Archive for June 2011

SPORT and Related Studies of Spine Surgery Outcomes

University of Chicago Neurosurgery Journal Club, June 2011

Edited by: B Roitberg, MD

Faculty: F. Brown, B. Roitberg.

Residents: J. Hsieh, I. Takagi, N. Monim-Mansour, A. Bhansali, J. Khader-Elyias.

1) Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50.

This Spine Patient Outcomes Research Trial (SPORT) evaluates surgery vs. non-surgical treatment for lumbar disc herniation. It is a landmark study, and is perhaps the single most publicized trial evaluating surgical management of back pain in scientific literature today. And as such, the study’s primary conclusion, that there is no difference in outcomes between surgery and non-surgery for lumbar disc herniation, can easily be misinterpreted and misquoted and warrants critical evaluation.

SPORT is a randomized clinical trial encompassing 13 multidisciplinary spine clinics. The lumbar disc herniation study enrolled a total of 501 surgical candidates with lumbar disk herniation and persistent signs
and symptoms of radiculopathy for at least 6 weeks. Patients were randomized to open discectomy or non-operative treatment. The primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity, satisfaction with symptoms, self-reported improvement, and employment status. Groups were compared using an intent-to-treat analysis. After analysis, the study concluded: “Between-group differences in
improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.” However, the devil is in the details.

The crux of the argument around SPORT lies in the intent-to-treat analysis and patient crossover. Say you are doing a study and you have randomized patients into two equal groups: A and B. Now by design, Group A is randomized to be your “Surgery” group and Group B is randomized to be your “Non Surgery” group. No matter what treatment the patient ultimately gets, you will analyze them as to their initial randomization. By doing this analysis, you preserve your randomization and can gauge the outcomes after prescribing treatment (i.e. your intent to treat) regardless of the treatment the patient ultimately receives. This is what researchers mean by “intent-to-treat” analysis.

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