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Jarrod Shapiro, DPM
Practice Perfect Editor
Assistant Professor,
Dept. of Podiatric Medicine,
Surgery & Biomechanics
College of Podiatric Medicine
Western University of
Health Sciences,
St, Pomona, CA |
Comparative Effectiveness Research:
Is This the Future?
I’ve recently heard rumblings about the future direction of medical research. As we’ve all heard, entitlement programs such as Medicare and Medicaid are potentially on the chopping block as one way to help balance the budget deficit. As a result of the excessive cost of health care in the United States we’re seeing an increasing push towards research that answers the medical/scientific question but incorporates economic cost/savings into the equation. I wonder where podiatric medicine, biomechanics, and research will fall into this research spectrum? What exactly does comparative effectiveness research mean for us?
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Comparative Effectiveness Research(CER):
What is it?
I can hear the yawns starting. Before falling asleep, let’s frame this type of research in context. You see, no matter how boring the term, CER can potentially have a huge positive or negative effect on our careers.
Here’s a reasonable definition from the Effective Health Care Program:
| Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care. |
In essence, this is a systematic review of a particular set of treatments for a specific disease process. A comparison is then made with a judgment of best options, incorporating cost of treatment. Click here for an interesting example comparing various options for the treatment of osteoarthritis. Recommendations are made with a level of confidence indicated based on the current research evidence. What is significant about this summary paper is the cost analysis at the end. This analysis empowers the provider to first consider the most effective treatment for osteoarthritis, as well as important potential complications from these drugs, and then determine the cost effectiveness of various drugs within and between classes.
What are the Benefits?
The benefits are pretty obvious. A systematic review provides a high level of evidence, while allowing us to choose the least expensive, but still safest option, weighing the benefits and the risks. This has the potential to lower the cost of healthcare delivery using cheaper but still effective methods of care. This type of research also provides a useful venue to prove the cost effectiveness of certain types of care. The most obvious podiatric application is in diabetic limb preservation. Not only can we use CER to prove the decreased medical costs as a result of current limb preservation methods, but we can also use it to provide a clearer organizational approach to comparing current methods. This would provide the average wound care specialist THE highest yield method to use to treat a particular patient.
What are the Disadvantages?
The downside to this type of research is where I’m more concerned. The cost of this type of research is obviously an issue. CER must itself demonstrate that it will lower the cost of health care. Luckily, since CER is essentially a suped-up systematic review – a much cheaper research method than a randomized controlled trial – this shouldn’t have a major detrimental effect on the health-care system in general.
The part I’m more worried about is in the realm of reconstructive foot and ankle surgery. We have so many problems with the research behind reconstructive procedures that I cannot see CER working out in our favor. One needs only to read any Cochrane review article pertaining to foot and ankle surgery to see the repetitive “more high quality studies are necessary” line.
I’m concerned that once these studies are done and a cost benefit analysis is performed, we’re going to have a very hard time justifying much of what we do. Let me give 2 quick examples to illustrate my point. Let’s say you want to do a first MTP joint arthrodesis using a compression screw and a locking plate. Unfortunately, the insurance company has not seen any Level 1 CER studies that demonstrate that a locking plate is superior to a non-locking plate or crossed screws for patient satisfaction or complication rates. Even worse, the cost of a locking plate is significantly higher than the other options, and now the insurance company wants to limit what device you can use.
The second scenario entails the 25 year-old patient for which you tried to schedule a flatfoot reconstruction. I say tried because the research into surgery for flatfoot deformity was never able to determine just which of the procedures was most effective. Since the majority of flatfoot reconstructive surgeries include more than one procedure, no one’s able to state with scientific certainty which one of them actually resolves the pain. Couple this with the fact that most of our surgical literature is retrospective in nature, and you have a recipe for denial of coverage.
Where Do We Go From Here?
Whether we like it or not, comparative effectiveness research is likely to become much more influential in the future. And as with all new things, we have the opportunity to make it work for us. This would mean improving our research methods to provide better evidence for our care. Of course, if we continue with the status quo, we will have allowed CER to work against us. Since it’s already becoming increasingly difficult to be adequately reimbursed for what we do, I can only imagine just how bad it will get. Best wishes.
Keep writing in with your thoughts and comments. Better yet, post them in our eTalk forum. Best wishes.
Jarrod Shapiro, DPM
PRESENT Practice Perfect Editor
[email protected]
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