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Article Excerpt
Facilitator
Sean Tunis, M.D., MSc., Director, The Center for Medical Technology Policy, a small nonprofit firm; formerly, at Centers for Medicare and Medicaid Services (CMS).
Panel Members
* Carolyn Clancy, M.D., Director, Agency for Healthcare Research and Quality (AHRQ); previously she was Director of the Agency's Center for Outcomes and Effectiveness Research.
* W. David Helms, Ph.D., President and Chief Executive Officer (CEO) of AcademyHealth. He also serves as President and CEO of the Coalition for Health Services, AcademyHealth's advocacy arm.
* J. Michael McGinnis, M.D., M.PP., Senior Vice President and Director of the Health Group at the Robert Wood Johnson Foundation. Previously he served as Assistant Surgeon General, Deputy Assistant Secretary for Health and Director of the U.S. Office of Disease Prevention and Health Promotion.
* Steven D. Pearson, M.D., M.Sc., FRCP. President, Institute for Clinical and Economic Review (ICER) at Harvard Medical School; Senior Fellow, America's Health Insurance Plans in Washington, DC.
Sean Tunis: There is growing interest in building capacity for comparative effectiveness research in the United States. Many people, including but not limited to panelists at this roundtable, have contributed to the increasing enthusiasm and growing consensus that something needs to be done to further build capacity for comparative effectiveness research. Here are a few examples. The Institute of Medicine's (IOM) Roundtable on Evidence-Based Medicine, under Michael McGinnis's leadership, has been facilitating this conversation. A proposal by America's Health Insurance Plans (AHIP) on comparative effectiveness, which Steven Pearson has been instrumental in helping put together, has received a lot of attention on Capitol Hill and elsewhere. Others such as Gall Wilensky (2006) have called for a massive increase in investment in comparative effectiveness.
Similarly, several groups have been active on the issue of comparative effectiveness, including the Blue Cross and Blue Shield Association, the Medicare Payment Advisory Commission, and the Congressional Budget Office. Congressman Tom Allen (D-ME) recently drafted legislation that specified resources to build capacity for comparative effectiveness (H.R. 2184, the Enhanced Health Care for All Act of 2007). Comparative effectiveness surfaced early on in the health proposals of presidential candidates. All these activities reflect an urgent and profound interest in comparative effectiveness research.
In this roundtable discussion, we will try to clarify what falls under the umbrella of comparative effectiveness. One proposed definition of comparative effectiveness (sometimes called comparative clinical effectiveness) is that it is research that compares the benefits and risks of health care option A to health care option B, where option A and B will usually be a drug, device, or procedure. So the first question for our panelists is, Do you agree with this definition, and if not, how would you change it?
Carolyn Clancy: Your question raises several issues. First, you said comparative clinical effectiveness, and I do think that one of the potential flash points is whether we're talking about clinical effectiveness alone, clinical effectiveness with some information about costs, or clinical effectiveness coupled with cost effectiveness.
A second issue relates to what we mean by "options." Many interventions in medicine, whether about diagnosis or treatment, are linked to a series of contingent actions, that is, as part of a strategy or chain of events. We need more clarity around the term "option."
And then, frankly, I think the big issue in setting priorities for this enterprise relates to whether we mean an array of all possible interventions (including no intervention), or are we focusing on specific types of interventions?
Now, to that extent, I would disagree with your definition, because it seems to imply that research must focus on the comparative effectiveness of drugs, or devices, or surgical procedures. As a clinician, I believe that the decisions facing many clinicians and patients actually are, "Given this set of circumstances, what can I do?" Often, clinicians and patients have many different and sequential options embedded in the choices that they have to make. So, when I turn to a definition, I usually turn to the legislative authority that AHRQ has under the Medicare Modernization Act (MMA) (see http://www.hhs.gov/asl/testify/2007/06/t20070612a.html for details). The MMA offers a start and defines health care services broadly based on input from the public and private sectors.
David Helms: AcademyHealth has been preparing for the opportunity to debate this issue publicly, and we have a report on comparative effectiveness options that offers some principles (AcademyHealth 2005). I endorse the idea that we ought to be thinking broadly. This means comparing the range of options for addressing a condition, whether that's a pharmaceutical, a device, a medical therapy, or a combination of those compared with a procedure. I'm pleased to endorse that part of the definition.
Michael McGinnis: We used a very simple definition of comparative effectiveness studies in the IOM work in which we've been engaged. It essentially goes something like, "The comparison of one diagnostic or treatment option to one or more others."
This definition suggests a departure from the one Sean mentioned, in that it allows latitude to compare, whether in diagnostic or treatment categories, across different kinds of approaches. For example, clinicians want to compare the extent to which a computed tomography scan is preferable or not to cardiac catheterization in diagnosing coronary artery disease. Or for example, in treatment; when it comes to adolescent obesity, clinicians do not want to compare only across bariatric surgery approaches; they want to have a sense of the relative effectiveness of bariatric surgery versus lifestyle modification.
Steven Pearson: I'll try to be a little bit provocative. I think that in looking at that definition, which is "benefits and risks of option A to B," it's seductive but dangerous to leave out costs.
We are under an illusion that comparative effectiveness is something easy, where we'll go out and do a trial. Option A will be an easy winner over option B, and clinicians and patients will know instantly what to do. A magic, invisible hand will affect the medical system, and everybody will shift to the superior option.
How often have we actually seen that happen? Not that often. Most of the time, there are eight randomized clinical trials that show conflicting results, and some observational data that seem to point in one direction. One...
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