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June 14, 2006
SPORT Study Results AnnouncedThe first results from a study by the National Institutes of Health (NIH) were released today at the International Society for the Study of the Lumbar Spine meeting in Bergen, Norway. The study is called the Spine Patient Outcomes Research Trial (SPORT). It's a five-year, $13.5 million, government-funded study that analyzed the treatment of three types of spinal patients:
Today's presentation reported results for the herniated disc patients and shows patients who have back surgery for lumbar herniated discs have substantial improvement in such key indicators as bodily pain, physical function and disability. Read the abstract for today's SPORT Study results. Dr. David Polly, chief of spinal surgery at the University of Minnesota, is in Norway and watched today's presentation. We spoke about the results this morning on the phone. Here is a portion of our conversation: Me: Dr. Polly, thanks for taking some time to talk to me about the SPORT Study results. Are you surprised by the great outcomes for the herniated disc surgery patients? Dr. Polly: No, it's not surprising to me that the surgery patients in this study did so well. Based on the study protocol, I have had some concerns that this study has methodological challenges that could skew the outcomes toward non-operative care. But even with inherent biases toward non-operative care, the early statistics show what a great therapy option surgery is. Jill, as one of these herniated disc surgery patients, are you surprised by the results? Me: I'm not surprised at all. Everyday I'm so grateful that I made the decision to have surgery. I really felt that I gave every effort to the non-operative protocol that my surgeon and I had developed together, but it just didn't work for me and my individual condition. And surgery – from the moment I woke up and the 9 months since – has truly made a huge difference for me. Frankly, it gave me back my life. In looking at the SPORT Study abstract, I was struck by some of the terms used to describe pain. In fact, the term "sciatica bothersomeness," somewhat offended me as a patient. In my mind, a paper cut is bothersome…but radiating leg pain was disabling for me. I have a feeling that for the surgery patients in the SPORT study, "bothersome" didn't accurately depict their descriptions either. A person with "bothersome" pain, perhaps isn't a true surgical candidate in the first place. Dr. Polly: I agree with you. Herniated disc patients with radiating leg pain are in a great deal of pain and are forced to give up their quality of life. The pain relief after surgery can be dramatic and help them get their life back. Me: In the abstract they referenced a "29% crossover" from the non-operative category to the surgery category. What does that mean? Dr. Polly: In the study, patients were randomized into either the surgery category or the non-operative category. If a person was enrolled into the non-operative category, and decided they really wanted surgery, they could "crossover" to surgery. It would have been unethical for surgeons to keep them from the surgical therapy especially if they felt that the non-operative therapies weren't improving their pain and function. According to Dr. Weinstein's presentation, 29% of the non-operative patients crossed over to surgery after failing non-operative care for 3 months. This was larger than we had expected. Dr. Polly: Jill, your herniated disc surgery was a little different, right? You had a minimally invasive discectomy. The SPORT Study surgery patients had a traditional, open procedure. Me: That's correct. I had a less invasive, more modern spinal procedure than the SPORT Study patients. Not only is my scar smaller, but I have a feeling that when we have a chance to review the full data set of the SPORT study, we will probably see that my length of stay was shorter, because I didn't spend the night in the hospital. And, I'm wondering if my recovery time will be more consistent with what Chicago, Ill.-based Dr. Richard Fessler found with his more modern, minimally invasive patients that he reported at the American Association of Neurological Surgeons (AANS) meeting in April. Dr. Polly: Are you referring to the abstract and poster that reviewed 87 minimally invasive herniated disc patients at 18 months post-op? Me: Yes. In fact, he showed an average 21.4 point reduction in ODI scores, which means that there was a greater than 50% improvement from pre-operative scores. Dr. Polly: We are seeing better and better patient outcome scores as we see the data on modern spinal surgery results being presented and published. It may be important to note that the AANS abstract was not a randomized trial, it was an observational study. However, it will be published later this year, and you can review it on the AANS web site. Me: Were there any other comments that you wanted to make about Dr. James Weinstein's SPORT Study presentation? Dr. Polly: This study was clearly a good effort and I really applaud all of the investigators' hard work. Any randomized trial is difficult to conduct. Developing a fair and balanced protocol, enrolling willing and compliant patients, collecting the data and interpreting the data are difficult and sometimes complicated activities for any study. Me: It is our understanding that there was a preliminary review of the one year economics of caring for herniated disc patients in the SPORT Study. I'm almost afraid to ask the results, because I know how much money I spent exhausting non-operative care, not to mention the indirect cost of missing work combined with the cost of the actual surgery. My initial guess is that if you look at my costs within a short time frame – such as a year – that it would seem higher than if you would have considered my cost over time. My benefit from surgery, in my mind, is so great, that comparing the economics in such a short time frame, is a rather ridiculous comparison. Am I missing something? Dr. Polly: You make a good point. This part of the study may be less relevant to patients who could benefit from this surgery. You recall how much pain you were in and how much of your daily activities you gave up. So, the economic value analysis may not impact your decision to have surgery depending on your insurance plan. Me: So, what was the purpose of the economic analysis in the SPORT Study? Dr. Polly: My impression from the poster exhibit at the ISSLS meeting is that the researchers were attempting to make a valid and quantifiable comparison of the costs. As you know, more than $150 billion a year is spent on back pain, even though less than 5% is spent on surgery. However, because of the magnitude of the initial costs, I believe that they were trying to learn something of value. And, realize it is complicated when you apply statistical methodologies to the economic equation. For example, they only looked at the first year of costs, which means that the surgery patients who were required to exhaust non-operative care prior to surgery not only had the non-operative costs, but they also had the costs of surgery. I'm thinking that the poster was only a snapshot from the preliminary data set, because the appropriate way to analyze this would involve a statistical modeling over at least 5 years. I suspect that at two years the economic benefit of surgery will be greater. At the end of the day, I think the surgery is still a cost-effective way of treatment, if an appropriate, objective analysis is performed and a patient's physical and social well-being and quality of life are valued. Me: Thank you, Dr. Polly, for your on-site report on the ISSLS activities and have a safe flight home. --- Later this week we will be featuring conversations with other experts in the spinal industry so that we can give our readers a chance to review additional opinions on this topic. If you have any comments about today's blog, please email me. About InsideSpine.com | Contact Us | Medtronic.com
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| Published: June 14, 2006 | Last Updated: August 12, 2006 |
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