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Read Original Story

Device’s trial run gets high praise

Rating

2 Star

Device’s trial run gets high praise

Our Review Summary

There’s nothing inherently wrong with a local newspaper story that lets readers know about local medical centers participating in a multi-center trial.

But what can be wrong with such a story was seen in this story.  It failed to: 

  • provide any data on harms or benefits
  • go beyond a single positive anecdote of patient success
  • offer any independent perspective, interviewing only a single conflicted source
  • include any estimate of costs of this approach which could be considerable.

There must be a big promotional campaign underway for this device, since the substance of this story – and the timing of it – is very similar to one we reviewed on NBC just a few weeks ago.

This is not the way journalism should cover new medical devices.  What kind of an environment does such unquestioning storytelling create for public discussion and understanding of medical technology assessment and comparative effectiveness research? Journalism can help the public understand more about scrutinizing evidence, about potential harms and about costs.  These factors were sorely missing in this story. 

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story didn’t mention any of the costs of treatment involved – not the known nor projected costs of the device, of its implantation, of followup care, nor of battery replacement.

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

Not Satisfactory

No data – no evidence – was provided.

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

Not Satisfactory

The story mentioned the need for periodic battery replacement, but didn’t describe what that entails.  Is it another operation?

The story quotes one researcher saying "We ask that (patients) don’t lift more than 10 pounds for a month."  Why?  What happens if they do?  What’s the track record of complications? 

The one patient profiled said she had swelling in her neck after the surgery.  How often does that happen? How often do any complications occur with this device?  

The story was silent on quantifying the frequency or severity of the potential harms of this approach.

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

Not Satisfactory

The story presented no evidence – only anecdotes – yet it let one of the investigators get away with saying "It’s only with this device that (patients are) able to bring their blood pressure under control."  Where are the data to back that up?

Does the story commit disease-mongering?

Satisfactory

There was no overt disease-mongering of the condition of difficult-to-control high blood pressure.

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

Not Satisfactory

Interviewing only the principal investigator of a trial, who has a vested interest in a successful outcome – without including the perspective of any independent expert – is not sufficient sourcing.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Drug therapy for the control of hypertension was mentioned in the story but the emphasis was on the side effects of medications.  Yet the story didn’t give sufficient details about the side effects of the device implantation or its operation. So there was an imbalance in the discussion of treatment options.  There was also no discussion of other medical devices currently being investigated for the purpose of controlling blood pressure or lifestyle factors that affect blood pressure and cardiovascular risk.

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

Satisfactory

The story made it clear that the device is being tested "at up to 50 clinical sites worldwide" and listed the two local medical centers participating in the trial.

Does the story establish the true novelty of the approach?

Not Applicable

There wasn’t any explicit discussion of the novelty of this approach, so this criterion is not applicable in this case.

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

Not Applicable

We can’t be sure of the extent to which the story may have been influenced by a news release.  An Iowa Heart Center news release had this line:

The Rheos® Hypertension Therapy System™ is a high blood pressure treatment which consists of an implantable device designed to electrically activate the body’s own natural blood pressure regulation system in order to treat drug resistant hypertension.

The story had this line:  

 The Rheos system is a high blood pressure treatment that is being tested for use in drug-resistant cases. It consists of an implantable device that electrically activates the body’s own natural blood pressure regulation system. 

Suspicious, but not evidence of total reliance on a news release.  

Total Score: 2 of 8 Satisfactory

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