Did a top surgeon perform a nonrandomized, semi-prospective, historically controlled clinical trial without IRB approval or patient consent?
I don’t want to only pick on interventional cardiologists. Last week I wrote about a breathtaking case of interventional cardiology hubris. In response a prominent interventional cardiologist shared with me a fascinating anecdote about cardiac surgery. Here’s his story:
In the early days of minimally invasive CABG, a top cardiac surgeon at a top hospital decided to try out the new technique. He then performed many of his cases this way. He meticulously documented the results, obtaining an angiogram on each and every patient immediately after surgery. After about 80 or so cases, he recognized that his results were better with traditional open CABG, he modified his approach, and ultimately, reverted back to standard CABG via a median sternotomy. The surgeon did not seek IRB approval, nor did he seek approval of insurance companies to incorporate an immediate post-operative angiogram, though presumably he explained to the patients that they were going to undergo a new, less invasive operation. As far as my source knew, no one every raised a question about any of this, though my source said that he couldn’t help thinking to himself how different things are on the cardiology side of things. He joked that if he had wanted to demo a new type of surgical glove, he would have been required to get IRB approval.
Here are my questions about this fascinating story:
Do you see anything unusual here? How common is this? (I suspect this sort of thing happens all the time at many hospitals.)
Should the surgeon have been required to obtain IRB approval with this large a change from the standard operative approach?
Should the surgeon have educated his patients and given them a choice?
Should the surgeon have been required to enroll patients randomized into a clinical trial evaluating the two surgical procedures?
Would it be accurate to describe what the surgeon did as performing his own nonrandomized, semi-prospective, historically controlled clinical trial without IRB approval or patient consent?
Is this a good example of eminence-based medicine? Is this a good example of a positive instance of eminence-based medicine?
What do you think?
Among the many well deserved criticisms, I will say it is refreshing to know the surgeon rejected his own hypothesis.
if a physician is authorized to to a procedure, then it is reasonable for her to assess her own skill and results. All surgeons should examine their results to make sure they are doing their best for their patients. That’s not a clinical trial or hubris. It’s good surgical practice.