Pure Blog: NCCAM to Examine "the Effectiveness and Cost-effectiveness of CAM in Community Settings"
Written by John Weeks
Pure Blog: NCCAM to Examine "the Effectiveness and Cost-Effectiveness of CAM as Practiced in Community Settings"
Summary: Time for
congratulations. On September 5, 2007, the National Advisory Council to the NIH National Center for Complementary and
Alternative Medicine (NCCAM) affirmed a concept paper for a
new program. Finally, NCCAM will support "those studies examining the
effectiveness and cost-effectiveness of CAM as practiced in community
settings." Here is the concept paper, some commentary - appropriated from Dr. Seuss - and the link. There is much to be pleased about here.
Moving into less familiar territory
One of my favorite commentators on the policies and practices at the NIH National Center for Complementary and Alternative Medicine (NCCAM), is noted author and observer of the human condition Theodor Geisel.
Some time ago, noting the NCCAM's penchant for applying reductive, drug
trial methodologies to whole person natural healthcare and integrative
approaches, Geisel wrote:
If I ran the zoo said young Gerald McGrew I'd make a few changes that's just what I'd do.
The lions and tigers and that kind of stuff if I ran the zoo would not be good enough
Theodor Seuss Geisel,
a.k.a. Dr. Suess, never commented on NCCAM, as far as I know. But I would bet that he, or at least his creation, young Mr. McGrew, would no
doubt be pleased with a direction engaged by the NCCAM National
Advisory Council last Wednesday, September 5, 2007. The Council decided
to turn away for a moment from the lions and tigers of randomized
controlled trials (RCTs).
NCCAM laid down a new law for this program: "Clinical
trials are not permitted."
Instead, with an emphatic warning that might have been articulated by
McGrew himself, NCCAM laid down a new law for this program: "Clinical
trials are not permitted." Then, slapping again the trained hand that itches to tame life into another RCT, the NCCAM directive chastens: "Controlled trials will be
considered unresponsive and returned without review."
What sort of research creatures will be found in this program then? Here is the language in the concept paper, prepared by Richard Nahin, PhD, MPH, the program officer in charge: " ... high priority (will be given to) those studies examining the
effectiveness and cost-effectiveness of CAM as practiced in community
settings."
Whole person health care just died and woke up in research heaven.
What might we discover if we actually look at what happens between
integrative and natural health practitioners and their patients? What
might we learn by examining the actual experience that created the
movement that David Eisenberg began to capture and make visible to the mainstream with his 1993 New England Journal of Medicine publication on consumer use? Researching Hot-Tub Claims of Whole Person Practitioners May Interest Healthcare Purchasers
The NCCAM initiative allows into the research arena what I call the "hot-tub claims" of
integrative medicine and complementary health practitioners. Relaxed,
confident, these practitioners will speak of how their patients often have one or more
of these outcomes:
become more functional
gain higher quality of life
diminish their use of pharmaceuticals
suffer fewer adverse effects of drugs
need fewer tests and procedures
limit needs for more expensive conventional services
lower costs of treatment
feel healthier
live with less pain and
find their way to more productive lives.
Not all of these at once, necessarily, mind you. But maybe 2, 3 or
5 of them. Happily, capturing these kinds of claims as potential outcomes -
virtually verboten in most NCCAM programs - are now officially welcome with this NCCAM program.
Notably, such outcomes happen to also be
of great interest to employers, governments and other healthcare
purchasers. As such, they are also germane to discovering whether whole
person approaches may be meaningful to a nation in need of significant
reform of its medical norms. The concept paper (see below) is entitled "Outcomes, Cost-Effectiveness and the Decision Making Process to Use CAM."No specific dollar amount has apparently been set. NCCAM invites investigator initiated proposals.
Whole person health care just died and woke up in research heaven.
A challenge posed by this new zoo, McGrew Zoo, will be in finding
quality health services investigators and then linking them to worthy
whole person, complementary and alternative healthcare practices. Most
of our research zoo keepers were trained by the river of research money
toward RCTs. The experienced CAM-interested health services researcher
is a rare bird.
In truth, this labor shortage is not just a problem for the
complementary and integrative healthcare fields. We need an army of skilled health
services research professionals throughout health care to help us meet
our need to examine practical projects on the
global effectiveness and cost-effectiveness of medical care of all kinds as practiced in community
settings. Otherwise, how do we measure the quality of reform efforts?
But that gets ahead of things. For
now, here is a hope that the integrative medicine community and distinctly
licensed complementary healthcare disciplines, that the interested hospitals and integrative clinic operators, that employers and conscientious health maintenance organizations will make the connections
to take advantage of this rare opportunity to ask questions which might
begin to capture this asserted value. This is a moment to seize.
Send your comments to
for inclusion in a future Your Comments forum.
______________________________________
To access the NCCAM Project Concept Review on hte NCCAM site, click here.
Project Concept Review
Project Title:Outcomes, Cost-Effectiveness and the Decision Making Process to Use CAM
Council Date: September 5, 2007
Program Officer:
Richard L. Nahin
Phone: 301-496-7801
Email:
Background
The last ten years have seen an exponential increase in research
investigating the efficacy and biological basis of many types of
therapies commonly classified as CAM. However, little of this research
has studied CAM as is actually used in a "real world" setting. In
particular, NCCAM's most recent strategic plan
has identified as high priority those studies examining the
effectiveness and cost-effectiveness of CAM as practiced in community
settings. In addition, a recent report from the Institute of Medicine (Complementary and Alternative Medicine in the United States),
recognized gaps in knowledge regarding CAM use and recommended
collecting a range of information regarding "CAM treatments in the
manner in which they are practiced" including clinical outcomes,
cost-effectiveness, patient-provider communication, and the
decision-making process (patient and provider) in deciding to
incorporate CAM into a patient's healthcare plan.
Purpose of Proposed Initiative
This initiative will stimulate the development of observational
studies to evaluate the effectiveness and cost-effectiveness of CAM
approaches as used in the community, and to elucidate the decision
process employed by patients and providers in deciding to use CAM. Such
studies will provide health care providers, patients and policy makers
with additional information on which to base decisions concerning the
incorporation of CAM into an integrated healthcare system.
Objectives
This FOA specifically encourages studies of how CAM therapies
function in actual healthcare settings, where patients may have
multiple problems and utilize multiple therapies, both CAM and
conventional. This FOA emphasizes observational studies and secondary
data analyses evaluating the use of CAM in "real-world" settings.
Examples of the types of projects this initiative could support include
case-control studies, retrospective observational studies, secondary
analyses of existing data, and prospective observational studies.
Clinical trials are NOT permitted under this FOA, and will be
considered unresponsive and returned without review.
Proposed Funding Mechanisms
This initiative will solicit R01 applications only. Applicants
wishing to submit pilot/developmental studies (R21's) are able to do so
under existing FOA's: PAR-07-219 and PA-06-510.
