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Taylor Walsh Reports: Patient Centered Research Initiatives Reaches Out With First Funding Imminent PDF Print E-mail
Written by John Weeks   

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. 
Public Comment on PCORI's National Priorities is Open through March 15
The draft plan and web-based mechanism to provide feedback are located here.

Author Taylor Walsh
Washington, D.C.-based Taylor Walsh, an
Integrator adviser and frequent contributor, first wrote for the Integrator on comparative effectiveness research via a report on a November 2009 The Institute for Integrative Health symposium. That meeting explored the intersection between integrative medicine and comparative effectiveness research (CER). Many in the integrative health community view CER as a research focus that is potentially more hospitable to examining the social value of whole practice and whole systems integrative approaches.

This report follows Walsh's ongoing coverage of the topic, available here. He brings an exceptional set of skills, interests and opportunities to his reporting on Beltway integrative health-related topics. First,Walsh has a firm commitment to the advance of integrative medicine and health. He is particularly drawn to the associated research issues. Walsh also brings insight gained through consulting experience with such significant entities as The Institute for Integrative Health (TIIH) and the Samueli Institute. Walsh is also infected with the virus of policy intrigue that seems to be carried by the lower Potomac River. These he knits together via his fine chops as a writer. Enjoy this report, then click here to access the PCORI plan and contribute a response.  

PCORI Reaches Out With First Funding Imminent

Taylor Walsh
Consultant, Entrepreneur and Writer on Digital Media & Integrative Health
Washington, D.C.
Getting to Integrative Health & Wellness

Twitter: @taylorw

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
PCORI's site visits around the country included meetings with integrative practitioners (disciplines not enumerated) while in San Francisco.  A staff member who participated there said privately that she was surprised to learn that CAM practitioners she met were unaware of PCORI.)  Levine's report made it clear that integrative practitioners were not alone in that regard.   

In summarizing their reactions, she noted: "Many were concerned that corporate agendas rule.  They feel removed from research activity."  She said that while clinicians share the same patient-centering goals as PCORI, "they use different language" to express it.   They believed the agenda to be "too broad, too over-reaching, and too idealistic to have a meaningful impact.  They asked how can we ignore costs, access and payer decisions that overshadow clinical outcomes."

Ongoing communications with clinicians, Levine said "will be critical," noting that most preferred to learn of PCORI activities through their professional organizations.

Will the orientation described by Krumholz to do "research done differently "remain open to its initial concepts for broadening the paradigm?  Several strong recommendations reflected emerging new patient-centered realties.  Stuart Spielman of Autism Speaks advised,  "Use patient groups as intermediaries.  Science should look at patient groups as allies."   In the last couple of years, social media has been used to create new models based on this idea.  The Army of Women formed by the Susan Love Foundation and the patient community site have been forming and organizing patient communities to play more direct roles in research and data collection.  Models like these would fit one of PCORI's five primary proposed research priorities: "Accelerating Patient-Centered Methodological Research."

Andrew Sperling of the National Alliance on Mental Illness (NAMI), reflected a widely shared sentiment among other speakers by urging PCORI to focus on complex medical co-morbidities.  To use a phrase from another realm altogether, such research would fall directly into CAIM's "wheelhouse."

PCORI will be speeding through the next 90 days, re-crafting its national agenda, evaluating proposals and making its first funding awards.

"In order to be funded by us," Krumholz told the stakeholder meeting in Washington, "you need patients and clinicians on the team.  Maybe we need to make sure the patients have shaped the framing of the research question."  The selectors, he asserted, "will lean toward research questions that are compelling enough, teams that are strong enough."
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.

Comments: The frustrations with the seemingly unyielding reductionism inside the NIH - regardless of whether such reductionism best serves the public - makes PCORI the default best game in town for whole practice, whole person and whole systems approaches. Such language remains notably absent in the NIH NCCAM 2011-2015 Strategic Plan. So
make your voice heard by weighing in here until March 15. Here are some possible talking points from dialogues with colleagues on the plan:

  • 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. 

Thank you Taylor, for taking the time to write up this report on PCORI's plan and next steps. Now, Readers, please take a moment to help push open the door to research opportunity that many of us hope to find in PCORI.
Weigh in here.

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