Taylor Walsh Reports: Patient Centered Research Initiatives Reaches Out With First Funding Imminent
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.
Washington, D.C.-based Taylor Walsh, an Integrator
adviser and frequent contributor, first wrote for theIntegrator 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.
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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 PatientsLikeMe.com 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.
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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.