How many people each year suffer some type of preventable harm that contributes to their death after a hospital visit?
| ||Columnist Taylor Walsh Reports on Comparative Effectiveness Research (CER) in Oncology Summit||
Summary: The advancing comparative effectiveness research (CER) agenda of the Obama era has been linked to complementary and alternative medicine (CAM) since the IOM weighed in on the topic in June 2009. The health reform law specifically included integrative practices and practitioners in CER planning and an integrative care researcher was appointed to panel leading what will be a multi-billion dollar national initiative. Most recently, the NIH NCCAM cites CER interest as a prime mover toward "real world research." The Integrator has followed the evolving story, in part through the fine reporting Beltway-based reporter Taylor Walsh. Here is Walsh's report on the "National Leadership Summit on CER Priorities, Methods and Policy: Transforming Oncology through Comparative Effectiveness Research." Walsh reports the patient-involved strategies for CER. He also reflects on CER's origins, and the recent work from Stanford's John Iioannidis, MD, DSc that suggests flaws in 90% of the research medical research informing medical education and clinical opinion. (Unfortunately, the integrative practice community did not seem to be present at this summit.)
Articles in this series:
The June 2009 Institute of Medicine Report to guide federal expenditures on Comparative Effectiveness Research (CER) elevated "complementary and alternative medicine" as a subject for which a CER approach would be useful. IOM's inclusion of CAM would seem to create a venue for addressing assertions of countless integrative practitioners that it's a damn shame that more of what they do is not covered as their experience is that health care would be more effective (and cost effective) compared to conventional treatment.
Columnist Taylor Walsh
The Integrator has since followed CER developments, including NIH National Center for Complementary and Alternative Medicine (NCCAM) director Josephine Briggs, MD taking a lead role on an NIH-wide CER committee, the appointment of Christine Goertz, DC, PhD to the Board of Governors of the huge new multi-year CER-focused Patient Centered Outcomes Research Institute, and the elevation of "real world research" inside of NCCAM's 2011-2015 strategic plan.
Integrator columnist Taylor Walsh, a consultant and writer on integrative health and digital
media in Washington, DC, most recently covered CER at a meeting hosted by the Institute for Integrative Health (TIIH) that brought together leading integrative practice researchers with leaders in the CER field. The co-leader of the TIIH gathering, Sean Tunis, MD, was also convenor for this "National Leadership Summit on CER Priorities, Methods and Policy: Transforming
Oncology through Comparative Effectiveness Research,
Outcomes Research and Oncology Transformation
"National Leadership Summit on CER Priorities, Methods and Policy: Transforming
Oncology through Comparative Effectiveness Research," held Nov 1-2, 2010 in
Baltimore was a high-level gathering of several stakeholder communities with
strong interests in the work of the Patient Centered Outcomes Research
Institute, PCORI, established by the CER legislation earlier this year.
PCORI council was formally organized and its members appointed in September and
is now in the process of establishing its committees, notably on CER
methodology. The convener of the
summit, Sean Tunis of the Center for Medical Technology Policy (CMPT), said that the purpose of the working conference was to
"help PCORI create a CER framework for oncology." Tunis and conference keynoter, former CMS
director Mark McClellan, noted that cancer provides a good foundation as a
model for examining the many questions that the CER program is intended to
address, in particular for patient involvement in the process.
Tunis: Convened the exploration
has convened a number of CER and PCORI-focused workshops and meetings in the
last 18 months, including co-hosting the "Complementary and Integrative
Medicine Stakeholder Symposium" with the Institute for Integrative Health in
November of 2009, which was a first occasion for integrative researchers to
work with CER experts.
"The preferred approach is to
design studies that look like the real world
that don't look
like NCI-sponsored RCTs."
he has done introducing other meetings, Tunis reiterated the over-riding
purpose of the CER initiative itself, to address the inconsistencies that
plague medical research. "The gaps in
evidence," Tunis said, "reflect insufficient information for decision
makers." Later, responding to a
question, he boiled down the preferred approach that is evolving from such CER
discussions to "design studies that look like the real world...that don't look
like NCI-sponsored RCTs."
added, "There are many unanswered questions related to lifestyle, screenings,
targeted treatment - where we can identify those who are most likely to
respond, and delivery."
patient-centric approaches," he said, will enable researchers to "do work that
is relevant to funders."
the full conference included examinations of genomics, clinical evidence and
the value and costs of oncology research, this report primarily covers the
session entitled "Engaging Patients in CER."
This is perhaps the most problematic point of focus for CER, since
patients reside in that "real world."
Much of the CER initiative's establishing language encourages inclusion
in the evidence base what happens during the clinical encounter. which explicitly
includes the need to address the every day reality of CAM and integrative
approaches throughout the population.
As a practical matter for integrative
and research, PCORI creates an intersection
with the research agenda
now being prepared
by NCCAM as part of its strategic plan.
potential for patient engagement in CER was presented by speakers from the
nation's most prominent breast cancer advocacy and research organizations: The
Susan Love Foundation; Susan B. Komen for the Cure; National Breast Cancer
Coalition; the Research Advocacy Network (Otis Brawley, MD, chief medical
officer of the America Cancer Society, delivered a keynote).
Love, MD, MBA immediately expressed what many people believe. "The public is
not invested in CER," she said. Susan
Brown, MS, RN of Komen concurred: "We have not heard patients talk about
CER." The corollary to this is the
belief that patients and the public have a great deal to contribute.
Bonhoff, MBA, of NBCC, noted that, "Consumers have a voice that has a powerful
effect, (which is) acknowledged as insightful by specialists." Deborah Collyar, president of Patient
Advocates in Research said, "Patients are a rich source that is hardly ever
had the most to offer on an active role of the public, which she said, "is
ready and willing to participate." But
"they don't create studies, they depend on the medical establishment to recruit
and collect data." As Love described it,
this dependency is the flip side of the same problem: a flawed recruitment
process that too often produces flawed research. The providers and payers (and the electronic
medical records and health claims data that are the heart of the patient
record) she said, "are not set up for this purpose." In fact, they're in the way. Her strongly delivered recommendation:
"Dis-intermediate the medical establishment entirely."
On patient-centered research,
Susan Love, MD, MBA:
"Dis-intermediate the medical
organization is already well down this path.
In partnership with the Avon Foundation, it has created The Army of
Women, formed in 2008 as a matching service for
researchers. Prospective participants
self-select by registering independently on the website (and are then screened
and organized by the staff) thus forming an available trial participant
resource for researchers. The site has
more than 345,000 registrants (growing at some 4,000 a month). Forty trials have been initiated, with 17
completed. Of consequence to researchers
studying other real world conditions, the model has drawn the interest of other
chronic disease communities, including those that already have a significant
paradigm of "social research," according to Love, is based on bringing the
public in at the beginning. It is worth
noting that 80% of her registered members are not patients or survivors. This is as good a model as any for PCORI to
mull over, since it is built on the place patients and their advocates can
mostly be found and the continuing hand off of health responsibility to
paradigm of "social research,"
according to Love, is based on bringing
public in at the beginning.
dramatic recommendations and observations from the advocacy community included
these from Bonhoff of NBCC:
confusion and emotional upset that arises from conflicting results, such as the
mammogram guidance reported earlier this year.
pressure to employ very expensive technologies, such as fMRIs
("Few trials look at reduction," she noted.)
also warned about perceptions, as CER starts to receive more public
attention. Bonhoff said it could be
perceived as limiting choice. Collyer
said, "My biggest concern is that the ‘C' will stand for cost."
steps in PCORI/CER process
now with the Brookings Institution, said that several cost-based reforms will
be tried in the next two years under the CER program, and noted the formation
of an independent payment advisory board that wants to reduce research spending
per person by 3 -4%. "We need a stronger
foundation for what works," he said, emphasizing the need to strengthen the
"infrastructure for care improvement." Including:
infrastructure: with consistent patient information collection and exchange,
registries and decision support tools
measurement: collecting and aggregating outcomes and costs data
strategy and support: to build randomization structure into trials that will
help evaluation of policy benefits, and show how specific sub-groups are being
Prospects for CER?
Iioannidis: 90% of usual studies problematic
this conference was held the week before Election Day, Tunis felt compelled to
speak to the looming political question that now hangs over CER and the entire
new health law. "The problems and
principles of approaching research are firmly embedded," he said. "They will persist whether or not PCORI
exists (as a distinct program). We've
gone past the tipping point."
creation of the CER program was a reflection of an awareness of problems in
medical research first observed in the 1990s.
For an eye-opening report of how far past the tipping point the CER
train has gone, see the November 2010 issue of Atlantic Monthly, which describes the work of John Iioannidis, MD,
DSc (as of September 2010, the head of the Stanford Prevention Research
Center), whose now much embraced studies on the process of medical research
itself concluded in 2005 that "as much as 90% of the published medical
information that doctors rely on is flawed."
Well known in the research community since its release, these disturbing
findings will now reach coffee tables and web screens in the real world, on
paper and here at Atlantic's web site. (Stanford
release on Ioannidis appointment is here.)
creation of the CER program
was a reflection of an awareness of
first observed in the 1990s.
Comment: Walsh independently shared with me that it didn't appear that anyone that he knew to be linked to the integrative practice community was at the meeting; and no one else made a point of announcing their research interests as connected to these fields. Hopefully we will see researchers begin to show up if NCCAM significantly elevates "real world outcomes" and CER in its portfolio and more dollars are dangled to attract researchers. The quickest way to give more patients access to integrative care in our busted system is to show proof of comparative effectiveness (and, if you can slip it past the censors) cost-effectiveness. Deborah Collyer's "concern that 'C' will stand for cost" in our broke system amounts, roughly, to concern that we will actually notice the elephant in the room.
|Resumes are useful in employment decisions. I provide this background so that you may understand what informs the work which you may employ in your own. I have been involved as an organizer-writer in the emerging fields......more||
Popular & Related Products
Popular & Featured Events
Error Reading Event Calendar
Stevia Products & Info
Dimensions of Wellness