This release focuses on a small study that was trying to determine whether a new method for sequencing blood samples might be a way of identifying people with cerebral palsy (CP) earlier than the methods used now.
The work centers on the early findings of differences in methylation sequences in the DNA that might point out patients with the disease. The proposed method of genetic testing is still comparatively expensive and the release makes no mention of costs. The release gives very little numerical data on the outcomes of the research and neglects to address the harm that might arise from false negatives and false positives, even though the release points out the diagnostic accuracy was only 73% in a pilot study involving younger children. This means at least one in four results were wrong. The release applies the term “breakthrough” in its headline, when it clearly is no such thing, and states unequivocally in the lead that the test works, although it is far too early to make such claims.
Cerebral palsy is a devastating condition both for patients and their families. Patients are currently diagnosed as toddlers when they begin developing motor problems. There is currently no diagnostic test that can identify patients at earlier ages. The annual health care costs for a patient with CP, according to the release, is “10 to 26 times higher than for those without CP,” making this a costly public health problem. If a blood test were available to identify patients soon after birth, it may allow for earlier intervention and ultimately, better outcomes. But the work explained by the release is much too preliminary to lay claim to that solution.
Although earlier detection of CP would almost certainly drive more interventions/consultations, it is less clear that these interventions would actually lead to better outcomes. If the findings are so subtle that they are not evident on exam or by developmental milestones in early life, then it is not clear that an intervention (aggressive PT or early surgery, as suggested in the “pull out quote” in the news release) would be beneficial. Therefore, it is possible that “early detection” would simply increase costs, and possibly, parental anxiety, in the long run.
There is no mention of the cost of this proposed diagnostic approach anywhere in the release. The entire approach to the claims made in this release relies on next generation sequencing of blood samples which can run into hundreds and sometimes thousands of dollars. The research paper points out that the approach relies on the use of parallel computing facilities, a highly expensive capability for many medical centers.
The release does provide the following statement: “The researchers identified a strong set of methylation markers, or patterns, that indicate differences in the genome between children with spastic CP and those without it. In a second study, using samples from children aged 2-5 years, the researchers were able to validate their results and predict with 73 percent accuracy whether the blood samples came from children who had CP.” What the release doesn’t say is that the study only involved 16 subjects with cerebral palsy and 16 controls — an extremely small sample.
There is no mention of potential harms that might arise from the use of such a test. A blood draw is a low risk procedure; the real potential harm comes from over- or under-diagnosis and that should have been clarified.
The so-called “evidence” provided by this release is largely circumstantial in that it relies on the idenfification of different methylation patterns found in the DNA of cerebral palsy patients compared to those who don’t have the disease. There is no evidence to determine if the methylation patterns led to the development of the disease or that the disease caused the change in patterns. The sample size in this study is way too small to support the optimism of the source statements in the release, and certainly the headline’s suggestion that the study is a “breakthrough” in cerebal palsy diagnosis is a vast exaggeration. Lastly, in the second study cited in the release, it mentions a 73 percent success rate in differentiating between blood samples from CP patients and those of controls, which means that just over one in four of those samples was wrong.
The release doesn’t engage in disease mongering.
The release names the various funding sources for this work and is clear in pointing out the commercial role, and potential economic benefit, to some of the authors.
The release mentions that currently, cerebral palsy patients are identified “by monitoring motor milestones.” It says also that there is currently no blood test available to identify CP patients younger that about two years old.
This was a small pilot study and the release states, “Many issues will need to be addressed, but we predict routine screening for CP in the near (<10 years) future.” While many may differ with whether the “near future” is define by “fewer than 10 years,” the release gets credit for spelling this out.
The release is clear in saying that there is no established diagnostic blood test for identifying cerebral palsy patients.
The release is premature in claiming the test is a “breakthrough” in the headline. The lead, stating “that DNA patterns in circulating blood cells can be used to help identify spastic cerebral palsy (CP) patients” is also too absolute given the nature of the research findings.
This release focuses on a small study (22 children with spastic cerebral palsy and 21 controls) that examined whether a new method for sequencing blood samples might be a way of identifying people with cerebral palsy (CP) earlier than the methods used now.
The work centers on the early findings of differences in methylation sequences in the DNA that might point out patients with the disease. The proposed method of genetic testing is still comparatively expensive and the release makes no mention of costs. The release gives very little numerical data on the outcomes of the research and neglects to address the harm that might arise from false negatives and false positives, even though the release points out the diagnostic accuracy was only 73% in a pilot study involving younger children. This means at least one in four results were wrong. The release applies the term “breakthrough” in its headline, when it clearly is no such thing, and states unequivocally in the lead that the test works, although it is far too early to make such claims.
Cerebral palsy is a devastating condition both for patients and their families. Patients are currently diagnosed as toddlers when they begin developing motor problems. There is currently no diagnostic test that can identify patients at earlier ages. The annual health care costs for a patient with CP, according to the release, is “10 to 26 times higher than for those without CP,” making this a costly public health problem. If a blood test were available to identify patients soon after birth, it may allow for earlier intervention and ultimately, better outcomes. But the work explained by the release is much too preliminary to lay claim to that solution.
Although earlier detection of CP would almost certainly drive more interventions/consultations, it is less clear that these interventions would actually lead to better outcomes. If the findings are so subtle that they are not evident on exam or by developmental milestones in early life, then it is not clear that an intervention (aggressive PT or early surgery, as suggested in the “pull out quote” in the news release) would be beneficial. Therefore, it is possible that “early detection” would simply increase costs, and possibly, parental anxiety, in the long run.
There is no mention of the cost of this proposed diagnostic approach anywhere in the release. The entire approach to the claims made in this release relies on next generation sequencing of blood samples which can run into hundreds and sometimes thousands of dollars. The research paper points out that the approach relies on the use of parallel computing facilities, a highly expensive capability for many medical centers.
The release doesn’t provide much numerical context to tell us how this test would benefit patients. It does state that the test predicted with 73% accuracy whether a blood sample came from a child with CP. This phrasing could be misleading to readers since 73% accuracy means that just over one-in-four of the samples was wrong.
There is no mention of potential harms that might arise from the use of such a test. A blood draw is a low risk procedure; the real potential harm comes from over- or under-diagnosis and that should have been clarified.
The release doesn’t tell us how many samples were analyzed in the studies. It also relies on “a strong set of methylation markers, or patterns, that indicate differences in the genome between children with spastic CP and those without it” as an indication of the likelihood of CP. It doesn’t offer readers any details on what the differences were between children with CP and controls, or how they were measured.
The release doesn’t engage in disease mongering. It provides some context about the disease, including its prevalence.
The release names the various funding sources for this work and is clear in pointing out the commercial role, and potential economic benefit, to some of the authors.
The release mentions that currently, cerebral palsy patients are identified “by monitoring motor milestones.” It says also that there is currently no blood test available to identify CP patients younger that about two years old.
This was a small pilot study and the release states, “Many issues will need to be addressed, but we predict routine screening for CP in the near (<10 years) future.” While many may differ with whether the “near future” is define by “fewer than 10 years,” the release gets credit for spelling this out.
The release states there is no established diagnostic blood test for identifying cerebral palsy patients but it’s too early to claim that this test, still under development, is the novel “game changer” to fill that need.
The release is premature in claiming the test is a “breakthrough” in the sub-headline and a “game changer” in the lead researcher’s quote.
Systematic, Criteria-Driven
For breakfast, @GarySchwitzer swallows 2 observational studies with an anti-irritant chaser. https://www.healthnewsreview.org/2020/06/for-breakfast-give-me-2-observational-studies-and-an-anti-irritant/#.XvtqMk8i5e8.twitter
Sitting & cancer...alcohol & improved cognition. Waking up to a double whammy of miscommunicated observational studies.
https://www.healthnewsreview.org/2020/06/for-breakfast-give-me-2-observational-studies-and-an-anti-irritant/
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like