In September 2015, at AcademyHealth’s Concordium 2015 meeting in Washington, D.C., I saw a great presentation by Peter Embi, M.D., who was then an associate professor and vice chair of biomedical informatics as well as associate dean for research informatics and the chief research information officer at the Wexner Medical Center at Ohio State University.
That day Dr. Embi outlined some of the limitations of the traditional approach to evidence-based medicine — that it is a research/practice paradigm where the information flow is unidirectional, and clinical practice and research are distinct activities, with the research design as an afterthought. “We want to leverage information at the point of care and in engagements with patients so we can systematically learn. That is what the learning health system is all about,” Embi said.
But in the current model, he noted, there is little consideration of research during planning of health systems. That limits the ability to invest in and leverage clinical resources to advance research. Also, there are no financial incentives for non-researchers to engage in research. Research as an afterthought also leads to regulatory problems and wasted investments.
Embi argued for moving from “evidence-based medicine” to an “evidence-generating medicine” approach, which he defined as the systematic incorporation of research and quality improvement into the organization. Rather than findings flowing only from research done looking back at historical data, this approach creates a virtuous cycle where clinical practice is not distinct from research.
Flash forward to 2019 and Dr. Embi is now president & CEO of Regenstrief Institute Inc., vice president for learning health systems at IU Health, and chairman of the Board of Directors of the American Medical Informatics Association (AMIA). And he is still advocating for a shift to evidence-generating medicine. He and AMIA colleagues recently published a paper in JAMIA offering more than a dozen recommendations for public policy to facilitate the generation of evidence across physician offices and hospitals now that the adoption of EHRs is widespread.
The paper cites several examples of current high-visibility research initiatives that depend on the EGM approach: the All of Us Research Program and Cancer Moonshot initiative, the Health Care Systems Research Collaboratory, and the development of a national system of real-world evidence generation system as pursued by such groups as the US Food & Drug Administration (FDA), Patient-Centered Outcomes Research Institute (PCORI), National Institutes of Health (NIH), and other federal agencies.
The paper makes several recommendations for policy changes, including that the Trump administration should faithfully implement 2018 Revisions to the Common Rule as well as establish the 21st Century Cures-mandated Research Policy Board. The administration must implement this provision to better calibrate and harmonize our sprawling and incoherent federal research regulations.
Another recommendation is that the HHS Office of Civil Rights (OCR) should refine the definition of a HIPAA Designated Record Set (DRS) and ONC should explore ways to allow patients to have a full digital export of their structured and unstructured data within a Covered Entity’s DRS in order to share their data for research. In addtion, regulators should work with stakeholders to develop granular data specifications, including metadata, and standards to support research for use in the federal health IT certification program.
The AMIA authors also suggest that CMS leverage its Quality Payment Program to reward clinical practice Improvement Activities that involve research components. This would encourage office-based physicians to invest time and resources needed to realize EGM, they say.
Based on the paper’s findings, AMIA is launching a new initiative focused on advancing informatics-enabled improvements for the U.S. healthcare system. The organization says that a multidisciplinary group of AMIA members will develop a national informatics strategy, policy recommendations, and research agenda to improve:
• how evidence is generated through clinical practice;
• how that evidence is delivered back into the care continuum; and
• how our national workforce and organizational structures are best positioned to facilitate informatics-driven transformation in care delivery, clinical research, and population health.
A report detailing this strategy will be unveiled at a December 2019 conference in Washington, D.C.
