Invited Commentary: Calabrese on the Opportunity for CAM in Comparative Effectiveness Research
Written by John Weeks
Invited Commentary: Carlo Calabrese, ND, MPH on the Opportunity for CAM and Wellness in Comparative Effectiveness Research
Summary: This invited column from whole practice researcher Carlo Calabrese, ND, MPH, offers exceptional insight into the extent to which opportunity exists for advancing our understanding of integrative practices through the current movement for "comparative effectiveness research" (CER). Calabrese, who currently holds positions with the Helfgott Research Institute and Oregon Health & Sciences University, has focused on practical, real-world outcomes since before he began his MPH work in the early 1990s. His conclusion is both sobering and enlightening as to the steps the CER movement must take to begin to allow the kinds of comparisons wellness, patient-centered care and integrative practice need. The case clearly made in this column should be put in front of President Obama's Federal Research Council on CER.
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Carlo Calabrese, ND, MPH - advocating a patient-centered, wellness agenda for CER
What participant in the integrative practice arena has not heard the claim made that, given the appropriately designed trial, wellness-oriented integrative interventions would be more effective and cost effective than the drug or procedure that is the typical conventional alternative? What participant has not uttered such thoughts themselves? (Why else are we here?) The claim, in this sometimes highly antagonistic environment, is comparative. It's a challenge to a duel.
While such boastful challenges have been made countless times over the past 3 decades, we have yet little evidence, one way or the other, as to their veracity.
For this reason, the practical movement toward "comparative effectiveness research" (CER), elevated profoundly by the $1.1-billion for CER in Obama's stimulus package, has significant attractions. Finally, it seems, we have potential funding to have two distinct approaches walk 10 steps, turn, and fire. As reported here in the Integrator, complementary and alternative medicine (CAM) has in fact garnered mention in reports on CER from both President Obama's Federal Coordinating Council for CER and from the Institute of Medicine.
Calabrese's
perspective is clarifying, insightful and sobering.
It is also one
which should be placed in front of Obama's Federal Coordinating Council for CER.
The Integrator requested commentary on the CER opportunity from Carlo Calabrese, ND, MPH. Calabrese is a researcher whose interests have been distinguished by a focus on real world outcomes from prior to his MPH study in the early 1990s, through a stint as founder and co-director of the Bastyr University Research Institute, a term on the advisory board of the NIH National Center for Complementary and Alternative Medicine, and currently, in his roles as a senior investigator at the Portland, Oregon-based Helfgott Research Institute and a
faculty appointment in the Dept of Neurology at Oregon Health & Sciences University. He also serves on the Research Working Group of the Academic Consortium for Complementary and Alternative Health Care. Among his current projects is fostering outcomes research in the naturopathic medical profession through examining electronic medical records.
Calabrese's perspective is clarifying, insightful and sobering. It is also one which should be placed in front of the Federal Coordinating Council for Comparative Effectiveness Research.
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Clarifying the Opportunity for CAM and Wellness-Oriented Approaches in Current Comparative Effectiveness Research
The
CER movement advocates comparing two treatments, proven to produce medical
benefit for a disease, to determine which is better. The time for the CER
has come due to the creativity of the pharmaceutical industry in competitively
developing redundant and not very different solutions to common problems.
This is very good and long overdue for drug
comparisons but won’t reveal the value of most natural medicine interventions
because the method is only valid for comparing treatments that look, from the
patient’s perspective, like each other—two pills, two surgeries, two
radiological procedures.
CER as currently understood by its establishment
advocates won’t really tell us much about the medical game-changers of
lifestyle medicine.
In “efficacy” research, investigators are usually interested in
whether a treatment has a biological effect, on a population basis, in people
who receive the treatment (or, if an intention-to-treat analysis is being done,
those who are assigned to the treatment). In “effectiveness” research, as
opposed to efficacy, we are interested more in the real world effect of a
treatment. Effectiveness is influenced by, for example, whether patients
will adhere to treatment. Adherence is affected by many
things--expectation, cultural fit, motivation, length of treatment, the
readiness of the patient and provider performance.
The more complicated the
intervention, the more variable adherence will be. Obesity studies, for
example have high variance in outcome, because treatment involves education and
counseling, lifestyle analysis, diet, exercise, self-monitoring and perhaps
medication. In other word CER as currently understood by its establishment
advocates, won’t really tell us much about the medical game-changers of
lifestyle medicine because of the adherence problem.
In
the article “Rethinking Randomized Clinical Trials
for Comparative Effectiveness Research: The Need for Transformational Change,”
Luce et al. recommend several methods expansions for CER. They suggest
Bayesian and adaptive design techniques to improve efficiency of studies,
making comparisons reveal their results with fewer patients. They
recommend “pragmatic” trial design, by which they mean to accept all volunteers
to a trial with the medical indications which are likely to be those used in
practice, rather than focusing on subjects in whom the treatment is most likely
to work.
The as yet unconsidered: study of treatments that look different to the
patient
Most of wellness-oriented
medicine and most CAM—won’t
be on
addressed in comparison
to more conventional medical
treatment under CER.
What they have not considered are solutions for CER in the study of treatments that look different to the
patient: lifestyle and mind-body vs drugs, different types of providers,
or even different volumes or organoleptic qualities in oral treatments.
Many of the treatments that are potential game-changers in medical
effectiveness--most of wellness-oriented medicine and most CAM—won’t be on
addressed in comparison to more conventional medical treatment under CER.
Studying these treatments in comparison to magic-bullet medicine will require
the frank inclusion of the patient’s choice as a study entry criterion. The effectiveness of health services that patients choose to
use should be of great interest to health policy makers, to practice regulators
and to third party payers (not to speak of to patients themselves), even though
the treatment complexities may make them of less interest to pharmacologists.
The CER movement should
become more patient-centered
and not exclusively
responsive
to questions of interest to those
who find the only solutions to
our
healthcare crisis
in drug variations.
The dogma of random assignment itself should be reconsidered in at
least some corner of the CER movement. As currently pursued, CER
should stand for ”comparative efficacy research” As such it is an
excellent research counterpart to the typical 6 minute visit to the
conventional doctor’s office, answering the question “What drug works better?”
rather than something closer to “What is best for the patient?”
The CER movement should become more patient-centered and not exclusively
responsive to questions of interest to those who find the only solutions to our
healthcare crisis in drug variations.
