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Heart Score: New Treatment for Heart Failure
February 16, 2009
The plural of anecdote is not data. Viewers were told one very positive patient story, but nothing about whether that's a representative outcome. No independent sources. Nothing on harms or costs.
Our Review Summary
The piece presents a new invasive technology that is undergoing current research for congestive heart failure. But it did so by profiling a dramatic improvement in one individual patient. The procedure itself is described as requiring a 1.25 inch incision that could be done in an hour and which resulted in the benefit of losing 40 pounds and the ability to walk 4.5 minutes longer on a treadmill in this particular patient. How representative is that outcome? What type of patient is the ideal candidate? Does the story want us to think that all 5 million Americans with congestive heart failure are candidates? Why didn’t the story provide any data from the trials that have been done to give some indication of the quality of the evidence for both benefits and harms. The story of the terrific outcome in the one patient may raise the hopes for some patients who may not live near one of the 29 trial centers or who may result in others entering the trial with unrealistic expectations.
Click on Criteria for definitions.
It was clear from the conversation that this device is not FDA approved and is available in the US only as part of an ongoing clinical trial.
Our rule of thumb: if it's not too early to talk about how "exciting" and "fascinating" this is, then it's not too early to project how much it will cost patients.
Leading the segment with the claim that 5 million Americans have congestive heart failure could leave the impression that's the potential market for this device. And nothing in the piece attempted to counter that impression.
The segment did not provide insight about the type of patient for whom this sort of device might be a consideration. It also did not provide a context for understanding the model of the enlarged heart such as whether it is this the case in all individuals with heart failure? or whether it is something that can be reversed?
Lastly - the comment from the anchor "Right. It's just impossible to continue on with life as this heart gets bigger and bigger and bigger...." is not a helpful framework for reasoned conversation.
The segment failed to mention where in the clinical trial proccees this device is currently at. (From www.clinicaltrials.gov, it appears that there are phase II and phase III testing currently underway.) In addition, the segment did not provide viewers with information about how success with the device is defined and how often it is successful. It should have been possible to report on the outcomes from the phase I study and from its use outside of the US.
There was no mention of any harms that might be associated with the use of this device.
The segment appropriately reported about the novelty of treating heart failure with the Heartnet.
The only quantification of benefit given was the story of one patient. Anecdotal information is an inadequate presentation of treatment benefits. The plural of anecdote is not data.
Because this segment was an interview with a doctor and patient, it does not seem to rely on a press release. However - at http://www.newswise.com/articles/view/536804/ , one finds that "Dr. Maybaum and patients will be available for interviews".
No independent source was interviewed.
If CBS can demonstrate that they came up with this segment based on their own enterprise reporting, we'll be happy to change this score.
The only sources of information for this segment were the clinician and patient. There were no comments from independent clinicians with expertise in heart failure to comment about this device.
There was no discussion about the options currently available for the treatment and management of heart failure, other than brief mention of heart transplant.
Total Score: 2 of 10 Satisfactory
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