Whole systems research

Whole Systems Research (WSR) is a movement started in 2002 to revisit issues of purpose, content, structure, design, and analysis in the medical sciences, with particular emphasis on evaluaton of complementary and alternative medicine (CAM) systems and approaches. It is not so much a coherent philosophy as it is a tapestry of approaches and valuations intended to increase the benefits coming from medical research.

To some extent the WSR movement represents a reaction to the over-valuation of randomized clinical trials (RCTs). The idea is that RCTs have grown in a symbiotic fashion with the development of pharmaceutical medicine, to the point that they are almost exclusively appropriate for testing drugs or drug-like interventions for mass prescription in large health-care systems. One reason for founding WSR was a feeling that the search for specific remedies having specific effects in RCTs makes little sense in much of current CAM research. WSR does not take the position that RCTs are useless, but that they are over-used, and have significant shortcomings, especially for CAM.

The fundamental tenet of WSR is that the research object should be approached as a whole system, whether it be a patient, a family or other social unit, a clinic, a health-care delivery system, or a social and cultural context. One approach to WSR is to try to identify all of the influential variables, at multiple levels of meaning, and especially to evaluate the interrelationships among those variables that lead to the behavior of the dynamic system. Alternatively, one can regard a whole system as being too complicated to analyze given our current state of knowledge, and instead one can design studies to characterize complex and emergent system behaviors. The former path leads to studies involving intensive measurement processes, including integration of qualitative and quantitative methods, while the latter leads to pragmatic studies that focus on potential beneficial outcomes, rather than on how the system works. Regardless of the path, WSR is based on the premise that medical systems are generally too complex to permit good predictions of their behavior based on simple reductionist scientific studies.

Understanding of WSR is best acquired by reading key articles (see below), but here is a simplified synopsis of several themes that have emerged:

1. Focus should be on treatment of individual patients (clinical medicine) rather than on treatment of groups of patients (administrative medicine).

2. There should be consideration of inter-relationships among patients and important others in their lives, especially CAM practitioners and conventional physicians.

3. Emphasis should be on matching the patient to the therapy, implying individualistic treatment approaches, rather than “first-line�?, “second-line�? … sequentialization of treatments that ignore important whole system aspects of the patient.

4. There should be willingness to consider a wide variety of outcome dimensions, including physiological, psychological, spiritual, social, and personal preference/utility, and to recognize that various dimensions will hold different salience for different patients.

5. Clinical research should inform clinical practice, with basic science studies generally following rather than preceding them.

6. Medical whole systems are complex, meaning that there are barriers to conventional analysis and synthesis (and not meaning just that they are “complicated�?), and this is particularly important in CAM.

7. Recognize that the dynamic nature of biomedical systems must be properly included in research design.

8. Qualitative analysis is generally required in order to map out complex and often unanticipated relationships among a system’s components.

9. Question conventional notions of the role of “placebo�? or “sham treatment�? in clinical research, especially for CAM therapies.

10. Value exploratory studies on an equal footing with confirmatory trials.

In general, WSR is an eclectic set of ideas that represents an attempt to make clinical research more relevant to the actual practice of both conventional medicine and CAM. As such, WSR draws on a variety of experiences from other areas of research, while also developing novel study designs.

Readings

 * Ritenbaugh C, Verhoef M, Fleishman S, Boon H, Leis A. Whole systems research: a discipline for studying complementary and alternative medicine. Alternative Therapies 2003;9(4):32-36
 * Verhoef M, Lewith G, Ritenbaugh C, Thomas K, Boon H, Fønnebø V. Whole systems research: moving forward. Focus on Alternative and Complementary Therapies 2004;9(2):87-90
 * Bell I, Koithan M. Models for the study of whole systems. Integrative Cancer Therapies 2006;5:293-307
 * Elder Charles, Aickin M, Bell I, Fønnebø V, Lewith G, Ritenbaugh C, Verhoef M. Methodological challenges in whole systems research. Journal of Alternative and Complementary Medicine 2006;12(9):843-850
 * Jonas W, Beckner W, Coulter I. Proposal for an integrated evaluation model for the study of whole systems health care in cancer. Integrative Cancer Therapies 2006;5:315-319
 * Fønnebø V, Grimsgaard S, Walach H, Ritenbaugh C, Norheim A, MacPherson H, Lewith G, Launsø L, Koithan M, Falkenberg T, Boon H, Aickin M. Researching complementary and alternative treatments – the gatekeepers are not at home. BMC Medical Research Methodology 2007;7:7