This evening news segment on new evidence showing some back surgeries aren’t effective does a very good job on many levels. It:
Given all this, one is tempted to give the segment a pass for its omissions, such as a failure to mention that the studies’ size and brevity prevent them from being conclusive and that the placebo may have had some effect that non-treatment in a clinical context would not. But two omissions are harder to overlook:
It’s true that both of these issues fall outside the findings of the studies. But so does the material about health care costs and evidence-based medicine. Some mention, at least brief, should have been made of the risks of surgery and the questions about non-surgical treatment. This would have provided a clearer picture of the findings’ implications.
As good as the segment was, it could have also helped viewers think about some important take-home questions:
This highlights what health care reform needs to do to address saving costs on expensive low return interventions.
The segment reports the procedure costs $2,000 to $5,000.
The reporter gets extra points for putting these costs in the context of larger concerns over health care spending on procedures that are not proven effective.
The segment makes only a very general statement about results: "there was no difference up to six months later for patients who actually had the procedure and those who had a fake or placebo treatment instead."
But this echoes the un-nuanced language of the conclusions stated in the abstracts. One says the improvements for the groups "were similar" and the other says the surgeries "had no beneficial effect."
The segment also made clear that patients in both groups saw improvement rather than no change, a useful observation about the benefits.
The segment therefore minimally earns a "satisfactory" rating despite its lack of detail.
Given the fact that the studies suggests the surgery has no benefits, the segment should have mentioned its risks.
Vertebroplasty is considered very safe. But it carries some risks: cement leakage into nearby tissues and the possibility [though data are inconclusive] of increasing the risk of fracture in other vertebrae. There are small risks of soft-tissue damage and nerve-root pain and compression.
Like all surgeries, vertebroplasty carries risks of bleeding, infection and anesthesia, which are higher for the elderly population than the general population.
The segment is based on results of two studies published in the New England Journal of Medicine. The studies are of very high quality: single-blinded, randomized, placebo-controlled, multi-center clinical trials.
While both studies are relatively small (131 and 78 patients), the conclusions are strengthened by the fact that they produced similar findings.
Ideally, the segment would have stated that the studies followed patients for no more than six months, leaving the question of benefits [or risks] over the longer term unanswered.
It’s also worth noting that the placebo was not a fake injection of the cement but a short-acting anesthetic, which may have had an effect on the condition that non-treatment would not.
On balance, the segment earns a satisfactory rating.
The story does nothing to exaggerate the prevalence or severity of the conditions that vertebroplasty is used to treat.
The producers earn extra points for using three well-selected sources:
The segment earns even more bonus points for using an anecdote involving someone who got the placebo procedure and still felt the surgery benefited her–a rare case when a personal story makes a point other than the usual, "Well, the treatment worked for me."
Major flaw here: The segment fails to look at non-surgical treatments for painful osteoporotic fractures that, by inference, should be more widely considered.
This is an important issue.
Patients who get this surgery are usually in considerable pain. Quality of life is reduced. While the studies suggest placebo treatment works as well as surgery, this is of little consolation to someone with a painful, disabling condition who needs relief.
Standard non-surgical treatment for painful osteoporotic fractures doesn’t work in some severe cases and carries its own risks.
Treatment usually includes use of pain relievers, including some narcotics, which can cause gastrointestinal problems, poor balance and the risk of addiction. Other pain meds are poorly tolerated in an older population.
Bed rest carries its own risks for older people with osteoporosis, including physical deterioration.
Physical therapy is often beneficial, but compliance can be low and hard to sustain.
Finally, without successful treatment, the condition can lead to joint problems, spine misalignment, impaired gait and balance, muscle spasms and falls.
The segment reports that about 40,000 vertebroplasties are done each year, implying wide availability.
The segment clearly illustrates that the procedure is not novel–and the fact that it is so widely done makes the findings relevant to the larger issue of health-care costs.
Several press releases were issued about this story, but this report does not appear to draw on them.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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