Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.
Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.
The Case for VA Leadership
A solution to these 2 central dilemmas will result in continued health care improvement and, arguably, meaningful cost reduction through elimination of inferior treatments and optimization of individual patient care strategies. Since the current research culture does not reward such accomplishments, the responsibility for moving forward is left squarely on the health care systems. Said differently, a health care research budget that is a small fraction (5%) of health care expenditures is undersized and too culturally foreign for the task. 1
A critical attribute that enables the VA to promote progress to the benefit of both veterans and taxpayers is an accountable care organization incentive to use a long horizon and invest in opportunities that reduce overall cost and improve outcomes for its beneficiariesover their entire lifespan. Although this feature is common to a handful of other large health care providers (Kaiser Permanente, Intermountain Healthcare, Mayo Clinic), those systems lack the assets fundamental to solution design that are broadly represented across VA medical centers: a staff, culture, and apparatus in support of research at most medical centers; an integrated electronic health record (EHR) for data access; and a patient population receptive to participating in activities that will aid fellow veterans.
The VA is in an excellent position to create an efficient and scalable apparatus to perform comparative effectiveness studies.The Point-of-Care clinical trials program, proposed and championed by the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) and supported by the VA Cooperative Studies Program, embeds low-risk clinical trials directly into the clinical ecosystem with a resultant decreased cost and increased relevance owing to study designs driven by current patient care processes.
This methodology and program is applauded by the Institute of Medicine and the Society for Clinical Trials, and each has invited MAVERIC to present at national meetings and roundtable discussions. 2 Designation as a research “transformative initiative” by the VA Office of Research and Development (ORD) provided sufficient support to culminate in the imminent launch of the first national VA Point-of-Care Clinical Trial—the Diuretic Comparison Study. The VA is proceeding with this trial at 50 VA sites for a significantly lower cost.(VA Cooperative Studies Program study #597, methods manuscript in preparation). Results will inform the optimal initial treatment for hypertension and impact the care of millions of veterans and nonveterans.