Frequently Asked Questions About The SPORT Study
About Dr. Subach
Back.com met with Dr. Brian Subach to discuss the Spine Patient Outcomes Research Trial (SPORT) Study. The goal of the SPORT Study is to provide scientific evidence on the effectiveness of spinal surgery therapies versus a variety of non-operative treatments. Below we get Dr. Subach's thoughts on the study:
Back.com:
Based on what you know about the SPORT Study protocol, does the study have any flaws or biases that should concern such groups as patients or insurance providers?
Dr. Subach:
There are three basic—yet critical—flaws that have been discussed in national and international forums: data analysis, generalizability and statistical power.
First: data analysis. The SPORT Study is a prospective, randomized study. To its credit, this randomization will ensure equal distribution of important factors across each treatment group, such as symptom location or severity, duration of pain, etc. Randomization, however, will not specifically control for the independent effect of such variables on treatment outcome. Therefore, any true benefit of surgery may be underestimated or totally obscured. If, for example, surgery clearly benefits those patients with more severe symptoms while patients with milder symptoms benefit more from non-operative care, based on the SPORT Study design it is possible that these benefits will cancel each other out.
Second, generalizability. Based on spine care providers' perceptions and practice patterns, many experts are concerned that a large number of patients with severe symptoms were not referred to the SPORT Study centers. For those patients who were referred to SPORT Study centers, many surgical candidates may not have been offered or accepted randomization, instead requesting surgery. Finally, many patients randomized for the non-surgical route may have been rapidly crossed over to the surgery arm. Such occurrences would clearly underestimate the benefit of surgery in the randomized arm of the SPORT Trial.
Third, statistical power. The issue of power relates to the SPORT Study's use of an "intent to treat" analysis. Specifically, this is a compliance issue since up to 25 percent of patients randomized to non-operative treatment will be non-compliant and will cross over to the surgical treatment arm. Any improvement in this group will be credited to non-operative treatment, which is clearly ridiculous.
Finally beyond the study protocol, I am very concerned the study did not include many of the common standard-of-care technologies that have been introduced since the study closed, including minimally invasive technologies. This is an automatic bias against the modern spinal procedures I perform every week on patients similar to those within the SPORT Study.
Back.com:
What type of non-surgical therapies do you recommend for your patients before you suggest surgery? What is the duration that you recommend?
Dr. Subach:
Though my recommendations are always based the individual patient's condition and lifestyle, I regularly incorporate both traditional and alternative non-operative treatments before surgery. Traditional treatments include anti-inflammatory agents, muscle relaxants, physical therapy, yoga, Pilates, walking, cardiovascular exercises, water therapy and pain medications. Non-traditional treatments include acupuncture and chiropractic manipulation. Most treatments are tried for 6-8 weeks. Injectable steroids are used for refractory joint pain or radicular complaints, but represent a second and slightly more aggressive tier of traditional treatments having both a diagnostic and therapeutic benefit. When combining treatments, we usually allow a minimum of 3 months non-operative care before we discuss surgical discussion options.
Back.com:
The lead investigator of the SPORT Study, Dr. James Weinstein, says too much spine surgery is performed in the U.S. Do you think that's true?
Dr. Subach:
Obviously, opinions vary based upon personal beliefs and experience, and Dr. Weinstein must have some rationale for his statements. To openly make such a negative statement, however, concerns me. When the lead investigator of a study—supposedly designed to find the truth in the matter of non-operative versus operative interventions—introduces such a bias, can he truly be objective in the analysis? Perhaps, "surgeons should use more non-operative interventions in the care of the spinal patient" would be a more appropriate statement.
Back.com:
Will the results of SPORT Study change how you treat your patients?
Dr. Subach:
Probably not. I will critically evaluate the study to see how it relates to my practice. Although it has its flaws, the study deserves to be evaluated on it merits as well as its flaws. I think that our practice treats the vast majority of our patients with non-operative interventions. I know surgery works extremely well in the right subset of patients. I really do not think the issue at hand is the effectiveness of surgery, rather which patients will benefit most from surgery. Unfortunately, I do not believe the SPORT trial is designed to identify those patients.
Back.com:
Is surgery more expensive than non-surgical treatment?
Dr. Subach:
I believe surgery and extended conservative treatment such as injections and physical therapy ultimately may have the same cost. Surgery is unquestionably associated with a greater up-front dollar value, but that cost is often recouped through the length of recovery and ongoing length of results. For example, compare the costs of a patient in conservative treatment for 3 months on a limited work status with the costs of a patient that has a minimally invasive discectomy and is back to work within 48 hours. As a patient, I personally am not interested in suffering and am willing to pay a little more money for a more rapid restoration of health. If one simply assumes that physical therapy, for example, and surgery will have identical physical results, I will guarantee patients will choose a more rapid return to functional status every time regardless of a slightly higher cost.
Back.com:
Could groups such as payers and insurance companies see the SPORT Study and make decisions based off misleading information?
Dr. Subach:
The danger of the broad-sweeping SPORT Study is that it will work against all aspects of spinal patient care. If the SPORT Study labels surgery less effective than therapy for a certain ailment, the duration of physical therapy available to a patient likely will still be limited by the insurer. If surgery is shown to be more effective, surgery authorization likely will still be denied until at least 6 weeks of therapy and anti-inflammatory medications have been tried. Many are concerned the appropriate care may be delayed in order to ensure profits. The SPORT Study could be the most quoted study of the decade, used to deny both imaging and treatment to our patients.
Back.com:
Thanks for talking to us.
Dr. Brian R. Subach is a Board Certified neurosurgeon who is fellowship trained in the treatment of spinal disorders. He is also Board Certified by the American Board of Spinal Surgery and has been granted fellowship by the American College of Surgeons for his work in the area. He is an expert in the diagnosis of spinal disease, and both the non-operative and operative interventions available.
Dr. Subach completed his undergraduate degree with honors from Kalamazoo College and graduated with distinction from the University of Michigan School of Medicine. He completed his training in Neurosurgery at the University of Pittsburgh and his Fellowship in Complex Spinal Disorders at the Emory Clinic in Atlanta. Prior to moving to Virginia, Dr. Subach was Assistant Professor of Neurosurgery and Spinal Surgery at Emory University in Atlanta, Georgia.
Dr. Subach is active both nationally and internationally in the American Association of Neurological Surgeons, and the North American Spine Society, as a member of leadership committees in both organizations; he is a chairman and lecturer in numerous courses regarding the management of spinal disorders; and, is an invited member of the Lumbar Spine Study Group, an international think tank for spinal specialists.
Dr. Subach is the primary investigator in the research performed at Virginia Spine Institute. He is the Director of Research for The Virginia Spine Institute. Dr. Subach is Director of Research for The Spinal Research Foundation. He is Editor-in-Chief of the Journal of the Spinal Research Foundation. He has authored more than fifteen book chapters and published over fifty journal articles regarding his work.
