What do we know?
How do we know it?
Evidence-based medicine…evidence-informed practice…patient-centered care…the art of medicine.…
These terms fly around the landscape of integrative health and medicine with the potential to ultimately generate a meaningful consensus and a shared language for how we discuss clinical decision-making and clinical practice. With as clear a shared vision as we all know we have—that the empowerment and well-being of the patient is our ultimate goal—it should be easy to reach agreement on what we know and how we know it. In fact, the now inexorable progress toward a true interprofessional approach to care requires that we find a way to reach that agreement.
But more often than not, the discussion around evidence and knowing degenerates into a Tower of Babel.
This is an excerpt from an editorial I wrote with John Weeks recently for the journal Explore on the role of evidence-based medicine in helping establish sensible clinical approaches in the relatively new field of integrative medicine.
The main conclusion of the piece is that there’s a need for new strategies for generating knowledge—hence the term “evidence-informed practice.” The idea is that the traditional evidenced-based medicine approach of relying heavily on randomized double-blind placebo-controlled studies to establish “truth”—which has been effective in the study of pharmaceutical interventions—needs to be broadened to accommodate the highly individualized, difficult-to-control-for and sometimes impossible-to-blind nature of complementary/alternative and integrative therapies.
New Einstein Center to Measure Effectiveness of Complementary Treatments
Recently, Albert Einstein College of Medicine was awarded a grant from the Bravewell Foundation to become the new coordinating center for BraveNet—a practice-based research network of 14 integrative-medicine sites around the U.S., established in 2007.
With a new Patient-Centered Outcomes Research Institute (PCORI)–funded acupuncture trial as well, Einstein is suddenly at the forefront of the discussion about what constitutes meaningful evidence in this field. BraveNet’s largest current project is PRIMIER, a data-registry project that currently has almost 2,000 patients enrolled across the 14 integrative medicine sites and that aims to collect patient-reported outcomes, provider input and extracted electronic health-record data into a large data set examining the impact of the integrative healthcare approach to a wide variety of health problems.
Capturing Data about Integrative Medicine
This data set will be used for quality improvement, evidence-based research and determination of best practices. Although practice-based, observational research like this is difficult—even messy at times—and cannot provide the same kind of crisp and clear answers that a randomized clinical trial can regarding medication efficacy, it captures data about the practice of integrative medicine in the real world, with all its complexity.
If we are successful in enrolling enough patients in PRIMIER—which is planned to continue through 2018 and hopes to reach 5,000 or more patients—these real-world answers will be a new and important way to base our decisions about clinical practice on real-life outcome data.
The new PCORI-funded acupuncture trial—“Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment,” or AADDOPT—represents another unconventional approach to finding “truth”: comparative-effectiveness research. In this study—which has no placebo control group—we will enroll patients with chronic pain from the Montefiore Ambulatory Care Network and randomize them either to individual or to group acupuncture treatment.
Group or “community” acupuncture is a new, potentially cost-effective approach in which six to eight patients sit together in a room and receive acupuncture from one acupuncturist, potentially adding the benefit of group support to the benefits of acupuncture treatment. Although community acupuncture is popular now because of its low cost, no one has adequately evaluated its effectiveness—which we will do in this new study.
Like practice-based research, comparative-effectiveness research is a strategy gaining ground as we try to do research that resembles more closely the actual world of clinical practice.