New pathway to the heart

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no discussion of costs. With an approach that is this early in its development, we probably can’t expect an accurate price tag on this particular device. Nevertheless, to provide some context, the story could have easily offered information about the cost of similar neurostimulation devices used to treat pain and urinary incontinence. 

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

Not Satisfactory

The story frames the research through the experience of Mr. Hollis Bardwell, the first patient in the study to have a neurostimulation device implanted. The story tells us Mr. Bardwell is "looking forward to rocking and rolling again" — an optimistic outlook that will no doubt serve him well as a patient. But as readers, we want to and deserve to know whether Mr. Bardwell’s enthusiasm is justified, and unfortunately this story doesn’t provide a balanced perspective. As discussed above, the objectives of this phase 1 study are modest and include mostly safety-related assessments. And even if the study does report dramatic benefits for the device on heart function, we won’t know until larger studies are performed whether the results are broadly applicable to other patients with heart failure. By focusing on the experience of one patient and failing to mention the many hurdles that that lie ahead in the development of this device, the story paints an unacceptably rosy portrait of the technology.

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

Not Satisfactory

No potential harms were mentioned — unacceptable when the whole point of the study being covered is to ensure the safety of the new device. Known complications of implanted neurostimulation devices include wound infections at the surgery site and breakdown of the device or hardware requiring reoperation. Since these devices have never been studied in advanced heart failure patients, we don’t know if these issues might cause more serious problems in these patients than they do in healthier populations where neurostimulation has been tried before.

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

Not Satisfactory

The story makes it clear that this approach is just beginning to be tested, so there isn’t much evidence to evaluate. But it should have done a better job of explaining why researchers think this approach might work. At one point, the story says there is "considerable data" showing connections between the brain, nervous system and heart, but it doesn’t elaborate or describe this research at all. Elsewhere the story says "the hope" is that neurostimulation will modulate nervous system responses to beneficial effect. But is there any evidence that this might happen — for example from animal studies or from patients with other conditions treated via neurostimulation? Summarizing some of this research would have helped explain the basis for the current study.

Another problem: the story doesn’t provide an adequate account of how the study will be performed and what it will assess. This is a missed opportunity to emphasize the modest aims of small phase I studies, which are primarily about ensuring safety. The story says that the researchers will be conducting tests on patients fitted with the new device "to measure heart function." But according to a description of the study at clinicaltrials.gov, the study will first and foremost be looking at indicators of safety such as hospitalizations, episodes of arrhythmia, and deaths. Discussing these aims in more detail would have provided better context for understanding the research.  

Does the story commit disease-mongering?

Not Satisfactory

The patient profiled in the story is clearly in the most advanced stage of heart failure and may have a dire outlook, but there are many effective and life prolonging therapies for earlier stages and not all patients reach his stage. In addition, it is misleading to suggest that most patients end up on 7 drugs that are ineffective; there are many lifestyle, dietary, and drug treatments that are known to be effective for heart failure. This patient anecdote – coupled with phrases such as "prognosis is grave" and "usually ultimately fatal" – may mislead readers.

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

Not Satisfactory

The story includes interviews with one of the study researchers and a patient, but it should have tapped someone with no links to the research for an independent take. We’ll flag this one as unsatisfactory.   

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

Not Satisfactory

Although the story is clear that this treatment is in the early stages of development, It doesn’t give readers a very good sense as to when it might be available to the general public. Paraphrasing one of the researchers, the story states that it "likely will take about a month before doctors have a good idea whether the therapy is working," which might suggest to some readers that it might soon be available after that. Yet this is a phase I study which is primarily geared to assess safety. It is not until Phase II and III studies are completed and successful that companies will go for FDA device approval. This could take many years and the research may never come to fruition. The story never explained this.

Does the story establish the true novelty of the approach?

Not Satisfactory

The approach being discussed is, indeed, innovative, but we think it’s a stretch to state categorically, as this story did, that "no one" has attempted to take therapeutic advantage of the relationship between the brain, nervous system, and heart before. Research for example has long described a link between depression and heart risks, and some investigators have tried to exploit this knowledge previously by offering psychotherapy or antidepressant therapy to patients with heart disease. There’s also some question about whether this research team is in fact the first to implant a neurostimulation device for treatment of heart failure; a press release issued on July 29 claims another team studying this issue had already enrolled its first patient. Regardless of who was first, the story could have mentioned that other researchers are actively investigating this area.