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.
From the Departments of *Surgery,
‡Community and Family Medicine, and the
§Clinical Trials Center, Dartmouth Medical School, Lebanon, and the
∥;Department of Economics, Dartmouth College, Hanover, New Hampshire; and the
¶Departments of Medicine, and Health Services, and the Center for Cost and Outcomes Research, University of Washington, Seattle, Washington.
Supported by grants from the National Institutes of Health (National Institute of Arthritis and Musculoskeletal and Skin Diseases and Office of Research on Women’s Health, the Centers for Disease Control and Prevention), National Institute of Occupational Safety and Health (U01-AR45444-01A1), and Agency For Healthcare Quality and Research (K02 HS11288).
Acknowledgment date: August 10, 2001.
Acceptance date: October 15, 2001.
Address correspondence to
Nancy J. O. Birkmeyer, PhD
c/o SPORT/Department of Surgery
Dartmouth Medical School
One Medical Center Drive
Lebanon, NH 03756
The manuscript submitted does not contain information about medical device(s)/drug(s).
Federal funds were received to support this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.