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It’s never OK to use ‘groundbreaking treatment for strokes’ when it’s never been tested in people

Rating

4 Star

Categories

Exclusive: Doctors to Test a Groundbreaking Treatment for Strokes

Our Review Summary

surgery, Medical InstrumentThis story explains that researchers at the Cleveland Clinic are searching for a first patient for a trial testing whether deep brain stimulation (DBS) might be helpful in improving the outcome of physical therapy in disabled stroke patients.

It provides little solid evidence that such a procedure would lead to a positive clinical outcome.  Nevertheless, the story suggests that this serious invasive brain surgery might work and the headline describes it as potentially “groundbreaking.” The story also overlooks that the costs per patient would seem prohibitive for the volume of people who might seek it out.

Later in the story, things get a little less breathless: We find out there are harms associated with this surgery, including some that might not yet be known.

 

Why This Matters

As this Time Magazine story points out, around 800,000 Americans suffer strokes each year and half of those are disabled by these events.  A procedure that might improve their quality of life would be a boon to public health.  DBS carries significant risks, is expensive, and this story provides little evidence to support its enthusiastic claims.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

While this story admittedly is announcing a new procedure never tried in human stroke patients, it conveniently glosses over the sheer complexity of what is being proposed–intricate brain surgery for stroke patients–a procedure that inevitably will cost tens of thousands of dollars, and that if successful will actually only be an adjunct to aid in subsequent physical therapy following a stroke.  Given that the story says that annually, nearly half of stroke patients will be disabled — 400,000 — the cost of using this procedure on even a portion of those represents a staggering public health cost.

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

Not Applicable

Human trials have not yet begun.  The story discusses rat research:

“But for 10 years, Machado and his team have been studying the effects of DBS on rats. They found that rats with strokes who received DBS had more proteins in the brain that are associated with brain plasticity—and twice as many synapses or connections between nerve cells compared to rats with strokes who did not undergo DBS.”

But no data were provided to explain what “more proteins” means – how much more? In how many of the rats?  What is the significance of twice as many synapses?  So the discussion of the animal research is almost meaningless.

Nonetheless, we’ll grade this Not Applicable since it’s clear there are no human data to report. However, this does raise the question of why this pre-trial announcement is newsworthy in a national news outlet.

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

Satisfactory

Near the end, the story does mention that “DBS is a type of brain surgery, and comes with risks like bleeding, infection and need for more surgeries” so it earns a Satisfactory rating. It also points out some harms may be unknown. But we would have been happier if the risks were not buried in the last paragraph of the story by which point, odds are, some people would have stopped reading.

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

Not Satisfactory

While the story is raising the hopes of stroke patients, it actually provides little evidence that the proposed procedure will work or be “groundbreaking” as the headline states. It mentions that DBS has been effective with some Parkinson’s disease patients in eliminating some symptoms of that illness. But it only suggests that in earlier studies in rats, DBS was associated with an increase in proteins in the brain associated with plasticity, meaning that it might be facilitating the brain’s ability to repair stoke damage.  The earlier animal studies found DBS was associated with many more nerve synapses, suggesting improved communication between nerve cells.  But neither of these findings necessarily mean an improved clinical outcome for patients, which is the hope actually raised by the story.

The leap from animal research to humans–or from use in people with other conditions–is not emphasized strongly enough.

Does the story commit disease-mongering?

Satisfactory

There is no disease-mongering of stroke in the story.

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

Not Satisfactory

The story only quotes a single source–the head of the clinical trial who will also be the person leading the DBS surgery. There is no discussion about potential conflicts of interest.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does point out that the standard treatment for stroke victims who suffer a disability is physical therapy. However, clot busting drugs and other early intervention methods are also being tried as means to improve stroke outcomes.

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

Satisfactory

This story is pretty clear that actual clinical application of DBS for stroke patients is a long way off, given that the first patient on which this will be tried hasn’t been identified yet.  So we’ll rate this a marginally Satisfactory, with the caveat that stories like this which raise patient hopes prematurely can do real harm to people and their families. We would have liked it better if the story had spelled out how many steps it will take before this becomes an actual treatment (if ever).

Does the story establish the true novelty of the approach?

Satisfactory

The novelty of the investigation of deep brain stimulation for stroke patients is made clear.

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

Satisfactory

There is no indication that this story relied on a news release.  A quick check of the Cleveland Clinic’s website shows no release touting this research project.

Total Score: 6 of 9 Satisfactory

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