The news release concerns a very small (12 human subjects) preliminary trial to assess if a swallowable capsule can measure intestinal hydrogen gas as well as the existing method of breath testing. Such breath testing is used to aid in the diagnosis of a small handful of uncommon gastrointestinal disorders.
What’s problematic here is the lack of supporting data from the study, as well as overreaching claims that the test “beats breath test diagosis” and is “3,000 times more accurate than current technology.” This kind of hyperbolic language is not supported by the study.
Harms also are not mentioned and benefits are framed in such a way that erroneously suggest the technology will help “diagnose many gut disorders … paving the way to solving previously undiagnosed conditions.”
On the plus side, we were encouraged to see that the financial conflicts of interest of at least one of the two main study authors were made clear.
It’s not uncommon for us to come across early results of studies involving a small number of human subjects being presented with grandiose clinical implications. Such language is a red flag and, as with this news release, sometimes comes from the very people we’re counting on to accurately interpret the data for us — the lead authors.
If you’re going to employ language like “revolutionary” and “breakthrough” in reference to study involving 12 healthy subjects, at the very least include data. Likewise, explain to people what you mean when you say something is “3,000 times more accurate” than current technology. While this test might be able to detect much smaller concentrations of gas than existing methods, the researchers certainly haven’t established that this makes any difference in the ability to diagnose disease — and that’s something that should have been clearly pointed out to readers.
The news release makes many bold claims about the accuracy and clinical utility of this device. And if it’s not too early to make such claims, it’s not too early to give readers some idea of what this type of technology might cost.
The main benefits touted are:
Unfortunately, we’re not given any supporting data, or context to place these results in perspective.
Are readers expected to know what high sensitivity and signal-to-noise ratio are?
We’re told the capsule measures gases, but how do those relate to disease?
Furthermore, where exactly did the “3000 times more accurate” figure come from and what does it mean? Based on our analysis of the study itself, it seems that the capsule detected about 12 times as much hydrogen as the breath test in the point of the intestine with the greatest difference.
And “sensitivity” (the ability to correctly identify patients with disease) cannot be measured since there are no patients with confirmed disease in this study. (We provide an overview of sensitivity and other issues related to medical testing in our primer: Understanding medical tests: sensitivity, specificity, and positive predictive value.)
The published study mentions “no reported adverse events,” but the news release does not address harms.
Harms are relevant since we’re guessing many readers might be wary of swallowing an electronic transmitter and hope “this too shall pass” (without incident).
Another harm that isn’t mentioned is the risk of false-positive findings that may lead to unnecessary antibiotic treatment for some people. Such treatment poses risks to individual patients and contributes to the growing problem of antibiotic resistance.
This news release doesn’t include any data.
Yet it includes claims about the test’s ability to diagnose diseases, even though the study was only a pilot that included healthy individuals.
There’s a disconnect between the strength of the evidence and the language used in the news release.
The news release makes it sound like there is an epidemic of undiagnosed gastrointestinal disease occurring worldwide:
Of the one-in-five people worldwide who will suffer from a gastrointestinal disorder in their lifetime, almost a third remain undiagnosed due to lack of reliable tests available to gastroenterologists.
But the news release doesn’t provide any source for this questionable claim.
Moreover, the release suggests that that this technology will help “diagnose many gut disorders” when, in reality — even if it does get marketed (like breath testing) — it will likely only be applicable for a very short list of very uncommon gastrointestinal ailments listed HERE [Source: Johns Hopkins Medical School].
It’s made clear that one of the sources quoted is the capsule co-inventor, and is also the chief technology officer of the company trying to commercialize the capsule.
However, it’s unclear if the second source — identified as the study lead and a capsule co-inventor — is also affiliated with the company.
The news release makes it clear that the capsule is being developed as (hopefully) a more sensitive measure of intestinal gases than currently used breath tests. It’s also made clear such testing is used to diagnose conditions like small intestinal bacterial overgrowth (SIBO) and carbohydrate malabsorption.
It’s implied the capsule is in development and not commercially available at this time.
It’s unclear from the news release if this is the first time this sort of capsule has been used for this particular purpose.
However, this article from MIT suggests swallowable technology has been investigated since at least 2006.
The use of the words “breakthrough” and “revolutionary” is quite premature in referring to trial results of 12 healthy subjects.
Also, inclusion of this quote by the study lead is potentially very misleading:
This gives us confidence that our new technology could potentially solve many mysteries of the gut and help the large portion of the population who have not been able to find a useful diagnosis or treatment for their symptoms.