Researchers develop test for pregnancy complication
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Researchers develop test for pregnancy complication
Our Review Summary
This story took preliminary research on a diagnostic test for a common and urgent pregnancy complication—preeclampsia—and made the research appear to be a life-saving medical breakthrough. In the study, an international group of researchers reported identifying a “metabolic signature”—a group of 14 biomarkers in the blood of pregnant women—that might aid in the diagnosis of preeclampsia in its early stages. The diagnostic test, like any complex diagnostic technology, faces years of research development and clinical trials. The article offered a best-case scenario for the development of this test. It did not provide a single cautionary note to balance out this hopeful view. The main question that goes unanswered in this story is whether a diagnostic test that was studied in 120 women and then validated in 79 pregnant women in Australia will be equally valuable for millions of women around the world. Will it turn into a test that can be administered simply and interpreted easily? Could it be just as useful in Mali, Cambodia, or Micronesia as it might be in developed nations? Will the test have adequate predictive value—both positive and negative—in a wide range of ethnic groups and among women with differing health problems? Only time and further research will tell. If this test lives up the diagnostic potential envisioned in the Reuters story, it would be a major step forward indeed. But the story should have provided more independent experts to give a more balanced view of the evidence that supports it. The Reuters article closed with an optimistic quote from Eleni Tsigas, Executive Director of the Preeclampsia Foundation, on the potential of this test to identify women at risk. But perhaps the article should have included another quote from Tsigas that appeared in a Canadian newspaper: “I am not going to be breaking out the champagne yet…” (See Wingrove J, Globe and Mail, September 13, 2010).
Why This Matters
Preeclampsia is a common but poorly understood pregnancy complication characterized by dangerously high blood pressure and elevated levels of protein in the urine. It affects up to 8% of pregnancies worldwide, with a particularly damaging impact in developing nations. In the United States preeclampsia is the root cause of 18% of maternal deaths. For babies born prematurely because of maternal preeclampsia, it is an important precursor of developmental abnormalities. The identification of a diagnostic test for preeclampsia has been termed the "Holy Grail of obstetrics." If preeclampsia could be recognized early in pregnancy, it might be possible to ward off some of its potentially serious consequences through vigilant surveillance of mother and baby. And identification of early changes that precede preeclampsia might boost research efforts into finding more effective treatments.
Criteria
Not Satisfactory
Costs are not mentioned in this story. This is partially excusable because the diagnostic test is still under development, but, given the possibility of applying this test in low-resource settings, it would have been important for the reporter to ask the researchers for a cost range to show whether it is going to make any sense for most of the world. Many tests like this are too expensive to be applied widely, and there would be comparable tests that could be mentioned as a cost comparison.
Not Satisfactory
The story says that the study "identified 40 organic molecules to be significantly elevated and 5 that were reduced in plasma at 14 to 16 weeks’ gestation," quoting the study. It would have been nice to have some context for those numbers. Is elevation bad? Is reduction good? The numbers just float and don’t add to our understanding. The story goes on to say, "From this series of compounds they narrowed down a list of 14 sugars, fats and amino acids that were different in the women who developed the condition. It detected around 90 percent of the cases, with a false positive rate of about 24 percent, meaning 24 percent of the women flagged in the test as having a risk of pre-eclampsia would never actually develop it." Given that the sample size is so small, the story should have provided the numbers both in percentages and in absolute terms. That 90 percent figure sounds huge, but we are still only talking about 71 women. And, of those, 17 were false positives. Those numbers would have been good context for helping readers understand the findings. The study itself is actually fairly easy to understand.
Not Satisfactory
The preliminary nature of the research makes it difficult to accurately assess potential risks associated with the diagnostic test. At the same time, high in the story the lead author touts the huge potential benefits of the research. "Such a "metabolic fingerprint" test could save the lives of thousands of women, Philip Baker of the University of Alberta in Canada, who helped lead the study, said in a statement." With all screenings and "early warning sign" tests there are opportunities for overtreatment and potentially harmful treatment, this should have been addressed in some fashion. For example, the main treatment right now for preeclampsia is magnesium sulfate. As the Preeclampsia Foundation, which is quoted in this story, points out on its website, "Nevertheless, magnesium sulfate, is not a benign drug and must be used by a skilled health care provider with appropriate support facilities. Overdoses can and do occur."
Not Satisfactory
The author did not convey clearly the preliminary nature of the evidence on this diagnostic test and did not present the study in an accurate context.
Satisfactory
There is little evidence of disease mongering in the article. Preeclampsia is a serious and potentially lethal condition for both mother and child, and that is made clear.
Satisfactory
The article did include a comment from Eleni Tsigas, executive director of the Preeclampsia Foundation. A better source would have been another researcher, perhaps one of the many cited in the article. The article did not mention whether any of the researchers had conflicts of interest regarding the development of the diagnostic test. The study itself says the authors had no disclosures and reports the study to be entirely government funded. Given that at least one outside source was contacted and that there were no obvious conflicts to disclose, we give this one a pass.
Satisfactory
The article made it clear there are no validated diagnostic tests for preeclampsia early in pregnancy.
Satisfactory
This is an experimental diagnostic test and not available beyond research settings. The story makes that clear.
Satisfactory
The article makes it clear that this is a novel diagnostic test.
Not Satisfactory
The article appeared to draw from the journal’s press release and on the press release from the University of Alberta. But there is enough original reporting here to make it squeak by.
Total Score: 5 of 10 Satisfactory
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