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• W3048606186 abstract "Commentary Back pain is common and the number-2 reason people seek health care. Stenosis with neurogenic claudication/radiculopathy is severely disabling (quality-adjusted life year [QALY] = 0.5). Spine surgery has had variable outcomes in the past, in part because of variable indications and expectations. The Spine Patient Outcomes Research Trial (SPORT) was the first major attempt at a randomized controlled trial (RCT) comparing nonsurgical and surgical treatment of spinal stenosis in the United States. This was a difficult trial to design and it was very difficult to enroll patients in the RCT, so the study included a parallel observational cohort, which was a novel positive strategy at the time of the trial initiation. At that time (and somewhat still today), nonsurgical treatment protocols were not well established. The SPORT regimen was stepped care, the best-in-class thinking at the time. The regimen used medications, physical therapy, and epidural steroid injection (ESI) in the way that clinicians were usually treating their patients. The trial was challenged by high crossover rates making analysis more difficult. The general consensus is that the trial did provide much-higher-quality evidence on outcomes. RCTs are hard work, but they generate a substantial volume of high-quality data. Investigators want to get as much information as possible out of these efforts. Post hoc analysis of outcomes and variables not prespecified in the trial design is commonly done. Gerling et al. wanted to evaluate the effects of epidural steroids in this cohort of patients, which was a valuable endeavor. What happens when we perform these post hoc analyses of RCT data, evaluating nonrandomized exposures? Stack et al. recently provided a very good description of the methodologic issues associated with these post hoc analyses1. They do not provide the protection from bias that randomization provides. Exposure to the treatment (ESI in this case) differs between groups; thus, they are not equivalent. So how does one analyze and account for these biases? Propensity matching is a strategy that helps. However, it does not account for potentially critical unmeasured variables. Sensitivity analyses can help by demonstrating the magnitude of the effect size. So what does the paper by Gerling et al. tell us? As expected, it is difficult to draw definitive conclusions because there was no randomization for this intervention and there was heterogeneity within the cohorts. What is the goal of ESI in this setting? As a society we are condemning opioids, physical therapy has limited benefit for patients with stenosis and requires substantial compliance, and surgeons are trying to limit the risks of surgery; thus, we try ESI. There are little to no data about sustained long-term benefit or a mechanism of action leading us to expect it. If it provides short-term pain relief, is it worth it? This study provides some experience suggesting that there is no clear harm and no compelling evidence of long-term benefit, but it does not address short-term benefit. Clinicians should continue to use the best available data in conjunction with their own clinical experience to make individual patient treatment recommendations." @default.
• W3048606186 created "2020-08-18" @default.
• W3048606186 creator A5081887841 @default.
• W3048606186 date "2020-08-05" @default.
• W3048606186 modified "2023-09-23" @default.
• W3048606186 title "Epidural Steroids for Degenerative Spondylolisthesis: Good, Bad, or Indifferent?" @default.
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• W3048606186 doi "https://doi.org/10.2106/jbjs.20.00843" @default.
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