Culture Change: Patient-Centered Outcomes at the Center of New $600-Million/Year Quasi-Governmental Research Institute (PCORI)

Summary: Consider the irony in establishing a research institute to prioritize patient-centered interests and outcomes. Shouldn’t this be the focus of all healthcare research? The Board of Governors of the new quasi-governmental Patient Centered Outcomes Research Institute (PCORI) are taking the patient-centered charge seriously. They view themselves as leaders of a significant culture change in research. The 4 questions they urge researchers to answer will resonate with those whose practices, and outcomes, are whole-person and integrative. In a recent Seattle meeting, the Board strategized about how to meet its considerable challenges. Not the least of which is the strangling of innovation by the pharma mind that dominates research. Among those presenting in Seattle was a panel on complementary and alternative medicine. CAM is a mandated PCORI interest. Daniel Cherkin calls the work a sign of “real hope” for US medicine. Carlo Calabrese calls PCORI “the most important work in health care research today.” Here is a look at PCORI’s recent Board of Governors meeting and a few of the directions urged by the CAM panel.


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Patient-Centered OutcomesResearch Institute

Why do we need to have a research institute dedicated to being
patient-centered? Shouldn’t all medical research be patient-centered?

One of the Governors of the powerful new Patient Centered Outcomes Research Institute
(PCORI) tossed these comments out during a break in a PCORI Board of Governors meeting and “listening
session” in Seattle on September 19, 2011.

The questions, half in jest, succinctly comment
on how far the U.S.’ $30-billion research apparatus upholding the awful population-wide outcomes of the US healthcare system has strayed from a patient-focused mission. How is it that the pay-dirt of outcomes patients identify as important is not even on the
horizon of so much research?

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Observers of the initial activity of PCORI witness an agency taking its transformational task seriously. PCORI is a quasi-independent, non-governmental agency created via the Obama Affordable Care Act. By 2014, PCORI is expected to dispense over $600-million a year in outcomes
research with a re-framed focus. This amount far
over-shadows what the National Institutes of Health presently parses out
for real-world research.

Step 1 for PCORI: Realize no definition of “patient centered
outcomes research” existed to guide their priority setting and grant-making. The concept wasn’t on the NIH’s radar. The Governors created a Methodology Committee and it went to work. Below is
the draft definition of Patient Centered Outcome Research,
made public in July, together with the 4 associated questions to conceptually guide researchers. Those who view their practices, and outcomes, as patient-centered will likely be intrigued.

_____________________________

PCORI’s Draft Definition of “Patient-Centered Outcomes Research”

“Patient-Centered Outcomes Research (PCOR)
helps people make informed health care decisions and allows their voice
to be heard in assessing the value of health care options. This research
answers patient-focused questions:

1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”

2. “What are my options and what are the benefits and harms of those options?”
3. “What can I do to improve the outcomes that are most important to me?”
4. “How can the health care system improve my chances of achieving the outcomes I prefer?”

_____________________________


In their rationale for the definition,
PCORI’s Governors steadily train their eyes on the prize. The next step in shaping
the PCOR definition is to take the draft, which has
already had a public comment period, to a series of patient focus
groups. In addition, the PCORI board is contracting with an outside
entity to access best practices, in any industry, for bringing consumers
into major decision processes. Patient input will help set priorities and develop research questions. 

Confronting the restrictive biases of reviewers


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Epstein: Need to retrain the reviewers

Challenges to
significant culture change were never far from the discussion. Since PCORI wants “to transform the way research changes
lives,” how are they to establish this new research platform?

A significant discussion emerged on managing the evaluation of research proposals. “How are we going to get this (patient-centeredness) into the review process?” asked Arnold Epstein, MD, the John H. Foster Professor and
Chair of the Department of Health Policy and Management at Harvard
University School of Public Health in Boston
. “We’ll have some 600 reviewers. How do we get them to see how we apply patient-centered outcomes?”

   
  “If we create a standard for all of our
research and it becomes the standard for

others, we can change the culture.”

Eugene Washington, MD, MSc
PCORI Chair

   

The governors explored how they might ensure that exceptional, innovative, patient-centered projects are not shot down by researchers rutted by reductive models.

One governor suggested a training for reviewers. Another offered
creating a kind of crib sheet check list to keep reviewers focused on
the new ideas. PCORI chair Eugene Washington, MD, MSc, the dean of the David Geffen School
of Medicine at UCLA,
capped the dialogue: “We need to create a
patient-centered outcomes research filter, a PCOR lens, to make sure
(the work of the reviewers) aligns” with PCORI’s new approach.

The theme did not go away. The mindsets of reviewers and of typical researchers
are clearly an obstacle to fulfillment of PCORI’s mission. How
can innovative ideas gain acceptance? Another suggestion: Specialized
workshops to train existing health services researchers. Maybe also
workshops to train those “who are not previously researchers, for more
of a blank slate,” Epstein added.

Washington, again, summed up: “If we create a standard for all of our
research and it becomes the standard for others, we can change the
culture.”

Perspective of two CAM health services researchers


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Dan Cherkin, PhD, a leading health services researcher in complementary
and integrative medicine, attended the first day of the meeting. Cherkin, with the Group Health Research
Institute
, is on the
National Advisory Council for Complementary and Alternative Medicine
(NACCAM). In a note to colleagues and to PCORI board member Leah Hole-Curry, JD the next day Cherkin
wrote (and subsequently approved for sharing):

“As I was watching the proceedings yesterday afternoon, I
was repeatedly struck by the intelligence, thoughtfulness, respectfulness,
sensitivity, collaborative spirit, dedication, and engagement of the Board
members in their work. You have all agreed
to take on a monumental task with no blueprints for building the remarkable organization
you are in the process of creating. Although the surreal circumstances of the health care reform legislation
that gave birth to PCORI were inauspicious, with excellent leadership and
impressive Board members, you are creating something quite remarkable that has
the potential to have an enormous impact on diminishing patient suffering. Your work gives me real hope that, despite
all the forces working against improving health care in our country, real
progress is on the horizon.”

   
   
“(PCORI’s) work gives me real hope that,
despite
all the forces working against improving
health care in our country, real
progress

is on the horizon.”

Dan Cherkin, PhD

Cherkin was part of a 5-person group of
clinicians and researchers who presented in an evening panel  for the
PCORI board on CAM research in the Pacific Northwest.

Patient-centered outcomes research is not synonymous with CER


Notably, PCORI decided early to drive a wedge between it and “comparative effectiveness research” (CER). The “Guiding Principles” in their definition process included this important distinction:

“The group felt that from a
patient’s perspective, adopting a definition of PCOR that was
synonymous with CER would not sufficiently describe the aspiration of
this form of investigation. PCOR aspires to give voice to the patient
while helping patients improve their experience and decision making in
the healthcare system. Not all research that might be expected to help a
patient make decisions or improve their experience in the healthcare
system is explicitly comparative, and comparative evaluations do not
necessarily incorporate the patient’s voice, outcomes that matter to
patients or comparisons that they value.”

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The Board of Governors is on a tight
time-frame. The group is staging a series of white papers, investigations and
fact-finding processes for a May 2012 major report from the PCORI
Methodology Committee. Those interested can go to PCORI’s Public Input page and can sign up for the list-serve.

Carlo Calabrese, ND, MPH,
executive director of the

Naturopathic Physicians Research Institute, also attended the meeting and
participated in the CAM panel. The former
NACCAM member is a leader in his profession’s push for outcomes research
and particularly that which looks at the experience that the patient
has when encountering providers who take a whole person, health-oriented
approach: This is hands down the most important work going on in US healthcare research today. Right here. In this
room.” 

__________________________________________


Notes on the CAM Presentation in the PCORI Board “Listening Session”


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Mootz: Organized CAM group

Through Calabrese and Michelle Simon, PhD, ND, a member of the Washington Technology Assessment Program Clinical Committee,
I was invited to participate with Cherkin in the 5 person panel. Washington State Department of Labor and Industries associate medical director Robert Mootz, DC rounded out the group. Mootz was the principal organizer of the panel. The group was aware that the September 19, 2011 panel was probably the one focused
listening the Governors would have on complementary and alternative medicine (CAM) as they toured other regions. Here are key points:

  • Simon and Calabrese in particular stress the mind-body-spirit, whole person, health-focused nature of the CAM practices. They introduced the concept of anticipated positive side-effects from whole person approaches through both description of practice and through examples of whole person research.
  • Positive indirect outcomes from whole person care that have been found and reported as “unanticipated” are actually expected by health-focused integrative practitioners working with patients who have chronic conditions.
  • The CAM movement is/was patient-centered. Urged them to consider the expertise in the movement relative to individualized, patient-centered approaches.
  • Cherkin and Mootz each underscored how good health services research projects have
    shown effectiveness for CAM for significant chronic conditions. They argued that more
    patient-centered research on CAM use for other conditions is warranted.
  • Most urged the Governors to take the the lead of the patient and examine the value of the whole practice, of the discipline, instead of looking at pieces of CAM.
  • We pointed out that, at this point in time, if CAM/integrative practices are not explicitly and directly included in documents, in committees and at the table, that the rich CAM perspectives and depth experiences in patient-centered, comparative environments are likely to be forgotten.

  • I urged the Governors to take seriously the potential leadership from CAM and patient-centered integrative practitioners by appointing
    CAM researchers to committees and task forces and hiring or
    retaining one to continually offer a CAM/integrative perspective.


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Simon: Clinician described positive side-effects of wholeperson practices

The next day, Mootz passed the following note on to the CAM presenter team. He approved it for sharing:


” … feedback received so far was that it was useful. The chair
especially appreciated our organization and plowing through all the information
while only going 12 minutes over. Several observers who were there mentioned to
me this morning that they were quite impressed with the degree of CAM
accomplishments and how well our presentation truly aligned with what PCORI is
supposed to be all about. Patient-centeredness and how the whole context of
intervention needs to stay on the radar screen. That 50% of NCCAM funding [to cam schools] went to PNW
institutions stuck, as well as the degree of explicit integration (any willing
provider, collaborative research, etc).”

If anyone would like to see the group’s presentation slides, please send me a note. Again, to track PCORI developments, go to PCORI’s Public Input page to sign up for the list-serve

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