Now consider a woodworker who imagines a new joint designed to build stronger drawers. He doesn’t take his idea straight to the factory for mass production of drawers.
Instead, he builds one drawer.
Using his finest woodworking skill he precisely executes the design. Then he tests the drawer. He may find that he is on the right track, but a couple of changes will make the drawer better. So he builds another one and adjusts his technique. He may build many drawers, perfecting his new joint each time. As it improves, other woodworkers copy the design and add their own unique ideas and skills to it. Eventually, manufacturers decide to use the perfected joint design on a mass scale.
This is often how it goes with surgery. A surgeon sees a problem and uses his years of experience and skill to try to solve it. Over time, he improves his approach. Other surgeons borrow his idea to help their own patients. After years and much practice, the surgeon perfects the procedure. A remedy exists for a problem that once had no solution.
Brett E. Youngerman, MD, a Columbia Neurosurgery resident, and Guy M. McKhann II, MD, Director, Epilepsy and Movement Disorder Surgery, address this process in the January issue of the American Medical Association Journal of Ethics. Their article, Innovation in Surgery and Evidence Development: Can We Have Both at Once?, addresses the difficulty of pursuing both innovation and evidence in surgical treatment.
Drs. Youngerman and McKhann explain that evidence-based medicine uses research to guide treatment decisions. Most surgical subspecialties endorse the evidence-based approach as ideal. But the very nature of innovation means there is not yet research to guide that choice.
So what about our woodworker? He doesn’t have a randomized, controlled study to help him decide if his drawer design will work. And neither does the surgical innovator. Drs. McKhann and Youngerman point out several reasons that surgery doesn’t always fit into the evidence-based model.
First there are many variables that make it hard to determine why a procedure works or doesn’t work. Let’s say you have 20 surgeons studying a procedure at 20 different hospitals. Surgical technique, facilities, anesthesia, and post-operative care will all be different. If some patients don’t do well, how will the surgeons know if it’s the procedure that’s the problem? It could just as easily be one of the other factors. There isn’t a good way to control for these differences when studying something as complex as surgery.
The article also notes the importance of blinding in well-designed medical research. In a blinded trial, patients and physicians don’t know who receives the treatment and who receives placebo. For obvious reasons, this usually doesn’t work for surgery.
Finally, surgical trials often end up with low numbers of patients enrolled. Experimental medications are tightly controlled making participation in research the only chance a patient has to get the new treatment. But a surgeon and his patient can often choose an experimental surgery without restriction. Why would a patient choose to take part in a randomized trial where they may or may not receive treatment?
These factors make it seem that evidence and innovation cannot coexist. But Drs. McKhann and Youngerman have faith that innovation itself can transform the evidence-building process. Large-scale data is now available to surgeons through coordinated nationwide data collection. Surgeons are attempting new study designs to build the body of evidence. Public policy and financial support for answering clinical questions are growing.
As these developments mature we will begin to see innovation and evidence come together to find the answers.
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