Jarrod Shapiro, DPM
PRESENT Practice Perfect Editor
Mountain View
Medical &
Surgical Associates,
Madras, Oregon
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Evidence-Based Medicine and
Surgery — Incompatible?
Earlier I was reading Dr Meyr’s new eZine, PRESENT Journal Club, and raised my figurative glass in congratulations, not only to Dr Meyr, but also to all of us who once again benefit from our online community. Understanding the scientific literature in depth is a skill most of us – including myself – are weak on. I’m quite excited to see how our community’s understanding and sophistication will progress as a result.
Reading Dr Meyr’s eZine started me thinking about our current level and quality of surgical research. Throughout my career, I’ve repeatedly heard, and often times made, comments about how poor our research literature is. The Cochrane Review, for example, under Interventions for Treating Plantar Heel Pain, states "At the moment, there is limited evidence upon which to base clinical practice." Their search strategy managed to find NINETEEN randomized trials about various forms of treatment for plantar heel pain. I hope you’re not thinking, "Nineteen? That’s pretty good." Is it really? Just think about the vast number of research studies that have been performed in regards to this pathology regarding different methods of treatment.
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Tonight's Premier Lecture is
Hallux Limitus
by Jay Lieberman, DPM, FACFAS |
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Practice Perfect now featuresbrand new lectures on podiatry.com – viewable for CME Credit.
Take advantage of our $60 Introductory Offer,
where you get $$$ that you can apply
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CME Credit on the site. Details are provided at the conclusion of the eZine. |
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Not convinced? Let’s take another quick example. The September 2009 JAPMA edition has an interesting article titled Subtalar Arthroereisis for Pediatric Flexible Pes Planovalgus: Fifteen Years Experience with the Cone-shaped Implant (J Am Podiatr Med Assoc 99(5): 447-453, 2009). I applaud the authors for publishing their experience and contributing to the medical literature. However, the study itself has significant flaws that limit its applicability to surgical podiatry. For example, this is a retrospective study, which makes this at best a level III study according to the JBJS (Journal of Bone and Joint Surgery). Follow this link for an explanation of the JBJS evidence levels. This study is neither prospective (which the authors admit) nor randomized. The procedure was not evaluated against another known treatment (for example orthotic therapy or another subtalar implant). In essence, this study is one doctor’s fifteen years of anecdotal experience with this implant. It’s not a scientific study at all. Now I don’t mean to beat up on anyone. I greatly admire the authors for publishing their results and opening them up to scrutiny. But this points out the problem with doing surgical research.
I’m a bit ambivalent about this subject, because although I’m critical of the current level of research, I’m wondering just how much better surgical research can be? Doing research about surgery is not the same as medical research. I’ll point out some four obvious differences and challenges.
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You can’t blind surgery. Patients, by matter of the consent process, must know what procedure is being done on them – there goes single blinding. Obviously the surgeon must know what procedure is being performed – there goes double blinding. There are ways to adjust for this, of course, but it’s not the same as a medication study.
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You can’t do sham surgery. It’s unethical to pretend to do surgery on someone as in a placebo controlled drug study that uses a sham control. Therefore, our surgical studies must be comparative in nature, pitting the investigative procedure to the "gold standard" (which itself may or may not be proven).
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It’s often difficult to have large enough cohorts to be appropriately powered.
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Surgery consists of many potentially confounding variables that may affect the conclusion. For example, an Austin bunionectomy differs in many ways, based on the surgeon. Hallux valgus in flatfoot deformities differs from that in cavus or rectus feet. Lurking variables are significant and must be eliminated if possible.
Surgical research is vitally important, not only to our patients but also to podiatry as a profession. EBM is here to stay and will be utilized increasingly by insurance companies and lawyers. In order for us to continue to provide best practices and maintain our stature as the experts of the foot and ankle, we must improve our research methods. But how to do it?
Next week I’ll supply some thoughts along this line. I invite all podiatrists with research and statistics experience and those who don’t, to write in with their thoughts. Is it OK to have a study with 15 subjects? What about retrospective studies? Do they prove true evidence for us to make medical decisions off of?
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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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