Federal Coordinating Council for Comparative Effectiveness Research Submission for the April 14, 2009 Listening Session

By the American Association of Naturopathic Physicians

Comparative Effectiveness Research of Naturopathic Medicine Aided by HIT

The American Association of Naturopathic Physicians (AANP) applauds the Obama administration for its commitment to outcomes research and determining best practices. We recommend that this perspective include the evaluation of alternative systems of healthcare. While conventional medicine’s focus on treatment of disease has produced many benefits—especially in acute and life-threatening conditions, its effectiveness for the treatment of chronic disease or the promotion of health is limited. This failure has been a major cause of the out-of-control healthcare costs plaguing the nation.

We propose a project that tests a new model of primary care; one that incorporates the best of what both conventional and complementary and alternative medicine can offer and focuses on prevention, health promotion, and treatment of the whole person. This project involves taking advantage of health information technology and electronic medical records in a practice-based research network (PBRN) containing both conventional and naturopathic medical practice. This PBRN will provide a laboratory to compare “real world” effectiveness and cost-effectiveness, initially in the area of type 2 diabetes.

There is at present a severe shortage of primary care physicians. A number of proposals have been put forth as to how to fill that shortage and many of these are aimed at increasing the number of medical students going in to primary care. However, there are also a number of proposals to utilize the skills of other licensed healthcare practitioners and expand access to patient-centered primary care in both federally funded and private health care offerings—e.g., naturopathic doctors (NDs), nurse practitioners, physician assistants, and health coaches.

Naturopathic medicine is a system and philosophy of medicine that has been in use for over 100 years. The AANP represents licensed naturopathic physicianswho are trained at fully accredited four-year residential medical programs. Graduates of our medical schools serve as primary care physicians and have the same training in the basic and clinical sciences as conventional medical doctors. In addition, NDs receive training in a variety of core treatment methods including nutrition, botanical medicine, homeopathy, pharmacology, physical therapy, and minor office surgical procedures. Some licensed naturopathic physicians are also trained in traditional Chinese medicine, acupuncture and Ayurvedic medicine as well as clinical specialties such as natural childbirth. Therefore, naturopathic medicine and NDs provide the ideal laboratory to test a complement to the present primary-care-deficient model of health care.

Researchers at naturopathic academic clinics initiated a practice-based research network (PBRN) and are proposing to expand this network in collaboration with Oregon Clinical and Translational Research Institute (OCTRI) at Oregon Health & Science University (OHSU), Kaiser Permanente, and the University of Washington School of Public Health. The PBRN will also include a number of naturopathic private practices. The data coordinating center will be the newly established center for clinical informatics at the Helfgott Research Institute, National College of Natural Medicine (NCNM). EMR systems compatible with the data in the OCTRI data warehouse will be implemented at participating naturopathic institutions and practices. The EMR system under consideration is EPIC, the same system as used by OHSU, Kaiser and University of Washington clinics. The Helfgott clinical informatics center will coordinate system and coding compatibility among the ND agencies and OCTRI. It will work with OCTRI to securely archive the growing database while making de-identified and customized datasets available to researchers. The proposal calls first for retrospective and pilot prospective studies to test the feasibility of protocols based on an informatics approach to naturopathic medicine outcomes research and to characterize the populations before going on to more definitive study. If there are positive results with comprehensive treatment, the treatment and the outcomes data can be examined for factors associated with improvement.

We propose as our initial disease focus to study type 2 diabetes (T2D). T2D is epidemic and often inadequately controlled (only 37% in adequate glycemic control) by approved treatments. Nearly half (47.9%) of US diabetes patients also use complementary and alternative medicine (Garrow & Egede 2006; Yeh, Eisenberg, Davis & Phillips, 2002). The Diabetes Prevention Program (DPP) conclusively demonstrated that diet and lifestyle changes could prevent diabetes more effectively in a susceptible population than metformin (58% reduction in incidence versus 31%). The DPP lifestyle intervention used lifestyle coaches and a focus on weight loss and exercise, and although it proved less expensive per case of diabetes prevented than pharmacological management alone, it still presents a substantial cost to implement. ND practices will be used to test modifications to this model that include a primary care setting allowing diabetes prevention to be incorporated into patients’ overall focus on health. It may be even more effective, e.g., through the inclusion of nutritional supplementation (Bartlett & Eperjesi, 2008; Farvid, Jalali, Siassi & Hosseini, 2005; Bonnefont-Rousselot, 2004)), and potentially, more cost-effective.

Diabetes is paradigmatic of endemic chronic diseases for which NDs have specified well rationalized treatment protocols of which the elements, individually, show promise but which have not been tested in combined practice. A pilot comparative effectiveness study of naturopathic medicine in T2D is currently underway in Seattle.

It is also important to stress that this PBRN can be used to test components of primary care that can also be incorporated into conventional practice. Diabetes is an important chronic condition but is only one of many conditions toward which the informatics-based research infrastructure that we propose can be targeted. Once the system is established for diabetes, it can be extended to any health condition. For prevention studies, long observation periods will be required and the informatics system developed under this proposal will be in place for such studies. The functions of the naturopathic PBRN and its data coordinating center will include recruitment of participating NDs, aiding in the selection and implementation of EMR systems, prioritizing research questions and developing research protocols, facilitating ethical approvals as well as the extraction, compilation, analysis and archiving of naturopathic clinical and economic data parallel to standard conventional medical data.

Summary

We propose the establishment and funding of a PBRN that includes both conventional and naturopathic primary care physicians to act as a laboratory to test components, approaches and models of primary care that can include the best of what conventional and complementary and alternative medicine have to offer. The PBRN will initially address Type 2 diabetes, but can also be used to determine the best approaches to general primary care/family practice, pain, and other chronic disease conditions.

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