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Read Original Story

Surgical procedure urged for atrial fibrillation

Rating

3 Star

Surgical procedure urged for atrial fibrillation

Our Review Summary

This article on catheter ablation, a treatment for atrial fibrillation (AF), is marred by three flaws:

  • It fails to disclose that Johnson & Johnson, maker of the device being tested, sponsored the study. In fact, nearly all the researchers have deep entanglements with device makers; two of them work for the maker itself.
  • The story fails to point out that the studied participants represent a subset of younger patients who are not representative of typical AF patients.
  • It reports the study’s duration was one year. It was nine months.


Having said that, for the most part the story is well-done: It accurately describes the procedure. It portrays the benefits appropriately and indicates potential harms. It notes the need for longer-term studies to ensure the treatment prevents death and strokes over time.

The errors in the story do not result in misrepresentation, and readers will take away the fundamentally correct message: When drugs fail to treat atrial fibrillation, ablation works far better at reducing symptoms and AF occurence than a second drug regimen.

They may believe incorrectly that the results apply to typical AF patients, who are older.

The nine-month vs. one-year mixup seems forgiveable–as merely sloppy or rushed.

But without the sponsorship disclosure readers miss any hint of the commercial hustle behind the study and research into similar devices generally. 

As a matter of fact, that theme would have been nicely enhanced with another detail the story omits: the cost of the device the sponsor sells. 

 

Why This Matters

Atrial fibrillation is a common condition that can lead to stroke, other serious cardiac problems, and death. Frequently, drugs fail to treat the condition successfully; the drugs also have cumulative side effects. A better second-line treatment that controls irregular heartbeat could prevent many strokes, improve quality of life–and save lives.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not cite costs of either the surgery or the drug treatment it is compared to. At a time when medical costs are so much in the public mind, stating treatment costs is important.

When a study is sponsored by a device maker, it is all the more important to disclose costs.

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

Not Satisfactory

The story does a solid job quantifying the difference between the two patient groups in the study, clearly showing the superiority of ablation in reducing symptoms and AF occurence.

But the story makes a blunder: The study reported results for nine months, not one year as the article states. For this reason the story receives an unsatisfactory rating.

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

Satisfactory

The story cites the most significant risks of the surgery: stroke, and damage to the veins or esophagus. It is a bit jarring, however, to learn that the surgery carries a 1 percent risk of stroke only in the last paragraph. 

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

Satisfactory

The story is based on a randomized clinical trial; its size, duration and outcomes are adequately described.

The study’s key limitations–its one-year duration and its inability to speak to the surgery’s effect on the endpoints of death or stroke–are duly noted as caveats.

The limitation the reporter misses–that the study group doesn’t represent the typical AF patient–is significant but not serious enough to earn the story an unsatisfactory rating.

Does the story commit disease-mongering?

Satisfactory

The story does not exaggerate the prevelance or severity of atrial fibrillation.

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

Not Satisfactory

The story quotes three sources–the study’s lead author and two independent cardiologists.

While this is normally adequate, all of the doctors support ablation. It would have been invaluable to speak with a cardiologist who is neutral on the procedure. This interview would likely have surfaced some of the study’s methodological limitations.

More seriously, the story fails to disclose that Johnson & Johnson, maker of a device used in the surgery, sponsored the study. Many researchers have entanglements with the sponsor and other device makers. This is a serious omission.

Does the story compare the new approach with existing alternatives?

Satisfactory

Like the study, the story compares catheter ablation to the second-line drug therapies used when a primary drug treatment is ineffective.

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

Not Satisfactory

It’s not clear whether catheter ablation is available only at highly specialized cardiac care centers or at most hospitals. It’s also not clear how widely practiced it is.

Does the story establish the true novelty of the approach?

Satisfactory

The story makes no claims for the novelty of catheter ablation. It would have been useful to know how long it has been in use, however.

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

Satisfactory

The story uses independent sourcing and does not draw from the press release.

Total Score: 6 of 10 Satisfactory

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