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Nonsurgical treatment for infants with ear deformities: Release doesn’t disclose conflicts of interest

Nonsurgical treatment can correct congenital ear malformations in infants

Our Review Summary

Infant ear, before and after. Image: Becon Medical website

The news release focuses on a recent journal article that evaluates the use of a nonsurgical treatment called the “EarWell system” to treat malformations of the ear in newborn infants. The news release reports that results were judged “good to excellent” for most patients in the retrospective study. However, the release poses some significant problems for readers. For example, the release doesn’t discuss cost and does not tell readers that the study co-author quoted extensively is the inventor of the EarWell system. The release also treats ear deformation and ear malformation interchangeably — a distinction made clearly in the relevant journal article. This is particularly important because the numbers discussed in the news release sometimes refer to patients with deformities and sometimes to patients with malformation.

 

Why This Matters

Ear malformations and ear deformations are not the same thing. As the journal article itself makes clear, “deformations are characterized by a misshapen but fully developed pinna [or external portion of the ear] with no missing skin or cartilage,” whereas “malformations demonstrate a partial absence of skin and/or cartilage resulting in an underdeveloped pinna from an error in embryologic development.” The headline, section headline and first three paragraphs all refer solely to malformations. Deformity is mentioned for the first time in paragraph four, and in such a way as to make many (if not most) readers assume the terms deformity and malformation are interchangeable. But they’re not interchangeable.

Here’s one reason that matters: the release later tells readers that “results were judged good to excellent in 97 percent of ears with one simple deformity.” And, based on the journal article, that’s true. But it wasn’t true for ear malformations — which is what the headline and opening paragraphs would lead readers to expect. Parents of newborn infants want to do what’s best for their children, and having to make medical decisions for their infants is a stressful and emotional ordeal. Those decisions can be particularly tricky when the medical decision to be treated is not life threatening. Confusing news releases do not help people make informed decisions under any circumstances, but that is particularly true in circumstances as fraught as those facing parents of a newborn.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release does not address cost at all, which is particularly unusual given that the release focuses on the use of a product that is already on the market. Given that online cost estimates for the EarWell system range from $2,500 to $4,500 per ear, this is a significant oversight.

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

Not Satisfactory

This is not satisfactory for several reasons. First, as noted above, the release does not tell readers that there is a difference between an ear deformity and malformation of the ear. As a result, it would be very easy for readers to assume that the benefits for patients with ear deformities would apply to patients with ear malformation. There are some other problems as well. Here’s some of the language from the release: “Results were judged good to excellent in 97 percent of ears with one simple deformity and 88 percent with more complex ‘mixed’ deformities. About 70 percent of ears with constricted malformations were graded as having no deformity after treatment.” Here are the problems: What does it mean that results were “good to excellent”? What is the difference between “simple” and “mixed” deformities? How are those different from “constricted malformations”? And how many patients were in each group? Percentages can be misleading if any of the listed subgroups were particularly large or small. Benefits should be clearly explained and quantified, and that wasn’t the case here.

We aren’t told what proportion of the less severe deformations would have spontaneously improved. The study and news release claim a high rate of success but it’s not clear what this should be compared to. It’s possible that some reasonable proportion of such ears do OK without intervention.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release clearly addresses the vast majority of the complications discussed in the journal article, which is enough to earn it a satisfactory rating. However, the release does not mention the possibility of infection. There was only one case identified in the article, but it is also the most significant of the complications that cropped up over the course of the (retrospective) study.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release does not explicitly state this was a retrospective study, rather than a clinical trial, but it implies as much when it says “The researchers review their experience with nonsurgical correction of congenital ear malformations in 175 infants.” However, there’s a problem with that sentence: the researchers didn’t treat ear malformations in 175 infants. The researchers also didn’t treat a total of 303 ears, as the release states. According to the article itself, the researchers treated 478 ears in 201 patients. Specifically, the researchers treated 303 newborn ear deformities in 111 patients, and 175 infant ear malformations in 90 patients. In short, while we give the news release a pass for suggesting (rather than clearly stating) that this was a retrospective study, the description of the study in the release is fundamentally wrong.

Does the news release commit disease-mongering?

Not Satisfactory

This is a close one. The release begins by stating that EarWell can help infants “avoid the pain and cost of later surgery.” That’s problematic, given that people aren’t required to undergo a later surgery — it’s purely elective. However, the release later makes clear that these treatment options are designed to address issues related to “teasing, bullying and loss of self-esteem” that could stem from ear deformity or malformation. And those are very real concerns that parents do take into consideration. That makes it a bit of a toss-up. What tipped it into the disease mongering camp was the section heading that states “Nonsurgical Treatment Avoids Later Consequences of Infant Ear Malformations.” What could this mean? Hearing loss? Higher rates of ear infections? Something worse? Eight paragraphs later, the release mentions the “teasing, bullying and loss of self-esteem” as noted above. Those are important things for parents to consider, but they are certainly not a foregone conclusion. And scaremongering language in the section heading, and the huge gap between the section heading and the description of the “consequences” go too far.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release refers to study co-author H. Steve Byrd four times, but never mentions that he has a financial interest in EarWell systems. In fact, as the journal article states: “Dr. Byrd has a royalty agreement with Becon Medical [which markets EarWell] for his work designing the EarWell device.” And Byrd isn’t the only one. Another of the co-authors is also listed in the journal article as having an investment in Becon Medical. This sort of conflict-of-interest information needs to be disclosed in a news release.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release cites an independent source, stating “While we can operate on ears later in the patient’s life, waiting not only increases the surgery’s difficulty and expense, but may expose the child to teasing, bullying, and loss of self-esteem.” We’re giving the benefit of the doubt here since the release suggests delayed surgery as an alternative treatment. It would have been better if the release had mentioned no treatment — or watch and wait to see if less severe ear deformities resolved on their own — as an option as well.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release makes clear that the EarWell system is not new and is already in clinical use.

Does the news release establish the true novelty of the approach?

Satisfactory

The release notes that: “While the EarWell system is not new, the report is the largest study of congenital ear malformations treated with this approach–including a standardized approach to treatment and assessment of the results.” That earns it a satisfactory rating here. However, the release would have been much stronger if it had offered some information as to how these study findings related to previous evaluations of the EarWell system. Are they consistent with previous results? And if they diverge from those results, how so?

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We’ve already dinged the release for problems with language under the section on disease mongering. We don’t want to penalize them twice for the same thing, so it earns a satisfactory rating here.

Total Score: 5 of 10 Satisfactory

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