An Interview With Dr. John Peloza Regarding the SPORT Study

You can imagine conferences like ISSLS keep us very busy reviewing new studies and conversations that will make a difference in how we do our jobs.  The conferences also allow us a good chance to see what surgeons are thinking about new information and happenings within the industry.

Here is an excerpt of my conversation yesterday with Dr. John Peloza, a prominent surgeon and clinical researcher in his own right.  He weighs in on the SPORT trial, its results and its protocols.

Me: So, what were your thoughts on the first round of the SPORT Study results? 

Dr. Peloza:  It wasn't that surprising…frankly, I knew the surgical group of herniated disc patients would have strong results.  Regardless of some of the inherent biases in the protocol, this conclusion proves what many of my colleagues and I already know: spinal surgery can be a viable, clinically proven and safe procedure for those patients who have tried every other option. 

Me: I've heard you mention those biases in the past. 

Dr. Peloza:  Right. A randomized study of this scale should be applauded – no question.  But one big concern I have is the Intent to Treat (ITT) statistical methodology that was used.  Basically, this methodology credits the success of the patient's outcome with the original treatment category that was assigned to them - whether or not this is the treatment the patient received.  So a patient that has been assigned to the non-operative group can switch groups and have surgery, but their outcome will be counted as non-operative treatment.  It's a hard thing to quantify, but it can be a dangerous analysis if used in the wrong way.  We just need to be careful of evaluating the data, but remembering the biases.

Me: We noticed that the success rates in the ITT analysis were very good and seemed to show that the surgery patients did better than the non-operative patients overall.

Dr. Peloza: Yes they did, which is testament to just how strong the results of this surgery can be. Even if the data hadn't been able to overcome the ITT biases, the 'as treated' methodology is much more relevant because it gives us a view of how the patients did with their actual therapy. In fact, this study may be a better review of patient's behavior when they felt they had exhausted non-operative treatment and selected surgery.

Me: So since so many patients from both sides crossed over, the randomization is a moot point?

Dr Peloza: Well, randomization is essential to minimize bias.  In the U.S., it is difficult to do a randomized clinical trial.

Me: Do these results suggest that everybody would have done better with surgery?

Dr. Peloza: Not at all. Each case is unique and requires the appropriate treatment.  Some of those patients who did well with non-operative care probably weren't surgical candidates anyway. This is a decision that is so personal and so unique to each patient that only the patient can decide when they have had enough pain and disability. When they reach that point, they should work with their surgeon on deciding the best surgical therapy.

Me: I spoke with Dr. Michael Longley who was an investigator in the SPORT trial.  He mentioned one very important point about his patients. He said that if people are hurting badly enough, they will get fixed. Agree?

Dr. Peloza: That's actually a great way to put it, yes, I find that as well. Pain and disability affect people at different levels. What one person can live with, another may not be able to handle. The important point is that each patient should have the ability to sit down and evaluate a treatment plan with a doctor or surgeon they feel comfortable with. Without limitations.

Me: Is there ever a danger for these herniated disc patients to wait too long?

Dr. Peloza: Yes, in fact if they have severe or progressive nerve damage then our ability to bring them back to normal diminishes over time. That is why it is important to at least consider a surgical therapy when a patient's experience with conservative care starts to show signs of not working. Don't rush to surgery, but definitely talk it over with your surgeon to understand what your particular condition means.

Me:  That sounds like very good advice. Thanks for your time Dr. Peloza – I appreciate it. It's always good to speak with you.

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I look forward to receiving your comments and questions.  Please feel free to email me, and I will try to respond to your question on the blog.

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