The Affordable Care Act created an independent organization to support research that assesses which healthcare interventions are most effective. But three years after it started funding studies, there's no central repository of results or a clear strategy for making sure the knowledge reaches the clinicians it's intended to influence.
The Patient-Centered Outcomes Research Institute distributed grants worth $30 million to its inaugural round of 50 projects. About 30 are complete and more results are anticipated this summer, PCORI leaders told Modern Healthcare.
It's not clear, however, when or where those results can be found. PCORI says grantees are expected to have a plan for sharing their findings but also that it does not set timelines for completing studies.
As of last week the group said it had not been notified by project leaders of the completed research whether or not they have submitted manuscripts to peer-reviewed journals. The institute also said it does not have a central database where results can be shared, and researchers are not required to submit manuscripts to journals for publication.
PCORI has now approved $845 million in funding for nearly 400 projects, and the latest round came April 21. The organization announced $120 million in funding for 34 comparative clinical-effectiveness research projects, including five pragmatic clinical studies.
While some of the initial projects were criticized as too trivial to meaningfully inform clinical practice, the new studies address a wide range of important and controversial clinical questions, including use of radiation therapy for breast cancer, effective treatments for bipolar disorder, and lifestyle interventions versus drug therapy for diabetic patients.
The results, experts say, are at risk of getting lost in the same black hole often noted of traditional clinical data, which often remains unpublished or unreported long after studies are completed.
Without a robust system for dissemination, the idea of “a cumulative evidence base is just a metaphor,” said Lynn Etheredge, director of the Rapid Learning Project, which promotes the concept of analyzing electronic patient data to fuel continuous improvement in safety and quality.
The availability of comparable, computable and combinable data dramatically improves the worth of the studies and is “part of the public accountability for a research agency,” Etheredge said.
PCORI's hands-off approach to results may simply reflect what's known as the Inglefinger rule, the long-standing policy of the New England Journal of Medicine that discourages the sharing of data before it has been published, suggested Michael Millenson, president of the Highland Park, Ill., consulting firm Health Quality Advisors.
But, he said, there needs to be “imaginative rethinking in the deployment of resources” to ensure the efficient, effective and rapid translation of research into clinical practice. “Frankly, given the amount of money they have, that's something that perhaps needs to be a greater priority,” Millenson said.
In January the Institute of Medicine urged major changes in data-sharing practices for clinical trials, including suggesting specific timetables for releasing adverse-event summaries and analyzable data sets that make it easier for independent researchers to compare costly therapies.
In an editorial published after the release of the IOM report, Dr. Jeffrey Drazen, the NEJM editor-in-chief, noted that the way data is thought about needs to change. “We need to view it as a community resource, much like a shared park, rather than as personal property,” he wrote. Drazen told Modern Healthcare that PCORI's dissemination of its comparative-effectiveness data “is an area we are watching.”
PCORI, meanwhile, says it is nearing the end of the first phase of development of an infrastructure called PCORnet, which is essentially a network of networks providing access to information from electronic health records, claims data and other sources. The participants will have the capacity to share their findings through the network.
The first study in that project, expected to begin this summer, will compare the effect of different doses of aspirin for the prevention of heart attack and stroke among people with heart disease. The early PCORnet projects will help “illustrate PCORnet's wide-ranging capabilities and pave the way for future research,” the institute said.
As the challenges associated with gathering and sharing clinical data persist, both among traditional clinical trial research and emerging comparative-effectiveness studies, Millenson, says it's important to not lose sight of the goal.
“The reason to do research in this field is to help people,” he said. “The key is to make sure research results are translated into helping change patient care as quickly as possible.”