Our Review Summary
But we wish it had given even a little context of what’s done to help predict prematurity now instead of the vague quote from the researcher saying “the test ‘should be an important tool for an obstetrician who currently has no clue’ if premature birth is a possibility until it happens. …Physicians will ‘be able to use a simple blood test and then know that this woman is at increased risk or reduced risk of a preterm birth.’ ”
As the story later made clear, this research is a long way away from being able to prove that claim.
Why This Matters
Most of our criteria were addressed in this story, yet more context and more independent expert perspective focusing on the data reported in the study would have been helpful. The most challenging fact – which wasn’t addressed – is that we lack interventions to use at and after 28 weeks that effectively prevent preterm birth.
Criteria
Satisfactory
The story included an estimate that “The test may cost $150 to $250.”
Satisfactory
Mixed bag here. We’ll give it a somewhat satisfactory grade. Here’s why.
The story stated that the test “predicted 80 percent to 90 percent of the premature births at 28 weeks of gestation. The false positive rate — referring to tests that wrongly indicated premature birth — was 20 percent. The test wasn’t as effective at 24 weeks of gestation.” It didn’t give any numbers to back up the experience at 24 weeks.
But we would have appreciated somewhere a note that it is the very early preterm births that are the most crucial to predict. The story fixates on 28 week testing. What’s really needed are means to identify and study the 23 to 28 weekers. The story also doesn’t acknowledge that we have no effective interventions to stop preterm birth and somewhat incorrectly explains how betamethasone for lung maturity works.
It also had an independent expert’s quote: “If you are going to be alarming a patient by saying that she may have premature delivery, you want to make sure that’s truly the case.” That’s a very important contribution to the story.
Satisfactory
It mentioned that the false positive rate was 20%, so we’ll give it a passing grade. We wish, though, that it had included some expert comment on the significance of a false positive rate that high.
Satisfactory
We’ll give it a satisfactory score, but because very high in the story it stated that “The test isn’t ready for prime time, however, and it’s not foolproof: a study found that it misses some premature births and incorrectly predicts others.”
Satisfactory
The story gave estimates of how many births are premature, so did not commit overt disease-mongering.
Satisfactory
The story quoted one independent expert; it could have been improved with more comment from her or from others.
Not Satisfactory
The story didn’t comment on any other research in this field – nothing on any other investigations into what can be done to better predict prematurity. So this one study on this one approach is reported in isolation.
The big gap that is unaddressed is that we don’t have any treatments even if we know someone is at high risk. In effect, we would be “alarming” lots of patients to no particular end at this point; unless they have had a prior preterm birth and are eligible for progesterone treatment but use of that preventive intervention starts at 16 to 22 weeks and is not relevant to the new test.
Satisfactory
It’s clear from the story that “It would require several years to go through the U.S. Food and Drug Administration approval process.”
Not Satisfactory
The story never put the new test into the context of other research attempts to study what to do to predict prematurity. So its real novelty – and role – isn’t clearly established.
Satisfactory
It’s clear that the story did not rely solely on a news release.
Total Score: 8 of 10 Satisfactory
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