PCORI board votes on research definition
The Patient Centered Outcomes Research Institute (PCORI) board voted 17-2, with one abstention, to adopt a definition of patient-centered outcomes research that begins with a broad summary followed by a list of characteristics. According to the definition, such research "helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options." The research evaluates preventive, diagnostic, therapeutic, palliative or health delivery system interventions; focuses on outcomes such as survival, function, symptoms and quality of life; incorporates a variety of settings and diversity of participants; and "investigates optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives."
The definition does not mention "comparative effectiveness research." PCORI's methodology committee, which drafted the definition, said the research includes many components of comparative effectiveness but is intended to be "broader."
Several board members voiced concerns about the definition's focus on communication and decision-making. NIH Director Francis Collins said the definition does not emphasize research, which he called the "primary function" of patient-centered outcomes research. However, the members also expressed a desire to adopt the definition to allow PCORI to focus on other goals such as developing research priorities and launching an annual research conference. Created by the Patient Protection and Affordable Care Act, PCORI expects to have about $112 million in funding for 2012, of which $90 million will be used for grants.
Dr. Collins’ concern isn’t new. At past meetings, when the discussion of what PCORI’s “legacy should be, the NIH Director said that if the Institute was looking for a unique and non-duplicative research agenda, it would be “a null set.”
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. 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.”
In May 2011, PCORI Chairman Eugene Washington introduced Joe Selby as the institute’s first executive director. To which Dr. Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”
Joe – It might be time for those night vision goggles.