To paraphrase Douglas MacArthur, “The patient, and the patient, and the patient.”
That’s my optimistic take-away from yesterday’s Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting.
But, you know what they say about best intentions.
The session began on a less than auspicious note with a PowerPoint presentation from the PCORI-retained public relations firm on how to best develop the institute’s “brand.” Suffice it to say there was a lot of multitasking going on. What’s next on this particular agenda? A PCORI theme song?
Then it was time to get down to serious business. And the first was the announcement of Joe Selby as PCORI’s first executive director. (He is a member of the Institute of Medicine, where he has studied quality and effectiveness issues. Selby joins Team PCORI from Kaiser Permanente in Northern California where he was director of the research division and oversaw a team of over 50 investigators and 500 research staff working on more than 250 ongoing studies.)
After PCORI Chairman Eugene Washington made the announcement, Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”
Good luck Joe. You’ll need it.
Various discussion items followed. Of particular interest was that of PCORI undertaking (led by the Program Development Committee) of a Landscape Review of comparative effectiveness research (CER) – and this generated much debate. Most important (and bear with me for a minute on this) was whether or not, once completed, this mega lit search should be posted on the PCORI web site. It was astutely pointed out that this should not be the case – as it would give a sort of implied official imprimatur to the listed studies. Surprisingly and positively there was general agreement that this survey should not appear online.
There was then a general discussion on what the “legacy” of PCORI would be. And while that might sound a little grandiose and, well, premature – it did focus the board on what unique research role the institute can play in advancing the public health from a patient-centric perspective.
No real answer. But a good question and the best comment came from NIH Director Francis Collins who said that if PCORI was looking for a unique and non-duplicative research agenda, it would be “a null set.”
Public comment followed. Mine consisted of the following points:
PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers. The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects. The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it. PCORI should take the lead. After all, what’s more patient-centered than real world outcomes data?
PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics. After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?
PCORI should help to advance the nascent science of adaptive clinical trials by creating and creating a home for www.adaptiveclinicaltrials.gov. After all, what’s more patient-centric than adaptive clinical trial information?
PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls. And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.
(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)
PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.
PCORI should beware of information sharing via academic detailing. (Note: 20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.
PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”
Next up was the report of the Methodology Committee and the centerpiece of this portion of the program was a working definition of “patient-centered outcomes research” (PCOR). (Note: the word of the day was “iterative.") Here is the committee’s first draft effort
“Patient-Centered Outcomes Research helps people make informed decisions and allows their voice to be heard in assessing the value of healthcare options. Given my personal characteristics, condition and preferences, what should I expect will happen to me? What are my options and what are the benefits and harms of those options? And what can I do to improve the outcomes that are most important to me?
Nice. These “four questions of PCOR” should be widely shared and discussed. If PCORI is looking ahead towards its “legacy,” this is a good place to start.
At the end of the meeting, one of the board members came up to me and said, “I don’t think you understand what PCORI is about.” She was confused that I had brought up the issue of cost controls in my remarks. “Don’t you know what we are, by statute, not allowed to take costs into consideration in our work?”
I told her that I understood very well – but that, well, you know what they say about good intentions.
