VALIDATING PATIENT OUTCOMES IN CLINICAL PRACTICE:
What IFM and the Bravewell Report on Integrative Medicine Have in Common
Very recently (February 2012), The Bravewell Collaborative published a report titled Integrative Medicine in America: How Integrative Medicine is being Practiced in Clinical Centers across the United States (a link to the full report is provided below). Among a number of interesting findings (a few of which are discussed below) is one startling fact: “With the exception of data derived from clinical trials, most of the centers stated that, although they do capture patient outcomes data, they did not have the staff and financial resources to collect and analyze it.” p. 29] It’s almost unimaginable that, in this day of powerful computers on every desk, important clinical evidence remains inaccessible and unexamined. Functional medicine practitioners will recognize that challenge at an even more fundamental level. As yet, patient outcomes data from the practices of functional medicine clinicians are not even captured in any systematic way, let alone analyzed and reported.
One of IFM’s most important strategic goals is the validation of functional medicine in clinical practice; because of IFM’s small size and program-revenue–based funding, it has been challenging to make significant progress on this goal. Learning that even the relatively well-funded academic and clinical integrative medicine centers that participated in the Bravewell study haven’t found the resources to accomplish such a vital goal makes it even more imperative that we look for a mechanism that doesn’t require huge philanthropic gifts or government-funded large clinical trials.
A research model for looking at patient outcomes in real-world clinical practices does exist, and it doesn’t have all the inherent limitations of the randomized controlled trial (RCT). Although applications of the technology are not yet widely available, the underlying science is well advanced and market-ready applications will be forthcoming. We’re talking about the analysis of clinical outcomes via the submission of individual patient information (a comprehensive case report in digital form) to a central database by practitioners on behalf of (eventually) many thousands of patients. If constructed properly, the patient’s data points are tagged and coded on entry, allowing the database to yield information to individual clinicians as well as to scientists.
Imagine being able to enter some basic information for a patient you are treating—let’s say age, gender, and one or more diagnoses—and the database locates a subgroup of 50 or 100 similar patients whose assessment, interventions, and outcomes can be mined for common threads. Perhaps you could find out what laboratory testing is most common for such patients, and what interventions are fairly standard vs. those that represent a more individualized model. You might be able to check on the average length of time from initial treatment to documented improvement. Over time, analysis might reveal which interventions were dropped for lack of effectiveness and which ones were most successful. You could further refine the subgroup selections by entering more initial search criteria. The queries could be as broad or as narrow as you need. How amazing!
IFM is right now exploring the possibility of setting up a digital case report template—a system that functional medicine practitioners will be able to use to enter patient data. When enough cases are in the database, users can log in to search for immediately useful clinical information. Over time, as the database grows, interventions can be associated with outcomes on a much larger scale, and the systematic validation of functional medicine approaches to care will be under way.
IFM will offer its first certification test in mid-2013. Candidates are required to submit two case reports exemplifying their ability to practice functional medicine. If we can provide a case report template that interfaces successfully with the kind of program described above, we will have an excellent initial source of clinical data with which to develop our database. This is a very exciting prospect for the future of functional medicine! Check back here for further reports…Selected Findings from The Bravewell Report on Integrative Medicine in America
A final point.
- Twenty-nine centers participated in the study, which investigated how integrative medicine is practiced and paid for in the U.S. today—at least, how it is practiced in academic medicine and medium-to-large health systems. (For a viewpoint on the much larger group of integrative practitioners not found in those settings, check in with John Weeks’ opinion piece in The Huffington Post; a link is provided below.)
- Services were most often paid for by the patients (that is, cash payments). Insurance did frequently reimburse for acupuncture (62%), integrative medicine consultations (79%), and psychology/psychiatry (59%) services, but considerably less often (or not at all) for other services such as tai chi/qi gong (0%), health coaching (14%), meditation classes (17%), or even nutrition (55%).
- Three types of care were defined; although there is certainly overlap among them, it’s worrisome that less than half the centers (18) offered primary care. The others focused on consultative care (“delivered in collaboration with the patient’s primary care provider”) and comprehensive care (“complete care for a specified condition in which the integrative practitioner acts as the primary caregiver…during the course of treatment). If the nation’s healthcare system is going to become considerably more effective in combatting the epidemic of chronic disease that threatens to bankrupt us, then fundamental change has to reach primary care. How can sufficient numbers of clinicians and patients understand and embrace personalized, lifelong prevention and health-promoting environmental and lifestyle strategies if not through the practice of primary care? We can no longer afford to wait until people get sick—intervention has to happen long before then!
- No data on patient outcomes was available (see discussion above), but self-assessments of effectiveness by the center directors plus patient satisfaction ratings (from surveys and patient comment cards) served as proxies for outcomes data. Interesting findings include:
- More than half the centers indicated they were having success with the same 5 conditions:
- Chronic pain (“the condition for which patients seek integrative care most frequently”)
- GI conditions
- The therapies used most frequently to address these conditions included:
- Nutrition and supplements (the most recommended)(IFM provides high quality continuing education on the use of diet and nutrition in clinical practice; see below for links to an interesting webinar on Controversies in Nutrition: Vitamin D and Iodine and to IFM’s Functional Nutrition Course.)
- Conditions treated “the most similarly” (concordance >.92) included heart disease and hypertension, heart disease and diabetes, hypertension and diabetes, pre-op and post-op care, fatigue/sleep and depression/anxiety, and stress and fatigue/sleep, in descending order of consistency.
- Those treated least similarly were allergies and acute pain, obesity and acute pain, and immune disorders and acute pain.
- Such data notwithstanding, many practitioners reported believing that their treatments were most successful when they addressed the patient’s physical, emotional/mental, environmental, and spiritual needs concurrently.
- Most patients seen were referred from within the centers; few were referred from outside colleagues. Does this reflect a failure of the centers to communicate their unique offerings to the larger community, or does it represent skepticism on the part of that community about integrative medicine? No way to know, but an intriguing question.
The definition of integrative medicine provided in this report is: “Integrative medicine is an approach to care that puts the patient at the center and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person’s health. Employing a personalized strategy that considers the patient’s unique conditions, needs and circumstances, it uses the most appropriate interventions from an array of scientific disciplines to heal illness and disease and help people regain and maintain optimum health.” All of this is important and, happily, functional medicine already encompasses these values and goals. What’s missing from the definition, however—and what functional medicine offers to all practitioners, regardless of discipline—is continually evolving mechanisms and tools for seeking the cause of disease and dysfunction and for individualizing care. Using a systems biology approach, the functional medicine matrix and associated tools make it possible to implement integrative medicine strategies in a systematic, consistent, and effective manner. Without those elements, it will be very difficult to “help people regain and maintain optimum health.”