This well written blog post accompanied a fairly thorough on-air discussion of two new studies showing the benefits of vaccines for treating middle ear infections in young children.
A child with an ear infection can lead to a frightening and frustrating experience for parents. Because so many doctors are now used to the wait-and-see approach and other doctors are willing to give a child antibiotics just to make the parents happy, studies like this bring clarity to the science behind vaccine recommendations and they empower patients to ask the right questions. This story does a good job translating the consumer message.
Neither the blog post nor the radio piece discussed specific costs, although the blog post did describe the antibiotic in question, Augmentin, as inexpensive. Since these are kids, the suspension would be used (10 days), and the cost according to Drugstore.com is $76.
Because the criteria used in both studies may be substantially more stringent than those used clinically for the diagnosis, the costs of office visits also must be considered.
In addition, the “cost” in the more abstract sense of how much antibiotic resistance “costs” society would have been a great addition to the story.
Neither the blog post nor the radio piece quantified the benefits. The post says, “Both studies, which appear today in the New England Journal of Medicine, find these kids get over painful ear infections faster, and have less severe symptoms, if they get prompt treatment with Augmentin, an inexpensive antibiotic often used to treat respiratory infections.” This is understandable given how confusing the findings are in these articles. But, the story could have made use of one key number that was presented by the authors of the Finnish study: the number needed to treat. “The number needed to treat for 1 child to benefit from antimicrobial therapy, as calculated on the basis of the results of our study, is 3.8, as compared with 7 to 17 on the basis of the meta-analyses.”
The possibility of antibiotic resistance is raised but never quantified in any way. Other harms are not mentioned. This is a significant omission. Both studies list adverse events, and the Finnish study saw a large number of children with adverse events. As the authors note, “An adverse event occurred in 85 children (52.8%) in the amoxicillin–clavulanate group and in 57 children (36.1%) in the placebo group (an increase of 16.7 percentage points with amoxicillin–clavulanate”. Of those who received the drug, 77 had diarrhea, 17 had vomiting and 14 had eczema. There also are harms from not taking the drugs, which were not mentioned.
The blog post did not discuss the study’s design or say much about the evidence, but the accompanying radio story did. It said that the studies involved more than 600 kids with infections and that half were given immediate antibiotics and half were given a placebo. It would have been nice to know that these were “randomized, double-blind, placebo-controlled” studies, as the journal articles note. This would have distinguished them from what the writer calls “a slew of studies over the past couple of decades indicating that most children with ear infections get better without antibiotics.” As the study from Finland notes, “Several guidelines for the management of acute otitis media recommend an observation period before antimicrobial therapy is even considered. These recommendations are based largely on meta-analyses that concluded that for 1 child to have relief of symptoms, 7 to 17 children must be treated with antimicrobial agents. However, some experts have suggested that the original studies included in the meta-analyses had important limitations, such as biases in patient selection, varying diagnostic criteria, and suboptimal spectrum or dosage of antimicrobial agents.” This is important context that would be helpful for readers in sorting out the importance of the findings.
The story does not engage in disease-mongering. In fact, we wish it had spent a little more time explaining whether the only reason to give a child antibiotics was because of the pain and whether the infections ever spread or seriously threatened a child’s health.
The story does a great job using independent experts who provided a reasoned, thoughtful discussion of the findings. The one omission was the failure in the blog post or the radio piece to report that two of the authors on the US study had received funding from the drug company that makes the antibiotic being studied: GlaxoSmithKline. However, the drug is available as a generic product (especially the suspension used in kids) and the NIAID funded the study, so we’ll give the story the benefit of the doubt on this criterion.
By talking with the experts, such as Dr. Jerome Klein of Boston University and Dr. David Spiro of Oregon Health Sciences, the blog post does a great job comparing the wait-and-see approach with the antibiotic approach. It also notes that the American Academy of Pediatrics endorses the wait and see approach and specifically speaks to the issue of correct diagnosis. We would have liked to have seen some definition of wait and see. And we wish the story had provided more data to back up some of the assertions made by the doctors.
The story made it clear that the “wait and see” approach to ear infections is widely recommended. The accompanying radio piece reported that there are “13 million prescriptions every year for ear infections,” in part because only about 20% of doctors actually follow that approach.
Both the blog post and the radio piece explained why these studies might start changing the way clinicians behave and might give parents more information for helping them demand the right kind of treatment. “Much of the confusion, experts say, has been caused by studies that weren’t careful enough about the diagnosis. If many children in prior studies didn’t really have ear infections, then it’s not surprising the antibiotics didn’t work for them, says Dr. Jerome Klein of Boston University, who wrote an editorial that accompanies the new studies.”
The story does not rely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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