Interpreting Surgical Trials With Subjective Outcomes
Avoiding UnSPORTsmanlike Conduct
- David R. Flum, MD, MPH
- Author Affiliations: Department of Surgery, University of Washington, Seattle. Dr Flum (daveflum@u.washington.edu) is Contributing Editor, JAMA.
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- DATA INTERPRETATION, STATISTICAL
- DISKECTOMY
- LUMBAR DISK DISEASE
- OUTCOME ASSESSMENT (HEALTH CARE)
- PAIN
- RANDOMIZED TRIALS
In this issue of JAMA, 2 articles1-2 report results of the Spine Patient Outcomes Research Trial (SPORT). One study is a multicenter trial1 of patients with persistent disk-related pain and neurologic symptoms randomized to undergo diskectomy or receive usual care (most often, patient education, anti-inflammatory medication, and physical therapy, alone or in combination). Because the investigators expected high rates of refusal of randomization based on the differential risk of these 2 treatment strategies, they developed a parallel observational study of patients who qualified for the randomized trial but refused randomization.2 Patients in both the randomized trial and the observational cohort study were similar in almost all characteristics and were followed up in a similar fashion for 2 years.
The SPORT randomized trial had such a high proportion of patients who crossed over between treatment strategies (45%-60%) and such a significant degree of missing data …
