“Comparative Effectiveness Research (CER) has been with us almost as long as we’ve had physicians and scientists, but it’s more important now than ever before as we face ongoing problems with access and the quality of the care delivered, in a setting of skyrocketing health care costs. Our system is running out of money,” explained Tim Carey, M.D., M.P.H., the director of the Cecil G. Sheps Center for Health Services Research at the University of North Carolina-Chapel Hill.
Carey took on some of the tough issues facing the next generation of CER researchers during his January presentation at the 2011 National Scholars’ Current Issues in Health Policy Seminar at the Robert Wood Johnson Foundation (RWJF) Center for Health Policy at Meharry Medical College in Nashville, Tenn.
“Examining the relative value of various approaches to health and health care is also more important today because we have so many more treatments for single illnesses or conditions. We have eight different statins to lower cholesterol, for example, and at least 10 anti-depressants. It’s very important to understand what works best for patients in terms of cost and effectiveness,” Carey said.
One of 10 health policy experts featured in the Meharry Seminar series, which will run until May, Carey also thinks that CER is affected by changes in the way the population learns about medical treatments. “It’s an increasingly noisy environment in the world of health care today. I often have patients who come in with drug advertisements in their hands. That’s quite a change from several years ago,” Carey said.
Disparities and CER
Reflecting on the Meharry Center’s focus on disparities, Carey also discussed the importance of designing CER research in ways that will make it more effective for assessing how treatments work in diverse populations. “While CER may not always focus exclusively on health care disparities, it is always linked. We know that medical treatments are not allocated equally. Quality and access issues are both clearly involved because when African Americans—to select just one group—receive the same access to certain treatments as other groups, there are still differences in outcomes,” Carey said. “That’s just the beginning. Institutional racism, payment differences, doctor-patient communication—all of these issues are involved.”
“In the United States, the issue is not so much who gets care, but where they get care and the quality of treatment they receive in that part of the health system,” said Carey, an RWJF Clinical Scholar from 1983 to 1985. “I’m part of a national initiative to do systematic reviews with the Agency for Healthcare Research and Quality (AHRQ). When you look at health care across medical settings, you will find, when studying treatments for cardiovascular disease for instance, that African Americans will receive care, but the hospitals they are most likely to be treated in are less likely to have 24-hour cardiac catherization capabilities,” a key factor in the survival of patients who have suffered heart attacks.
“In many cases, we fail to accurately measure the impact of race and ethnicity on the treatment received, especially race, as it’s essentially a social construct and therefore harder to measure. But if you ignore it, you ignore disparities and CER has to get much smarter about analyzing disparities-related issues,” Carey said.
CER and Reform
“CER became very controversial during the health care reform debate,” Carey noted, citing CER as the source of the now infamous “death panels” debacle, because there was a suspicion that comparing treatments would lead to denied care for patients in some groups. During his Meharry session, he made it clear that this is not the goal of CER. “Our purpose is to determine if a treatment works for the average patient, working with the average practitioner, in the average treatment environment,” Carey said. “The purpose is to improve medical practice, to make sure we deliver the right treatment, to the right patients at the proper time.”
To better explain the intent of CER, Carey referred to a recent CER analysis of a treatment for osteoporotic compression fractures. “A common treatment for compression fractures, a serious problem for many elderly patients, is the injection of a type of glue into a deteriorating spinal bone to increase bone strength. The procedure, called vertebroplasty, has supposedly helped tens of thousands of patients get better and it was used regularly until 2009. At that time, two randomized controlled trials reported that there was no significant difference in the healing or improved symptoms in patients who received the actual glue injection or a placebo injection with no glue at all,” explained Carey, who is also an expert on back pain, which was the focus of his research for many years including during his RWJF Clinical Scholar term.
“The trial only included 220 people, so it is possible that the treatment helped a subset of patients who were missed, but it also meant that thousands of people—the average patients—were subjected to the glue injection treatment [unnecessarily]. This was a problem because the glue often migrated to other parts of the body potentially creating other complications,” Carey said. Rigorously evaluating treatments of this type earlier may prevent future problems such as those caused by vertebroplasty.
Improving Comparative Effectiveness Research
In his presentation, Carey made several recommendations for making CER more efficient and useful. “We must recognize that CER is very time consuming and expensive, so it’s important to maintain perspective and create research questions that will produce significant results. We should consider using community-based models to study care to obtain the most effective results for diverse populations. Research must also look at cultural issues to ensure that our results are accurate across the population,” Carey said. “Overall, we must carefully study how care is organized, carefully define what we mean by ‘usual care’ and always ensure that we are seeking outcomes that are genuinely meaningful in people’s lives.”
The Robert Wood Johnson Foundation Clinical Scholars program advances the development of physicians who are leaders in transforming health care through positions in academic medicine, public health and other roles. The program trains clinicians in the program development and research methods that will enable them to find solutions to the many challenges posed by the health care system, community health and health services research.