Taylor Walsh Reports: Patient Centered Outcomes Research Institute Reaches Out With First Funding Imminent

Summary: A draft plan is on the books for a major research initiative that many in the integrative practice community believe is potentially more aligned with whole system integrative approaches. The initiative is the Patient Centered Outcomes Research Institute (PCORI). Integrator adviser Taylor Walsh, an integrative medicine policy wonk, has been tracking this movement since it broke as "comparative effectiveness research." Walsh filed this excellently written report after PCORI's day-long hearing on its draft plan and a PCORI Board of  Governors meeting on which he listed in. I conclude with some possible talking point for your response to the plan as gained through dialogue with colleagues. Click in  here and be heard. 

Author Taylor Walsh

Washington, D.C.-based Taylor Walsh, an

PCORI Reaches Out With First Funding Imminent

In late February in Washington, the Patient Centered Outcomes Research Institute (PCORI) convened The National Public and Stakeholder Dialogue for Patient Centered Outcome Research to hear initial reactions from patients and stakeholders to its proposed national priorities and research agenda. Judging by the passion of board member Harlan Krumholz, MD, the PCORI is setting out into a research program that is not your father's GP's agenda.

Patient-Centered Outcomes Research Institute: Draft Plan offered

A crowd approaching 400 gathered in the main ballroom at the National Press Club; 450 more attended by webcast. Two panels of speakers - for "Patients and Caregivers" and "Clinicians and Stakeholders" - were followed by an afternoon session of public comment from 46 organizations and several individuals. 

Krumholz, a cardiologist and professor of medicine and epidemiology at Yale's School of Medicine began his remarks by saying that among PCORI's primary objectives is "To be transformational.  Not just about funding, but as a movement that put patents firmly in the center."   Patient involvement, he said, "is our true north."

"We have a chance to take some risks now with PCORI resources," he said. "What can we do that might fundamentally shift the rules? We want to be patient advocates, to ensure that we promote the best interest of patients. The way we've been looking at things doesn't have to be the way we continue to do so."

"Maybe we can invert the traditional power structure just a bit, so that people are ensured that the final decisions are in alignment with patient values and goals."

PCORI's first act of inversion is evident in its proposed national priorities for patient-centered comparative clinical effectiveness research that were adopted only at the end of January.

• Assessment of Prevention, Diagnosis and Treatment Options: Goal to determine which options work best for distinct populations with specific health problems.
• Improving Health Care Systems: Focuses on way to improve healthcare services, such as the coordination of care for patients with multiple chronic conditions. 
• Communication and Dissemination: Looks to ways to provide information to patients so that they, in turn, can make informed healthcare decisions with clinicians
• Addressing Disparities: Assures that research addresses the healthcare needs of all patient populations.  This is needed as treatments many not work equally well for everyone,
• Accelerating Patient Centered and Methodological Research: Includes patients and caregivers in the design of research that is quick, safe and efficient.

These mostly general goals have caused discomfort among the many organizations that have traditionally driven medical research. As Krumholz put it:  "We didn't want to choose, and say people with one condition are more important than others.  This is going to be research done differently.  In order to be funded by us you need patients and clinicians on the team."

Harlan Krumholz, MD

The panelists from the participating stakeholder associations included several charter members of the yet-to-be-inverted power structure and they did not appear to welcome the prospect of inversion.  Several expressed serious skepticism about the idea that non-specific approaches to health research would yield any appreciable benefit. A speaker from the BIO organization said plainly, "We are critical of the PCORI approach.  The lack of specificity is a problem, making funding choices hard to evaluate."  

But if you go back to the formative documents with which the Institute of Medicine set out a proposed new regime for Comparative Effectiveness Research and for establishing a PCORI, the underlying change factor was the belief that medical research had to become more open and provide more quickly usable information for decision makers, physicians and patients.  (It is worth noting that a member of PCORI's Research Prioritization Working Group is John Ionnidis, MD, PhD, now at Stanford.  His meta-research into the processes and results of medical research in the 1990s pulled the curtain back on the then dysfunctional processes that the CER initiative was created in part to address. For an eye-opening account of Ionnidis' views on research, check his Lies, Damned Lies and Medical Science, in the November 2010 Atlantic.)

This skepticism of a non-specific orientation continued a week later during the public comment period when full PCORI board met in Baltimore. The board (including Francis Collins, MD, PhD, Director of NIH) met to discuss the rapidly looming first funding announcements scheduled for mid-May, the process of folding in public reactions to its national priorities and research agenda, and how to broaden public awareness of its work.  

Sharon Levine, head of the PCORI's Communications, Outreach and Engagement Committee summarized the comments from the previous week's national dialogue and the feedback obtained during PCORI staff visits to cities around the country in the weeks previous. (But not before she showed the board video excerpts of Harlan Krumholz's call to arms from the National Dialog meeting. The full video plus complete presentation slides for the day are here at the PCORI web site.)

Some cities and foci of PCORI public meetings

Walsh's notes on next steps: Public Comment on the National Priorities is Open through March 15, 2012. The draft version and space to provide feedback is located here. The webcast and meeting materials from the full PCORI board meeting of March 5 is available here.The board will present the adopted national priorities and its agenda at a public meeting on April 15.  This summer it plans to issue another set of funding announcements.

• Press on the importance of examining difference "systems of care" rather than merely different "health system" approaches.
• Urge examination of the phenomenon of the complementary and alternative medicine/holistic medicine movement - a largely consumer dirven and patient-centered movement - as a means of understanding "patient-centered" interests.
• Explore why and to what effect CAM/IM patient substitute CAM therapies and practitioners for pharmaceutical drugs and other conventional recommendations.
  
• Include elevated examination of comparative strategies for enhancing self-care and patient self-efficacy - and the extent to which any intervention improve or diminishes such patient empowerment.
• When they speak of the  need for more longitudinal comparative examination of care across systems, make sure that CAM use is included.
  
• Explain and note the value of whole person approaches in resolving co-morbid conditions.
• Urge PCORI to not limit comparativeness studies to those that have demonstrated prior effectiveness as this will limit exploration of the whole system approaches that other funders have not prioritized (and therefore have limited evidence).
• Urge language that explicitly states PCORI's plans to explore complementary and alternative health/integrative medicine approaches. The current plan does not. For instances, in two places lists of "non-physician" practitioners are offers and CAM/IM practitioners are not included.