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How solid is the evidence for an implantable sleep apnea device? NBC’s story doesn’t say

Rating

3 Star

Categories

New Technology May Help Ease Sleep Apnea

Our Review Summary

This story looks at a relatively new implantable device for sleep apnea. While it mentions costs of the device and includes a common side effect, for the most part, it’s unbalanced.

While glossing over the details of the scientific evidence needed to support such this treatment, we get no sense of how the implantable electric-current delivering device actually works, how many people it was tested on, and how it compares to other effective ways to treat sleep apnea.

 

Why This Matters

This story, while somewhat informative about the problem of sleep apnea, casts an overly positive glow on the surgically implanted device. In reality, the evidence for this invasive, expensive device is rather weak.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

We learn: “The price tag for the Inspire device is $20,000, with surgery costing extra. Insurance companies are reviewing requests on a case-by-case basis.”

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

We learn that a “clinical trial of Inspire therapy found a 78 percent reduction in the number of sleep apnea events per hour for patients.”  78% reduction–compared to what? And how does that compare to the CPAP machine?

The story also creates a false sense of equivalence between the large body of evidence behind CPAP machines and the small uncontrolled pilot studies on the new device.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story says the main side effect from the device is “that people can wake up with a sore tongue.” We’ll give this a barely passing satisfactory. (What about people who may have suffered adverse reactions or complications from surgery?)

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The evidence underpinning this implantable technology should have a fairly high bar, given that it is invasive, expensive, and there are already a range of effective ways to treat sleep apnea that helps many people. There is, however, no information about how reliable the assertions of this new technology are and the details on the quality of evidence expressed in this story is minimal. From what we can tell, there are a handful of studies on this new device.

Does the story commit disease-mongering?

Satisfactory

There is no overt disease mongering here. But we’d like to know where the “90% are undiagnosed” figure comes from since this could contribute to disease mongering.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story does not disclose that the one study it relies upon as evidence for Inspire’s effectiveness was funded by the drug company.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

We are only told that the usual alternative–an external continuous positive airway pressure (CPAP) machine–“proved too cumbersome” for this one patient’s continued use. Also, according to a NEJM study, we are told that CPAP machines don’t “help prevent heart attacks or stroke, although it does help patients sleep better and improve mood.” How does the implantable device fare in terms of heart attacks or stroke? The story doesn’t tell us.

Bottom line: There is much more evidence showing CPAP is proven to improve the very same outcomes for which the new device is touted. This point should have been included.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

We learn that the implantable pacemaker-like device was “approved by the Food and Drug Administration in 2014.” This is sufficient, but it would have been helpful to know what types of doctors do the procedures and how widely it’s offered.

Does the story establish the true novelty of the approach?

Not Satisfactory

We know that there are a number of “remote-controlled” internal devices already on the market so what makes this one novel is open to question yet not clearly answered in the story.

Does the story appear to rely solely or largely on a news release?

Not Applicable

We could not locate a news release.

Total Score: 4 of 9 Satisfactory

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