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PCORI Nails Down a Definition, at Last

 |  By cclark@healthleadersmedia.com  
   March 08, 2012

It's taken more than a year, about 60 hours of face-to-face time, and countless hours on e-mail, for each of the 15 high-powered members on the working group of the Patient-Centered Outcomes Research Institute.

There have been drafts, and re-writes and countless iterations. Two university focus groups took it apart, it was revised, and then it went out for public comment. The 600 responses each were analyzed and categorized, resulting in more changes, more editing.

"We spent a ton of time to get this right," David Flum, MD, a surgeon at the University of Washington Medical Center who led the committee's effort, tells me. "All different perspectives were engaged."

As of Monday, finally, the big long project is finished: PCORI's Board of Governors met in Baltimore and voted approval of its first definition of "patient-centered outcomes research," until now a patchwork of phrases and concepts.

And it's only 210 words long.

A Hard-to-Come-By Definition
Getting to a definition wasn't easy.  It had to encompass "comparative effectiveness research," the typical scientific research projects that evaluate and compare the worth and quality of various treatments that providers now administer to patients.

But it also had to capture separate concepts that include the process of patient-healthcare system interaction: how patients and providers communicate, studies of barriers, such as transportation or language, to optimal care, how patients can get the best information about options, as well as what patients should do to improve those outcomes themselves.

A few members of PCORI's governors don't like the finished product and quibbled for 30 minutes before voting. Two of the 20 members who attended voted against and one abstained. There was passion, or maybe it was angst, in the room.

Convoluted? Skewed Toward Research?
Board of Governors member Francis Collins, MD, head of the National Institutes of Health, questioned whether the new definition is "skewed" to emphasize research in how patients and their caregivers communicate instead of research in what kind of care and treatments produce the best patient outcomes.

Arnold Epstein, MD, Chair of the Department of Health Policy and Management at Harvard University School of Public Health, said he didn't think the final definition put enough focus on research in methods of care delivery. For example, whether nurse extenders can play a larger role in patient care, or ways patients can keep better track of their medications.

And Ellen Sigal, founder of the research think tank Friends of Cancer Research, called it  "convoluted" and "complicated."

But in the end, most said it was something they could live with, at least until the board decides to rewrite it again. Or maybe they were just worn out and wanted to go home.

"We just need to come up with a decision and move this forward, or face embarrassment after all these months of trying to make a decision," Collins said, adding that he was "loathe" to make any negative comment in the first place, after all the work that had gone into it.

"As someone who has been involved from the very beginning, I do want to say that this has been extraordinarily difficult," said Harlan Krumholz, MD, Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation.

"Bravo," said Carolyn Clancy, MD, director of the Agency for Healthcare Research and Quality. "The scheduling challenges alone for this rather large group are close to giving me a headache." 

Patient Sentiment Essential
During our interview, Flum explained that it was critically important to reflect patient sentiment in any definition of patient-centered outcome research. A lot of feedback the committee received from patients "highlighted the fact that when people hear about research, one of their major complaints is that it fails to engage them in a conversation, and fails to use language they understand. It doesn't allow their voice to be heard." 

"It's essential that the research we do helps people make improved decisions," he says.

That sounds like research proposals to examine how researchers and providers can be better communicators about their findings might get some money.

The desire to expand the definition of patient-centered research reminded me of the need, highlighted in a study this week from the Dartmouth Institute and the Informed Medical Decisions Foundation, to get a better handle on what patients are told about their procedures before they undergo them.

For example, researchers found recently that many Medicare patients who underwent certain procedures said their physicians gave them no advance information about more conservative options with similar survival outcomes.

That study, however, was flawed by the fact the patients answered the survey on average 14 months after they were discharged and may have forgotten what they were told.  Other projects should ask such questions much sooner, perhaps tagged to post discharge surveys required by Medicare.

That's "absolutely" the idea the definition is trying to get at, Flum tells me. "One of the components we're considering right now is the timeliness issue...and for how long patient-reported outcomes are tracked and whether there's an appropriate window."

Did this painstakingly crafted definition take a lot of time? Obviously. Did it take too much time? Probably, but I wasn't there to appreciate the difficulty in managing large numbers of healthcare providers with busy schedules and divergent interests.

It's safe to say that this is an organization that has to be as scientific and careful as it has to be politically savvy and listen to all voices, especially now when Republican presidential candidates are vowing to tear into the Affordable Care Act. It's clear that PCORI, with its substantial coffers, doesn't want to give them ammunition.

In January, the organization issued its first report, required by the Affordable Care Act that created it, spelling out areas of priority for research.  That report, now out for public comment, fell far short of that.

Instead of listing what research projects the agency would prioritize, the 22-page report listed only five general topics. With so few specifics, it seemed the report wouldn't offend anyone.

PCORI's 21-member Board of Governors, appointed by the Government Accountability Office in September 2010 has met nine times so far, while its working groups and committees have met a lot more.

The board has has spent $8.8 million of the $3.5 billion to date, and has a staff of 14, with another 41 expected to come on board by year end. And in a few months, it will move to much bigger office space down the street from the White House.

In the end, it is clear that examining the process of getting patients together with appropriate care decisions that give them the outcomes they want, not what their doctors want, is what this committee intends to do.

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