This story is chock full of testimonials praising an asthma treatment that uses radio waves to zap troublesome lung tissue. Readers would never guess that the editorial author who commented on the key trial of the device wrote that “The overall net effect of bronchial thermoplasty in the AIR2 trial is somewhat disappointing.” Indeed, based on the only double-blinded, randomized controlled trial of the device, almost all of the improvement reported by patients could be explained by a placebo effect, something the story doesn’t mention.
The story does a commendable job on many of our criteria, but then it stumbles on the fundamental question of how much of an advance the new treatment really is. It also fails to alert readers to financial ties between researchers and the company now marketing a bronchial thermoplasty device.
When someone says a new treatment is better, it is imperative to ask, “Better than what?” By failing to tell readers that most of the people in the control group also improved during the key test of this asthma treatment device, this story paints an overly rosy view. By our calculation, the number needed to treat with this approach is 7 – you’d need to treat 7 people in order for one to benefit. Wouldn’t that have been helpful information?
The story is concise but thorough. In three sentences it reports that few insurers cover the procedure because it is new, that the cost ranges from $12-18,000 and also that some patients with severe asthma may spend a similar amount on standard care (including hospitalizations.)
As noted in the comments on the quality of the evidence, this story left out essential information about the key published trial data of bronchial thermoplasty. While the story includes several patients telling how much better they feel after treatment, it fails to tell readers that most of the patients in the control group also reported feeling much better after undergoing sham treatment. As the editorial accompanying the journal article on the trial noted, it is crucial to include a comparison with a control group when assessing the overall benefit of this sort of intervention. The story fails to give readers that important context.
The story reports that the treated patients were less likely than control group participants to have an asthma attack, go to an ER, or lose work or school days. But not only does the story leave out the absolute improvements, it fails to inform readers that when adverse events related to the treatment itself are included, there was no net benefit seen over the first year.
Oddly, the story leaves out any mention of the primary outcome measure of the key trial: what the patients reported on a standard questionnaire about their asthma-related quality of life. The story should have pointed out that while about four out of five people treated with bronchial thermoplasty reported clinically significant improvement, almost two out of three people given the sham treatment reported similar improvement. Based on the results reported by researchers, about seven asthma patients would have to be treated in order to get one additional person who says he or she has a significantly better quality of life. The story includes only glowing reports from treated patients and thus gives readers a flawed view of the potential benefits.
The story does warn of risks. However, it doesn’t tell readers how common they are. In fact, the researchers reported that 85 percent of patients reported at least one adverse event and that problems (including hospitalizations) occurred often enough in the first few weeks after treatment that it was only when researchers disregarded those treatment-related problems that they saw a net benefit during the first year. The researchers say their longer-term follow-up indicates patients report ongoing benefits according to some of the research measurements, but the story should have pointed out that the potential gains come only after enduring several weeks of recovery and elevated risk.
This is where the story gets tripped up.
When the trial results were published in the American Journal of Respiratory and Critical Care Medicine, an accompanying editorial not only called the results “somewhat disappointing,” it questioned the lack of information about biological basis for the treatment effect. The editorial also highlighted an important trial result that was left out of this story: most of the participants in the control group reported feeling better after receiving sham treatment. The story should have alerted readers to the powerful placebo effect, which makes the anecdotal reports in the story highly suspect. Indeed, if the reporter had interviewed people who got the sham treatment, most of them would have also reported that they were faring much better a year after their “treatment.”
References:
Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma. American Journal of Respiratory and Critical Care Medicine. 2010 Jan 15;181(2):116-24. Epub 2009 Oct 8.
Abstract: http://www.ncbi.nlm.nih.gov/pubmed/19815809
Full text: http://ajrccm.atsjournals.org/cgi/content/full/181/2/116
(subscription may be required)
Editorial:
Bronchial Thermoplasty: Has the Promise Been Met?
American Journal of Respiratory and Critical Care Medicine Vol 181. pp. 101-102, (2010)
Elisabeth H. Bel, M.D., Ph.D.
http://ajrccm.atsjournals.org/cgi/content/citation/181/2/101
(subscription may be required)
The story includes an estimate from the device manufacturer that about 10 percent of people with asthma might be candidates for this procedure – those who have problems controlling their asthma despite trying all standard treatments. It also specifically says that bronchial thermoplasty is not for people with mild, occasional asthma.
However, the story closes with a quote saying that doctors will start using the treatment on more patients once they have more experience with it. Will that expanded use be based on evidence or anecdote? Journalists should keep an eye out for practitioners and marketing that encourage people with milder cases of asthma to have this treatment and check to see if there are new clinical trial results to justify the broader use.
It’s hard to tell whether an independent source is included. There is no doubt that the story fails to inform readers about the financial ties between most of the quoted experts and the company that funded their research and is now marketing the bronchial thermoplasty device. The conflict of interest statement included with the journal article on the key trial is more than a thousand words long, detailing payments from companies, including Asthmatix, the maker of this device (now part of Boston Scientific), to the lead researchers.
The story does disclose that the company provided the contact information for all of the patients quoted in the story. It does not say whether any of the control group participants who got the sham treatment were contacted.
The story does refer to standard treatments; however, it portrays standard treatment as often inadequate for the type of patient featured in the story. The editorial accompanying the key research article on this treatment says that the fact that most of the control group participants in the trial reported doing better while they were in the trial may indicate that they had not been getting optimal standard treatment beforehand. The editorial author says bronchial thermoplasty should not be considered unless a patient has first been “submitted to a rigorous treatment protocol.” In other words, when people with asthma say that standard treatment isn’t working, the real problem may be that they haven’t actually been treated properly.
The story notes that the FDA approved this asthma treatment earlier this year and that it is available at about 30 medical centers in the U.S.
Bronchial thermoplasty is indeed a relatively new approach to treating asthma. However, almost all of the trial results reported in this story were announced more than a year ago. The news is that the researchers recently presented results from the second year of follow-up at a medical meeting. However, the new information was barely mentioned in the story.
The story does not appear to be based on a news release. However, all of the patients quoted in the story were provided by the device manufacturer. Technically, we must give the story a satisfactory score on this criterion since there is no evidence it relied solely or largely on a news release, even though it violates the spirit of the criterion.
Systematic, Criteria-Driven
More for milk debates: "Switching to skim #milk may slow biological aging" https://upi.com/6975065t via @upi cc @garyschwitzer @joansalgeblake
"We can't say that this was caused by milk fat." As is often the case with nutrition studies: correlation ≠ causation.
#RelaxDammit
@HealthNewsRevu @mcjaklevic HealthNewsReview once again revealing hype that far outstrips reality. I suspect that one day, AI will meaningfully contribute to good patient care. Whether that's in 10 years or 100, I couldn't say. What is clear is that we ain't there yet.
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