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Test Tubes and Butterfly Wings
A Model for Systemic Outcomes Research

By Shirley Vanderbilt

Originally published in Massage Bodywork magazine, June/July 2003.
Copyright 2003. Associated Bodywork and Massage Professionals. All rights reserved.



If a butterfly flaps its wings in Beijing, does it cause a dust storm in Africa? You've probably heard some variation of this question. Actually, Edward Lorenz, who theorized this interconnectedness of our universe, used as the title of his 1979 presentation at the annual meeting of the American Association for the Advancement of Science, "Predictability: Does the flap of a butterfly's wings in Brazil set off a tornado in Texas?"1 So what does this have to do with research, massage therapy and bodywork? Everything.

Systems theory, as a concept for our universe and our own human functioning, began taking shape in Western thought during the latter part of the 20th century, spreading from science to psychology to medicine. Sure, its an old concept if you talk to shamanic healers in the Andes, Native American medicine men and gurus of Asia. But in our European-influenced society, heaped knee-deep in modern science and technological division of entities, it was a new idea. Although not firmly embraced by all, this theory is slowly permeating modern healthcare and, in turn, bringing us back to our roots of integrative medical treatment.

The problem in research is this: We currently base our scientific data on methodologies that cling to a medical model generated by a theory of parts. A part of the body, say, an organ, is diseased. Different drugs, modalities, surgeries, etc., are tested as to their effectiveness in curing that specific, diseased part. Integrative medicine, on the other hand, not only approaches the body system as a whole, it also takes into account those systems surrounding and interacting with the body.

The paradigm of traditional clinical research, addressing the effect of one intervention on one facet of illness, is exclusionary to our growing understanding of the systemic nature of life. The challenge of researching complementary and alternative medicine (CAM) treatments within the context of medicine's gold standard of randomized controlled trials was addressed in a previous Somatic Research column (Oct/Nov 2002, "Are We Forcing a Square Peg into a Round Hole?"). Experts rightfully advised us of the need for control groups, randomization and more studies. But in this approach, we are still singling out aspects of a concept, much as traditional medicine would do in using a single drug. If we remove acupressure, as a technique, from the totality of Traditional Chinese Medicine (TCM) and test its effect on a symptom, are we not replicating the linear model of allopathy? As we strive to produce results about the efficacy of CAM, we have still been held to the standards and outcome goals of traditional research.

If we are to embrace this new scientific model of complex systems, an expanded research model is also called for. From the Program in Integrative Medicine at the University of Arizona Health Sciences Center comes a progressive new proposal for what is termed systemic outcomes research. This treatise, published in the Archives of Internal Medicine (January 2002), focuses on the need for a new model for primary healthcare and in so doing, addresses the limitations of a reductionist approach to health outcomes studies. The team of researchers, headed by Iris Bell, M.D., M.D.(H), Ph.D., represents a range of specialties (medicine, psychiatry, psychology, neurology and pharmacology) and includes Andrew Weil, M.D., of the university's National Institutes of Health Pediatric Center for Complementary and Alternative Medicine. In exploring this revolutionary approach, we first start with the team's definition of integrative medicine.


Greater Than Its Parts
Within conventional medicine, we have seen an increasing acceptance of the assimilation of CAM practices into this larger body of standard care. As the study team points out, this still leaves the issue of medicine's focus on "a specific somatic disease process at the end organ rather than on healing the individual person."2 Within the integrative medicine context, that focus is shifted to empowering the person as a whole to facilitate healing from within, through the techniques of both conventional and CAM approaches. Therefore, integrative medicine is not just CAM but incorporates a partnership between integrative practitioners and the patient to "develop and implement a comprehensive treatment plan for issues that extend far beyond the immediate chief complaint and/or conventional diagnostic category."3

Multidisciplinary approaches emerging in many treatment programs and medical specialties have contributed much toward the building of an integrative model. This process has also been influenced by public demand and preference for practitioners who take a more holistic view of healthcare, as is evidenced by the growth of CAM use. And while CAM philosophy has typically emphasized the holistic approach, the addition of CAM techniques and adjunct psychological and behavioral treatment to conventional practice does not fully encompass the intentions of integrative medicine. In delineating the integrative medicine concept, the research team aligns itself with the World Health Organization's definition of health: "Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity."4 This new systems paradigm, in which the whole is more than the sum of its parts, has significant implications for the future of health outcomes research.


Redesigning Research
Combining the philosophies of CAM and conventional medicine is a challenge, as the two frameworks are often at odds with one another. What we usually see in research is a portion of a CAM approach being taken out of context and tested within a reductionist, scientific design to see if it fits into conventional care. Additionally, the traditional research model calls for homogeneity of subjects with a common denominator diagnosis by disease or symptom, while in many CAM approaches, it is not the symptom/disease but rather the person's subtype which determines the appropriate treatment (i.e., homeopathy and Ayurvedic medicine). The study team advocates an approach to gathering samples that "would involve a double selection procedure" for a specific conventional diagnosis and also for a specific CAM system diagnosis. "Research designs that ignore the diagnostic approach of a given CAM system," the team says, "can achieve only weak tests of the intervention program's ability to benefit patients."5 Researchers are not suggesting two separate models, but rather combining conventional scientific standards with "thoughtful designs honoring the philosophical foundations and clinical practices of each CAM system."6 These designs would necessarily address the effect of interventions on the entire system, rather than looking at one specific action on a separate subsystem. As the authors state, "All agents, both conventional and CAM in origin, have in common the likelihood of exerting simultaneous, multiple, interdependent actions."7

Using a system-theory basis for clinical research could lead to what the writers term an "emergent" worldview in medicine, in which the whole is more than the sum of its individual parts. In the classical model, they identify three components contributing to what is generally considered quality healthcare, all of which present a challenge in the study of CAM. Structure has to do with practitioner competency and equipment, which in any CAM treatment can vary from therapist to therapist. Process relates to "the appropriateness of the treatment in relation to its nature and quality," a point of contention because allopathic and alternative values often differ in this area. Then there is the outcome goal. Is it a cure of the disease or promotion of total well-being? Integrative medicine takes the latter approach, generally not addressed in conventional studies.8

In order to assess integrative medicine's "multicausal illnesses, multiple interventions and multidimensional outcomes (bio-psycho-socio-spiritual)" the team says a new research approach requires "multivariate design and statistical techniques." While the reductionist approach has value, its singular use without the systems orientation will only serve, as stated before, to place parts and pieces of CAM into a conventional model while ignoring the emergent properties of the whole system. And in actual clinical practice, authors point out, a single intervention prescribed in isolation is a rarity.9


A New Conceptual Framework
A systems-based research model, as outlined by the authors, can be approached from the domains of outcome design, outcome measures and outcome analysis. Adding additional arms to the well-accepted comparisons of randomized groups is recommended to allow for examination of effectiveness on the whole system, which may be different from that of individual components. In the use of multiple interventions, a multiarm approach could allow for evaluation of a positive combination effect or lack thereof, in addition to evaluating single intervention effectiveness. Additionally, it could discern when excessive overlapping of interventions is unnecessary. An example given by researchers is a pediatric study in which abdominal pain was treated by a fiber diet augmented with a variety of psychosocial interventions. Study results indicated a combination of three psychosocial interventions with the fiber diet was no more effective than adding a singular psychosocial treatment to the fiber diet.10

Individual differences in patient response to any intervention is another factor to be considered in a multiarm approach. We've addressed the need for subtyping according to the CAM philosophy in diagnostic criteria. The authors take this one step further by suggesting subtyping for the individual: "Even before applying the diagnostic subtyping of CAM treatment systems to the same individuals ... Integrative medicine researchers may need to meld the subtyping approaches both from the conventional world (i.e., psychosocial/ behavioral coping styles) and from CAM systems to optimize improvements for the largest numbers of patients."11

The study team also suggests the inclusion of observational or quasi-experimental design as an alternative to randomized controlled studies. Observational studies could lower costs, allow for individualized treatment and serve a broader range of patients. Quasi-experimental design includes use of variables but may lack controls or randomization. However, these designs should be used more frequently, authors note, "because they allow an understanding of how our healthcare interventional world operates in actual practice."12

Outcome measures in systems-based research should go beyond the conventional physiological data to include assessment of psychological, social and spiritual outcome, researchers say. In measuring the systemic effectiveness of integrative medicine, we need to include multidimensional outcome measures that address, in addition to absence of disease, the patient's view of quality of life. This is where qualitative measures can be of value by providing an interpretation of the individual patient's values regarding their own well-being.13

The study team's final recommendation regarding this new model is the use of "state-of-the-art, user-friendly advanced methods of data analysis that enable investigators to test a CAM system as a whole, and within its own context." The authors note there are available methods, such as path analysis, structural equation modeling and confirmatory factor analysis, which would indeed allow researchers to examine "complex relationships among many dependent and independent variables at the same time, consistent with the higher level of organization in a complex systems theory model."14


The Integrative Path
One month following publication of the above paper, another article appeared in the Archives of Internal Medicine addressing changes needed within medical school teaching, practice and research to accommodate a transition to an integrative approach. The words of the authors (physicians Ralph Snyderman of Duke University Medical Center in Durham, N.C., and Andrew Weil of the Arizona study team), very neatly sum up our prospective future: "Fundamentally, integrative medicine is meant to provide the best possible healthcare, for both patient and physician, and the success of the movement will be signaled by dropping the adjective ... The integrative medicine of today will simply be the medicine of the new century."15

Shirley Vanderbilt is a staff writer for Massage and Bodywork magazine.


References
1. Gleick, J. Chaos: Making a New Science. New York, NY: Penguin; 1987.
2. Bell IR, et al. Integrative medicine and systemic outcomes research: Issues in the emergence of a new model for primary health care. Archives of Internal Medicine 2002 Jan 28;162(2):134.
3. Ibid.
4. Ibid.
5. Ibid., 135.
6. Ibid. 136.
7. Ibid., 135.
8. Ibid., 136-137.
9. Ibid., 137.
10. Ibid.,138.
11. Ibid.
12. Ibid.,
13. Ibid., 138-139.
14. Ibid., 139.
15. Snyderman R, Weil AT. Integrative medicine: Bringing medicine back to its roots. Archives of Internal Medicine 2002 Feb 25;162(4):397.




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