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Institute: PCORI Must Seize Leading Role in Spreading Findings on What Works in Medicine

By John Reichard, CQ HealthBeat Editor

February 16, 2011 – A "thoughtful and aggressive" policy to turn research findings into improved medical treatment will be critical if the nation is going to get better value for its health care dollar, according to a new paper from a broad array of health system stakeholders.

And the Patient-Centered Outcomes Research Institute (PCORI)—created by the health care law to oversee "comparative effectiveness research"—should become a "highly visible champion" for disseminating that research, says the paper from NEHI, formerly the New England Healthcare Institute.

NEHI members include AARP, the Advanced Medical Technology Association (AdvaMed), Wellpoint, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the American Cancer Society-New England.

Research identifying superior methods of treatment may take years, if not decades, to bring major change to the practice of medicine. Slow adoption has remained a problem even as research on "evidence-based medicine" has grown steadily in recent years.

Now with the health care law (Pl 111-148, PL 111-152) pumping hundreds of millions of dollars into comparative effectiveness research in hopes of helping to control the growth of health care spending, "dissemination" is a growing preoccupation of mediresearchers under the gun to demonstrate a payoff from the big flow of money into their field.

"PCORI is well positioned to seize a public role in comparative effectiveness research dissemination in a way that other organizations, including the Agency for Healthcare Research and Quality, are not," the NEHI paper says.

The Agency for Healthcare Research and Quality (AHRQ) is a federal agency that conducts extensive research into various aspects of health care delivery. The agency has a major program to disseminate the findings of comparative effectiveness research but tends to adopt a low profile in that regard because of past controversies raised by medical groups disadvantaged by its conclusions.

AHRQ has come under fire over the years for promulgating "cookbook" medicine despite its strategy of simply making research findings available to the public, including insurers and provider groups.

NEHI says that "as a line agency of the government, AHRQ is less well positioned to claim a highly visible public role in promoting comparative effectiveness research dissemination when the very legitimacy of the new CER program is still disputed by opponents."

Critics of the health care law have charged that the research will be used to ration care. Defenders say it will help patients and doctors make joint decisions on the best treatments for the particular condition involved.

"As an independent nonprofit organization PCORI can operate at arm's length from government agencies and government policies. Its board of governors includes multiple interests (patients, providers, manufacturers, payers and others) and includes several with expertise in the health and health care of minority groups and small patient populations," the NEHI paper says. "Thus, PCORI is positioned to become a trusted authority on comparative effectiveness research."

NEHI emphasizes that an "expansive view" must be taken of dissemination. "New research findings rarely leap from a journal article straight into clinical practice," the paper says. "Intermediary groups" such as medical societies "typically play an enormous role in translating medical evidence and taking a position on how it should be utilized in the form of medical guidelines," it adds. PCORI should build "diverse partnerships" to spread findings, including with national medical societies and patient groups.

Dissemination considerations should also influence how PCORI shapes the design of studies. "The choice of research end points or reported outcomes may make a great difference in whether the findings prove relevant to patients," NEHI says. Typically studies look at whether patients survive, for how long, and how well, but other considerations also influence whether findings affect clinical practice. Thus studies showing how fast patients can return to work after a particular treatment or whether they will be able to care for children are also important.

The paper also says PCORI should strive to "reinforce public understanding" of comparative effectiveness research and link it to major health conditions that affect broad cross sections of the population.

PCORI's attempts to elevate its profile may spur criticism that the government is trying to meddle in health care. The institute is targeted for elimination under legislation introduced by Rep. Thaddeus McCotter, R-Mich.

But NEHI Executive Director Valerie Fleishman emphasized in an interview that PCORI "was purposefully set up not as a government agency" but as an independent group. None of its board members are affiliated with the government, she said. That arms-length relationship puts it in a strong position to allay concerns about excessive government involvement in medicine, she said.

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