BY Gregory Twachtman

The Patient-Centered Outcomes Research Institute board of governors approved two actions that are expected to form the foundation of its future work: conducting environmental scans and developing the process for awarding “tier 1” grants.

The actions are related in that they both aim at understanding the infrastructure and information available around comparative effectiveness research.

The board reached the decision during its March 7-8 meeting in St. Louis. In a March 7 presentation to the board, member Richard Kuntz, senior VP and chief scientific, clinical and regulatory officer at Medtronic, noted that funds available for the tier 1 grants will be used “to inform development of national planning priorities. This is our job one, something we want to do as a board for this year. Almost all of our activities at least at this stage are focusing towards informing these national priorities.”

The grants will help develop information alongside the environmental scanning, which Kuntz said will “help PCORI determine where it can add unique value and to help PCORI establish the national priorities.” An emphasis is being placed on patient and other stakeholder engagement as part of the process.

Defining “Patient-Centered Outcomes Research”

However, before getting to the grant process, Kuntz raised the question of developing a clear definition of “patient-centered outcomes research.” The term itself was the result of an effort by Senate Finance Committee Chairman Max Baucus, D-Mont., to rein in the controversy caused by the term “comparative effectiveness research” during the health care reform debate (“Baucus Takes ‘Patient-Centered’ Focus For Comparative Effectiveness In Bill,” “The Pink Sheet,” June 15, 2009). But with the question being raised, it is clear the board does not necessarily see PCORI as synonymous with CER.

In describing the tier 1 grants, Kuntz said that first “we want to frame, working closely with the methodology committee and other committees of our board, on what ‘patient-centered’ and ‘outcomes research’ is,” noting there are a variety of definitions, and PCORI might want to “sharpen” what exists “with respect to what our needs are.”

He said there is no consensus on what “patient centeredness” means. “That is something we can develop as a group. Once we get that frame, we can solicit projects under that frame that still allow for a lot of variability and latitude for individuals and investigators to be creative, to explore unmet patient needs.”

Kuntz laid out five areas the committee will be looking at as it completes its environmental scans: ongoing comparative effectiveness research; peer-review processes that engage stakeholders; patient-centered priority setting processes; outcomes clinical research capacity and capability analysis; and an overview of research funding by the American Recovery and Reinvestment Act.

The peer review process involves the committee taking a different approach than what is traditionally thought of as peer review, Kuntz explained. “When one talks about peer review processes, one often thinks about experts who sit together in a room and decide and rank projects as they go forward,” he said. “We want to come up with something different than the traditional expert system. Since we want to focus on the patients and look at the entire health care continuum, we want to bring all the stakeholders into the process of peer review – those individuals who will value proposed research projects we may fund.”

However, how that kind of process would work is unclear at the moment, Kuntz noted, adding that “we are very curious and anxious to get information on what peer review processes that engage multiple stakeholders are, what are the best practices, and how can we adopt them for our purposes?”

Part of the environmental scan also will focus on research methodologies in an effort to collect best practices rather than embark on developing them.

“Once the needs of patients are understood, how do we take our methodologic experts and shape methodologies around those needs, as opposed to trying to come up with cutting-edge methodologies and statistics or observational research and trying to see how that fits into a research agenda.” Kuntz noted. “Part of our scan is going to first focus on the needs and … come up with creative ways to shape the methodologies around those needs.”

Early Budget Framework Detailed

Also presented at the meeting on March 8 was a glimpse into the financial position of the institute.

Pat Nichols, interim executive at Transition Management Consulting, a firm contracted by PCORI, presented a basic budget. It allocates $22 million of the $50 million available to PCORI for the 2011 calendar year, including $2.3 million to the Public Affairs and Communications Committee, $1.1 million to the Methodology Committee, and $1.4 million for the Program Development Committee. Additionally, there is $13 million for grant-making capacity initiatives.

“It was not our intent to take the $22 million and just allocate it the different committees, but rather allow the committees to do their work first in developing their work plans, developing their objectives, and allow the Finance and Administration Committee some time to begin to figure out how to resource that work,” Nichols said. “These are placeholders more than they are allocations,” adding that more money could be allocated as needed.