Federal and private healthcare policy officials and analysts took turns Monday describing the future direction of comparative effectiveness research (CER) in the wake of healthcare reform for attendees of the ATS President’s Symposium, “Comparative Effectiveness Research: What is It and What are the Opportunities and Challenges?”
Caroline M. Clancy, M.D., acting director of the Agency for Healthcare Research and Quality (AHRQ), reminded her audience that CER is nothing new at the National Institutes of Heath (NIH), and in fact, it has been a focus of the federal health research agency for decades. What is different is that CER is now law, following the passage of national healthcare reform and the economic stimulus bill, which provided $1.1 billion in funding for CER at the NIH.
“But we have not done a very good job of developing the comparative information,” said Dr. Clancy. “The aspiration to being able to tailor what we know in science in the care of individual patients is not new, but the underlying evidence to do that is not there.”
In defining CER, Dr. Clancy referred to segments of the definition developed by the Institutes of Medicine (IOM), particularly the reference to “treating, diagnosing, preventing and monitoring health conditions in real world settings,” not in the idealized world of a research center, but as clinical care is actually provided, she said.
The entire goal of CER is to figure out, “how research is going to be applied and how to get people to make truly informed healthcare decisions in partnership with their clinicians,” she said.
Dr. Clancy also described the creation of the Patient-Centered Outcomes Research Institute (PCORI), which will be tasked with setting priorities and coordinating the work of federal healthcare agencies in supporting CER.
Michael S. Lauer, M.D., director of the Division of Cardiovascular Services at the NHLBI, described the forces that drive the national focus on CER.
“One reason that we need CER is we have seen many cases where we have therapies or treatment strategies that are adopted into practice without appropriate evidence,” Dr. Lauer said.
A way to look at the problem is by studying the Dartmouth Atlas map that shows variations in Medicare spending in different regions of the country, illustrating that “there are enormous variations in practice around the United States,” he said.
The only problem, Dr. Lauer said, is that those variations in medical practices, and the resulting varying rates of healthcare spending, do not translate into enormous variations in health.
“Higher rates of spending do not lead to better outcomes,” he said.
Dr. Lauer described research that found that 50 percent of recommended medical practices are based on expert opinion in the United States, but only 11 percent are based on evidence from multiple randomized clinical trials.
In discussing the policy implications of CER, Sean Tunis, M.D., M.Sc., said it is understandable that the American public confused the ideas of CER with healthcare rationing in the current politically charged environment. In this environment, CER must work to create science that is relevant and useful to U.S. healthcare stakeholders, said Dr. Tunis, founder and director of the private, non-profit Center for Medical Technology Policy (CMTP).
“If stakeholders—patients, consumers, clinicians, payers and policymakers—were somehow more influential in guiding the activities of clinical research, this would address reoccurring gaps in knowledge,” he said.
Dr. Lauer also referred to a portion of the IOM definition of CER outlining that science must be most relative to what decision makers need to know when making healthcare decisions.