Comparative effectiveness research should inform clinical decision making and enhance value for patients and the healthcare delivery system, according to an American Heart Association (AHA) policy statement published online May 11 in Circulation.

The new statement builds on the association's overall recommendations for healthcare reform, which include emphasizing research that addresses gaps in knowledge to improve patient outcomes.

"Determining the comparative effectiveness of interventions provides a potentially useful approach for improving individual clinical decision making and the public's health," said the statement's co-chair Raymond J. Gibbons, MD, a member of the AHA's Advocacy Coordinating Committee. "There are, however, differing views on comparative effectiveness research, which have led to considerable controversy. We felt that our scientific expertise and patient focus could both help to inform this discussion."

The association's recommendations cover four areas and suggest that comparative effectiveness research should:

1. Follow established scientific principles and processes. When possible, efficacy does need to be established through randomized controlled trials. However, sometimes only non-randomized databases are large enough to reflect the effects of clinical interventions in broader clinical situations and more diverse patient populations. Eliminating racial and ethnic disparities is a critical societal goal.
2. Focus on enhancing value for patients rather than minimizing costs. The primary focus should be to inform clinical decisions with the overarching goal of optimizing clinical outcomes and value for patients and society. Research should not be conducted to minimize costs, but rather, should provide additional data to help determine the appropriate alternatives for particular patient populations.
3. Facilitate patient treatment decisions. Research should focus on high-volume, high-cost chronic conditions, establishing the best value for patients. It should address gaps in evidence-based clinical guidelines to supplement, not substitute, clinical judgment in the care of individual patients.
4. Be sustained and sufficiently independent with oversight and support. Any oversight entity should be open to input from all stakeholders and possess sufficient independence to promote credibility, efficiency and the ability to reach important decisions, some of which will inevitably be controversial. Funding should not compete with or replace existing federal support for biomedical research and must be sufficient and sustained to fulfill its potential.

"Expanded comparative effectiveness research that adheres to these principles can continue to have a significant and even greater role in improving the healthcare system in this country," said Gibbons, professor of medicine at the Mayo Clinic in Rochester, Minn., and past president of the AHA. "As an association, we stand committed to working with elected officials and other stakeholders to forge clear consensus on how comparative effectiveness research can best serve the public interest."