Jarrod Shapiro, DPM
PRESENT Practice Perfect Editor
Mountain View
Medical &
Surgical Associates,
Madras, Oregon
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Surgical Research —
The Pursuit of Quality
In our last Practice Perfect issue, I established my opinion that the current level of podiatric surgical research is not where it should be. I also mentioned my personal ambivalence in that surgery itself creates significant limitations on research methods. I’d like to continue our discussion and submit a few recommendations of my own. What concrete methods can we employ in both our research studies and our community as a whole, to improve podiatric surgical research? As I mentioned previously, I invite all members of our community, as well as those with research experience, to add your comments to the eTalk section at www.podiatry.com.
If Only We Could...
I’d like to start with another example to bring to light the challenges of doing podiatric surgical research. I
have a hypothetical hypothesis: the Lapidus arthrodesis has better long term success (in terms of long term pain relief and recurrence) for mild to moderate hallux valgus, than the Austin osteotomy. In a world where I could do anything I wanted without concerns for ethical violations, I would randomly assign my patients into 3 groups: Austin group, Lapidus group, and a sham surgery placebo group. Patients would undergo preoperative evaluations, including functional and anatomic studies (like the ACFAS forefoot scoring system). I might then have patients in each group undergo their surgery in a standardized manner (for example, using a template to make the Chevron cut or curettage joint debridement for the Lapidus) using an identical incision for all patients. The postoperative limb would then be placed into a box that prevents them from seeing their foot until their final follow-up. A second surgeon would handle the postoperative appointments, while a separate entity would handle data entry and evaluation. Patients would then be followed at five year intervals for 20 years after the initial postoperative time period.
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But We Can't
Is this possible? Not a chance. What patient would agree to a Lapidus-sized incision for an Austin bunionectomy? What patient would agree to not knowing what procedure they’re going to have? What IRB would even allow that? Is it possible to standardize the procedures? Do you use screws or plates for the Lapidus? Does it matter? How do you handle the postop period? Does that matter? How would range of motion exercises affect the results? When do you weightbear postop? Does that matter? We’re talking here about confounding variables. There are so many variables researchers can not eliminate that it makes this study impossible – at least in this form.
My Inexpert Suggestions
With this example as a framework and statement of the problem, here are a few of my inexpert suggestions to improve podiatric surgical research.
- More research methods education in medical school and residency. We need to improve our understanding of medical research (including statistical analysis) at the beginning – in medical school.
- Required completed research in residency and fellowship. All residents and fellows should be required to complete an actual research project, not a case study or topic review. This may also force all of our residencies to become areas of research excellence.
- Our leading podiatric journals, especially JAPMA and JFAS should require more quality submissions and be more strict about the levels of studies submitted.
- The American College of Foot and Ankle Surgeons should create new research levels for surgical studies that are then published with the study (the same way that JBJS publishes their levels).
- Our leader organizations, such as ACFAS, could create an online research subfellowship where practicing physicians could, via the Internet in a distance learning format, learn how to conduct research and perform the various statistical analyses involved with surgical research.
- Our leading journals could provide a consensus statement similar to a clinical practice guideline that discusses best research methods and most effective literature review techniques.
- Perhaps one of our national leaders, such as CLEAR (Center for Lower Extremity Ambulatory Research), can institute large, multicenter studies that incorporate podiatrists around the country to answer specific surgical questions. Imagine the N for a nationally organized research study. We could finally have a plantar fasciitis surgery study with 10,000 patients or a bunion surgery study with 15000 patients. That would be a well-powered study.
Wishful thinking for a new era in podiatric surgical research? Perhaps. But if we want to see the highest quality studies possible that we can be comfortable adjusting our practice methods as a result of, then changes need to be made. Until then, our students and residents will have to hear us say, “That’s what works best in my hands.” What do you think? Do we need to improve our research methods? If so what improvements would you like to see? Join the conversation.
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Keep writing in with your thoughts and comments or visit eTalk on PRESENT Podiatry and start or get in on the discussion. We'll see you next week. Best wishes!
Jarrod Shapiro, DPM
PRESENT Practice Perfect Editor
[email protected]
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