The news release focuses on new software that, it claims, could expedite the ability of health care providers to identify cause of stroke and the site of whatever is causing the stroke. This, in turn, could then allow health care providers to provide treatment more quickly, which would improve patient outcomes. However, the release leaves out virtually all of the study’s key details regarding the technology. What hardware is required to go with the software? Has it been tested in humans? How much does it cost? Does it require special training? Is it publicly available? If not, when might it become available? The release addresses none of these questions.
According to the CDC, stroke is responsible for approximately one out of every 20 deaths in the United States each year. And rapid response is crucial to patient outcomes. As the Mayo Clinic notes: “A stroke is a medical emergency. Prompt treatment is crucial. Early action can minimize brain damage and potential complications.”
Most strokes are due to blockages in blood flow to parts of the brain that cause cell death unless blood flow is restored. Treatment of acute stroke focuses on quickly identifying the underlying cause of the stroke and then implementing therapies. Traditionally, identifying the cause, such as a blood clot, a narrowing of the blood vessel or a broken blood vessel that is causing bleeding into the brain, is accomplished using a CT brain scan. If a blood clot is suspected, then therapies may include clot busting medicines with or without attempts to remove the clot itself.
This study focuses on efforts to more quickly identify patients for blood clot removal. The goal is to bypass the standard CT scan and do it in the place where the procedure to remove the clot is done. But before new diagnostic techniques such as this one become routine, a lot more work needs to be done. The authors of this study focus on speeding up the time to performing the blood clot removal, but it is unclear if this is intended to be in place of clot busting medicines or not. If meant to replace clot busting medicines for most patients, then future studies will need to show whether this alternative initial treatment is better than getting a standard CT scan and giving a clot busting medicine. This is a very preliminary step in a longer process to identify new and effective ways to manage patients presenting with stroke in whom the cause may be one of several possibilities.
New technologies that can improve response time, and improve patient outcomes, are of widespread interest. We can understand why an institution would be excited about announcing discoveries in this field, but it is important to do so responsibly. That makes the failure to address even basic questions about the new software problematic.
Costs are not addressed, either of this form of CT imaging compared to standard, or to the overall cost of care for acute stroke management. Nor does the release outline any factors that may influence potential cost. Is software the only thing new here? Or is new hardware also needed? This part is confusing. The release tells readers that the relevant study is titled “New Multiple CT Assessment of Acute Stroke Patients: Are We Ready for Prime Time?” This indicates that the software relies on CT scans. The release further states that “recent advances in imaging software in the angiosuite give neurointerventionalists the essential details required to diagnose a patient [with a particular type of stroke]. This study suggests that in the future, stroke patients can bypass the CT scan…” But, if they are bypassing the CT scan, what images is the software working with?
Benefits are not quantified. The release says only that the new software “could decrease delays in care…giving patients a better chance at making a full recovery.” In addition, it’s not clear here if improved response times are purely hypothetical, or if they are based on some sort of study.
The release provides no direct information on how the new test results compared to the standard version. Moreover, the study was not intended to see whether outcomes were improved as a result of this new test because it was added to the standard assessment. As a result, it may have actually delayed care for patients included in the study.
Harms aren’t discussed. Are there potential risks associated with using the new software? The release doesn’t say one way or the other. As noted previously, the study involved adding the new technology to standard care. So it may have actually harmed study patients. More broadly, the study was not designed to assess the relative benefits/harms of this new technique compared to the current standard.
The closest the release comes to mentioning evidence of any kind is a reference to “preliminary results.” Are those results based on computational models? Pre-clinical testing in laboratory animals? Early results from a phase 1 clinical trial? The release doesn’t tell us. Almost no information is provided on what actually happened to patients enrolled in the study.
No disease mongering here. Minimizing the consequences of acute stroke is an important health topic. It would have been helpful if the release had included some context about the prevalence of stroke or how many patients might potentially be candidates for the new technology.
The release does not tell readers who funded the research, who developed the software, or whether there are any conflicts of interest among the researchers.
The release briefly discusses alternatives in this sentence: “Preliminary results show that the cone beam imaging software compares favorably with baseline and follow-up CT scans.” It would have been helpful to note if the software compared favorably in terms of speed, accuracy, or both. What sort of testing was done? What were the results? How does that compare with baseline and follow-up CT scans?
The release also says that “This study suggests that in the future, stroke patients can bypass the CT scan or emergency department and go directly to the angiosuite for imaging and proper care.” Thus the comparison is mentioned but it could have been made clearer. It also could have noted that medicine-based treatment (clot busting drugs) is an alternative to the procedure described here.
It is not clear if this software is already on the market or if it is in the early stages of development. Given that the study, which was presented at a conference, is subtitled “Are We Ready for Prime Time?” this is an issue that the researchers were planning to address — but no hint of that information is in the release.
It’s clear that this is a new technique, but the parts fitting the novelty bill could have been better described. The software appears to be what’s new here.
The title of the release is unjustified. There is nothing in the study that supports the claim that this technology reduces brain damage. At best one can say it could lead to faster treatment. Whether that would be better or not requires future research.