Design of the Spine Patient outcomes Research Trial (SPORT).

SUMMARY OF BACKGROUND DATA The Spine Patient Outcomes Research Trial (SPORT) was designed to assess the relative efficacy and cost-effectiveness of surgical and nonsurgical approaches to the treatment of common conditions associated with low back and leg pain. OBJECTIVES To describe the rationale and design of the SPORT project and to discuss its strengths and limitations. STUDY DESIGN Descriptive. METHODS First, the authors explain the rationale for embarking on SPORT, i.e., deficiencies in the existing scientific knowledge base for treatment of these conditions. Second, the authors describe the design of SPORT, including topics such as specific aims, participating sites, study population, recruitment and enrollment, study interventions, follow-up, outcomes, statistical analysis, and study governance and organization. Finally, issues that complicate the performance of randomized trials in surgery as they relate to the design and conduct of SPORT are discussed. RESULTS The SPORT project is being conducted at 11 clinical centers around the United States. It involves the simultaneous conduct of three multicenter, randomized, controlled clinical trials. The study includes patients with the three most common diagnoses for which spine surgery is performed: intervertebral disc herniation, spinal stenosis, and degenerative spondylolisthesis, and it compares the most commonly used standard surgical and nonsurgical treatments for patients with these diagnoses. By the end of enrollment the authors anticipate a total of 500 patients with intervertebral disc herniation, 370 patients with spinal stenosis, and 300 patients with degenerative spondylolisthesis in the randomized trials. Patients who meet the eligibility criteria but decline to be randomized are invited to participate in an observational cohort study. Patients are being followed for a minimum of 24 months with visits scheduled at 6 weeks and at 3, 6, 12, and 24 months. CONCLUSIONS The results of this study will provide high-quality scientific evidence to aid clinical decision-making and improve treatment outcomes for these common, costly, and, in some instances, debilitating conditions.