aims to boost the quality of healthcare while cutting its cost.
The initiative isn't cheap.
Through September 2019, when the institute is currently slated to sunset, PCORI is budgeted to receive some $3.5 billion in funding (the bulk of which must support research and research-related activities).
Some of the funding comes from the U.S. Treasury and the rest from a small annual fee assessed to Medicare, private health insurance and self-insured plans -- $2 per covered person in fiscal year 2014 and at a rate adjusted for increases in healthcare spending thereafter.
As one of the inaugural members of the PCORI board, Barksdale has been involved in building the institute since its establishment.
"We had our first conference call a week after we were appointed. We were 21 people who didn't know each other. There was no infrastructure, no building, no address. Just this legislative mandate," recalled Barksdale, who is an associate professor in the school of nursing at the University of North Carolina at Chapel Hill and also immediate past president of the National Organization of Nurse Practitioner Faculty. In addition, she volunteers as a family nurse practitioner in a clinic for people who are homeless. "We all had full-time jobs, but we did whatever we could to set this organization in motion."
Through phone calls, emails and in-person meetings, the board has made steady progress since the fall of 2010. Today, PCORI is supported by a staff of more than 100 people in its Washington, D.C. office.
Ensuring Research Quality
Four months after Barksdale's appointment, to the Board of Governors by the GAO, Robin Newhouse, PhD, RN, NEA-BC, FAAN, accepted the GAO appointment to the institute's methodology committee. The committee is dedicated to developing methodology standards for the types of studies PCORI funds, comparative clinical effectiveness research. These standards help to ensure that studies funded by the organization are designed and carried out in a way that is scientifically valid.
"We began our work together in January 2011, with the task to generate the first set of comparative clinical-effectiveness research standards by May 2012," remembered Newhouse, who is chair and professor of organizational systems and adult health at the University of Maryland School of Nursing in Baltimore. "Today, those minimal standards are required for all studies funded. Our hope is that these standards will be widely followed, and refined by other funders."
The methods standard, Newhouse explained, boost the quality of the research and its subsequent acceptance of results in practice settings.
Last August, the PCORI board appointed Newhouse to chair the methodology committee. And earlier this year, Barksdale was tapped to chair the engagement, dissemination and implementation committee. One of three strategy committees of the board of governors, the committee is charged with advising how to best speed the dissemination and implementation of research findings.
"I think it's pretty wonderful to have a nurse chairing one of the board of governors' three major committees and also to have a nurse chairing the methodology committee," Barksdale said. "It's exciting."
Providing Advice, Receiving Research Funding
Nurses are involved in other arms of the institute as well.
"We have nurses participating in the merit review process, serving on our advisory panels, and applying for our research funding - which is really good," said Barksdale. "And they have been successful."
Advisory panel members provide recommendations to PCORI staff, board members and committees on a number of subjects.
A handful of nurses currently serve on panels created to offer input on research aimed at improving healthcare systems, addressing disparities, engaging patients, and assessing prevention, diagnosis and treatment options.
(Margaret Clayton, PhD, RN, co-director of the PhD program at the University of Utah, Salt Lake City, co-chairs the latter advisory panel.) A number of nurse researchers have received PCORI funding (see box).
The patient-centeredness of both the nursing profession and the institute situates nurses as natural funding candidates, Newhouse observed.
"Nurse researchers naturally have high synergy with the PCORI areas of interest," she said, "and often have experience in sustained partnerships with patients and families, which is necessary for PCORI studies."
Mulling Merit, Spreading the Word
As a merit reviewer for the institute, Deborah Hunt, PhD, RN, associate professor of nursing at the College of New Rochelle, New Rochelle, N.Y., evaluates and provides feedback on applications for PCORI research funding. Her role covers two steps of a three-step application review process.
First, she completes an online review, assigning scores to applications based on criteria outlined by the institute. Second, she attends an in-person meeting with dozens of other merit reviewers (clinicians, scientists, patients, caregivers and others), where the highest-scoring applications are reviewed and discussed. After that, a board selection committee decides final funding awards based on merit reviewers' scores and discussion.
"The in-person meetings are very enjoyable and informative," said Hunt. "You meet lots of interesting people. And because you are hearing input from so many stakeholders, it is common for something to come up during the discussion that you hadn't thought about before."
To date, Hunt has participated in two merit reviews - one to evaluate proposed merit review processes and one to review applications for funding. She recently submitted her name as a possible reviewer for a third time this summer.
"I'd love to do it again," said Hunt, who has recently completed training to act as a PCORI ambassador. Ambassadors volunteer to spread the word about the importance of the institute and the patient-centered outcomes research it supports, although they don't officialy work for or represent PCORI.
"It's such a valuable organization," she said. "It's my hope that even more nurses will want to get involved. As nurses, we have such wonderful insight, expertise and experience. We really need to join together and take a more active role in the future of nursing and healthcare."
Through PCORI, these nurses believe they can do just that.
Jolynn Tumolo is a freelance writer.