The Spine Patient Outcomes Research Trial results for lumbar disc herniation: a critical review.
The long-anticipated results of the Spine Patient Outcomes Research Trial (SPORT) were recently published in the Journal of the American Medical Association. In this trial the investigators compared operative and nonoperative care in patients with symptomatic lumbar disc herniation. Despite the expenditure of several million dollars on this multicenter, prospective, randomized, controlled clinical trial, the SPORT investigators admitted, "conclusions about the superiority or equivalence of the treatments under study are not warranted based on the intent-to-treat analysis." In the present article the author provides a critical review of the SPORT formulation and hypothesis, study design and methodology, and results and interpretations in an attempt to explain why the authors of this study were unable to assess the study's only intended null hypothesis that there would be no difference in outcomes between operative and nonoperative management of herniated lumbar discs. Issues related to misrepresentation and misinterpretation of the SPORT results for herniated lumbar discs are also assessed.
McCormick
Paul C
PC
Department of Neurosurgery, Columbia University College of Physicians and Surgeons, New York, New York 10032, USA. pcm6@columbia.edu
D006801:Humans; D007405:Intervertebral Disc Displacement / Q000628:therapy*; D008159:Lumbar Vertebrae; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D012106:Research; D012107:Research Design