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Pure Blog: NCCAM to Examine "the Effectiveness and Cost-effectiveness of CAM in Community Settings" PDF Print E-mail
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.
whole person research, whole system researhc, whole practice research, cost savings, CAM, cost offsets
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.


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