This story reports on two studies published simultaneously about low back related problems. It’s worth noting that although both studies concern back surgery, the medical problem they address is not back pain. Back pain may attend these conditions, but the primary concern is relief from leg pain–the radiating symptoms that travel down the buttock, below the knee, and occasionally into the foot.
In addition to a headline and lead sentence that mislead on this score, the news story fails to accurately characterize the nature of the evidence in the two studies it reports. It also does not quantify the benefits of the treatments the studies explore. These lapses are especially important in the second study about treatments for people who had degenerative spondylolisthesis (DS) with associated spinal stenosis. One in a series of studies from the multicenter SPORT investigators, this study involved two different cohorts distinguished by their treatment preferences. One large group consisted of people who agreed to be randomly assigned to either surgery or nonsurgical care—either was fine with them. The other group consisted of people who chose their treatment. The news article fails to mention this. The randomized trial was essentially invalidated when 40% of patients assigned to nonsurgical care changed their minds and decided to have surgery. Though this might seem like a technicality that only a methodologist could love, “crossovers” make it very difficult to estimate the true effect of a treatment. Indeed, when the authors analyzed the randomized patients according to the group to which they were assigned (“intention-to-treat analysis”), they found no differences in the outcomes of the surgical and nonsurgical patients. When they analyzed patients according to the treatment they actually received (“as-treated analysis”), they saw a big difference. Richard A. Deyo, MD, suggests in his editorial that the truth probably lies somewhere in between. The news article also failed to mention that the people who received nonoperative care generally showed “moderate” improvement (a term quantified by the researchers in both relative and absolute estimates). If the article had explained more, readers might have come away with a more nuanced message about the efficacy of surgery for this unhappy condition.
The story’s succinct, single paragraph about the first study, comparing treatments for leg pain (sciatica) caused by a herniated disc, captures the essence of the study when it says that people suffering with sciatica “might want to wait and see” before deciding to have surgery. There is a good chance they will feel equally improved after a year regardless of whether they try surgery or nonoperative treatments. But when the story correctly points out that people who had surgery “got better faster,” it neglects to say how much better or how much faster—important information. For example, patients actually had worse disability scores at 4 weeks if they had disc surgery. The greatest advantage for surgery was between weeks 8 and 12, and surgery continued to speed recovery only through week 36. Those who waited to have surgery experienced similar improvement. As Deyo suggests, there needn’t be a rush to surgery. “There does not seem to be a therapeutic window that closes quickly.”
None of this would matter if all treatments were equally inexpensive and risk-free. But they aren’t—and the news story misses on this score as well. A simple mention that treatment decisions have trade-offs–in dollars or in lost productivity—would be helpful. A note on the potential harms would help, too. Were patients enrolled in the studies harmed by any of the treatments they received? Are any of the treatments known to have long-term harms that might not show up in these short-term studies? Is fusion benign? Fusion intentionally eliminates movement in the fused segment of the spine, which can add extra stress to the segments above and below. This added stress often creates its own problems and triggers additional fusions. People should know that, too.
HealthNewsReview.org often points out that articles do not need to be long to be complete. In this case, that may not be true. Degenerative spondylolisthesis with spinal stenosis is a complex problem, its treatment is potentially harmful, and the study designed to evaluate the condition was fairly complicated. Herniated discs are less complicated, surgery to treat them potentially less harmful, and the study evaluating them less complex. Though the article made a good faith effort to cover a lot of difficult ground, its 487 words may have been destined to fall short.
We continue to plead with editors to give such complex stories more time and space.
The study does not mention direct or indirect costs (such as loss of productivity), a significant oversight when comparing surgery to nonoperative treatments.
The story says that patients with sciatica got better faster if they had disc surgery. But it does not say how much better or how much faster—very important information. For example, patients actually had worse disability scores at 4 weeks if they had disc surgery. The greatest advantage for surgery was between weeks 8 to 12, and surgery continued to speed recovery only through week 36. The story also does not quantify the benefits of treatment for patients enrolled in the second study on degenerative spondylolisthesis and stenosis. If it had, readers might come away with a more nuanced message about the efficacy of both surgery and nonoperative therapies. (See also “Evidence” above.) For example, the majority of patients receiving nonsurgical care showed “moderate” improvement, a fact the news story never mentioned but the study reported in both absolute and relative estimates. And when the researchers analyzed patients in the randomized cohort according to the treatment they were assigned (“intention-to-treat analysis”), they found no differences in the outcomes of the surgical and nonsurgical care. When they analyzed patients according to the treatment they actually received (“as-treated analysis”), they saw big differences. As the accompanying editorial in the New England Journal of Medicine by Richard A. Deyo points out, the truth probably lies somewhere in between.
The story notes that surgery has risks, but does not explain what the risks are, whether the patients enrolled in the studies were harmed by the treatments they received, or whether other research has documented potential long-term harms not reported in the current studies. For example, fusion eliminates movement in the fused segment of the spine. This not only reduces instability (as intended), but can add extra stress to the segments above and below the fused segment. This added stress often creates its own problems and may trigger additional fusions.
The story does not accurately characterize the nature of the evidence in either of the two studies it reports. The Dutch study on sciatica and disc surgery was a randomized controlled trial. The second study about treatments for people who had degenerative spondylolisthesis (DS) with spinal stenosis compared outcomes in two different cohorts and is more complicated. As in the Dutch study, some 40% of patients in the DS study who were assigned to nonsurgical care changed their minds and had surgery. Though on the surface this might seem like a mere technicality, it is important. Large numbers of “crossovers” in a randomized trial can make it very difficult to estimate the true effect of a treatment—something readers might find helpful to know.
Both spine conditions reported in the news story are real problems for many people. There are no obvious elements of disease-mongering in the story, though its handling of degenerative spondylolisthesis (DS) might lead some readers to conclude that DS is a dire problem requiring surgery, rather than a predicament that might reasonably be treated either surgically or nonsurgically, depending on a patient’s tolerance for risk and preferences. The majority of patients receiving nonsurgical care showed “moderate” improvement, a fact the news story never mentioned. (See also “Evidence” and “Quantification of benefits” below.)
The news story cites two noted authorities on spine care, the lead author of the study on degenerative spondylolisthesis and the physician who wrote the accompanying editorial in the New England Journal of Medicine.
The news story mentions common treatment options for sciatica, but says little about options other than surgery for degenerative spondylolisthesis (DS). In the new DS study, these included epidural injections and physical therapy.
A reader might reasonably conclude that the treatments the story describes are generally available. Whether the same outcomes are equally obtainable at all hospitals is unclear. The studies were performed at some of the leading spine centers in the world.
A reader might reasonably infer that the treatments described in the news story are not new, since the new studies seek to clarify an old question.
The story did not appear to rely solely or largely on a news release.