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By Nathaniel Weixel
A comparative effectiveness entity set up by the health reform law will initially focus its research on broad topics and will not single out any specific diseases or conditions, according to the organization's draft agenda for research priorities, released for public comment Jan. 23.
The National Priorities for Research and Research Agenda will be used to guide funding announcements for comparative clinical effectiveness research that will give patients and those who care for them the ability to make better-informed health decisions, the Patient-Centered Outcomes Research Institute (PCORI) said in a statement.
The 53-day public comment period, which will end March 15, will be used to solicit feedback and revise the priorities and agenda before a final version of each is adopted by PCORI's Board of Governors.
The comparative effectiveness research (CER) mandate in the Patient Protection and Affordable Care Act established PCORI, an independent entity, to oversee and set national CER guidelines. CER is designed to inform health care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options for different patients.
The organization is tasked with sponsoring scientifically rigorous studies to assist patients, clinicians, payers, and policymakers in making informed health care decisions. PCORI will provide consumers with information they can use to guide their treatment decisions. If successful, CER will lead to better health outcomes and lower costs.
Under the health law, PCORI will have an estimated $3 billion over the next 10 years to fund clinical effectiveness research.
“Ultimately, decisions about funding will depend on the quality of applications—with special attention to the likelihood that the research may lead to improvement in patient outcomes, as determined by alignment with PCORI criteria,” the group said in its agenda.
CER has been on policymakers' agenda for a number of years, and the enactment of both the American Recovery and Reinvestment Act of 2009 and PPACA reignited the federal government's interest in CER.
Some Republican lawmakers have expressed concerns over CER being used to ration care, and a report from the Deloitte Center for Health Solutions released last summer also noted that a national CER effort provokes fears of rationing from consumers (124 HCDR, 6/28/11).
Initially, PCORI said it will focus its research on five categories:
• comparisons of various treatment, diagnosis, and prevention options;
• improving health care systems by focusing on ways to improve access to care, patient self-care, and the use of nonphysician providers;
• communication and dissemination of research by focusing on using tools like electronic health records to expand patient and physician knowledge;
• addressing and overcoming health disparities across different patient populations; and
• accelerating the country's patient-centered and methodological research by using registries and clinical data networks to support the research.
To develop the initial National Priorities for Research, PCORI in the draft said it reviewed nine previous national efforts to prioritize comparative effectiveness research and related health care activities, including efforts by the Institute of Medicine, the National Pharmaceutical Council, and the Agency for Healthcare Research and Quality.
PCORI said that by design, the draft agenda and priorities list does not cover all the activities that the board sees as part of its mission. “This document is the foundation upon which the first set of PCORI funding announcements will be developed,” the organization said. The institute “intends to be a learning organization; it will continue to evolve as it gains experience.”
PCORI Executive Director Joe Selby also explained that the agenda was deliberately broad. “This initial agenda does not limit which conditions or treatments will be studied. It is a starting point,” Selby said in a Jan. 23 statement. “We hope that patients and other stakeholders will join with us in the coming months as we apply this framework to identify the specific questions that are most important for PCORI to address. We will be asking the community to think boldly about research projects across all five priority areas.”
The draft research agenda noted that “at this early stage of its work and of patient-centered outcomes research as a discipline,” PCORI does not want to focus on a narrower set of questions or health conditions, nor does it want to exclude any diseases or conditions.
“Over time, we anticipate that PCORI will develop a research portfolio that includes both broad calls for proposals as well as contracts or grants targeted to high-priority conditions or treatments identified from public input, dialogue with stakeholders, and public needs,” the organization noted.
After reviewing the public feedback received, PCORI will publish a report that summarizes the input with an explanation of how it led to changes in the draft priorities and agenda. The PCORI board of governors then must adopt the priorities and agenda before it can issue primary funding announcements.
PCORI will issue its first funding announcements in May.
PCORI said it will conduct additional forums to obtain and incorporate more public feedback on the draft national priorities for research and research agenda. The outreach efforts will include focus groups, involving patients, caregivers, and clinicians, as well as a national forum on Feb. 27 in Washington.
More information is at http://www.pcori.org/assets/PCORI-Draft-National-Priorities-and-Research-Agenda2.pdf.
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