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FDA approves first computer-based dementia assessment aid; thorough Post report falls just short on key aspects of coverage

Rating

2 Star

FDA approves tool for diagnosing dementia in a doctor’s office

Our Review Summary

There was more to like about this story than its 2-star score might suggest. There is substantial and thorough reporting about the problems with current approaches to diagnosing dementia, and the story demonstrates great legwork in seeking out the opinions of experts who have used the device that’s profiled in the piece. A lot of 2-star stories seem to be thrown together without much original reporting, and that’s certainly not the case here.

With that being said, the story does lack some key information regarding the benefits, costs, and harms of the device. There were also a few borderline calls where we felt that a Satisfactory score couldn’t be given for specific reasons, even though the story came close to meeting our standard. In short, a few small changes would have altered our ratings substantially and resulted in a higher score. But the story is still well worth a read, and delivers plenty of valuable information. We encourage you to explore our comments in the review below to see how we thought the story could have been improved.

 

Why This Matters

As the story rightly points out, dementia is a significant issue that will likely grow in magnitude in the future as the population ages.  The ability to more easily diagnose people in the early stages of dementia would be helpful and welcomed by most clinicians.  Existing methods are time consuming, cumbersome, and their interpretation is complex usually requiring considerable expertise. But there’s an important point to keep in mind: We do not have good treatments for Alzheimer’s and other dementias, and certainly no cures, so even an accurate “early” diagnosis is a mixed blessing and a false positive could do significant harm.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Reporting on any new device, test or drug should include comments about cost.  In this case a word or two about the cost of the device, whether or not it is reimbursable under commercial insurance plans or Medicare would have been helpful.  There is a billing code used for payment by insurance companies and Medicare (CPT 96120: Neuropsychological testing [e.g. Wisconsin Card Sorting Test, CNS Vital Signs], administered by a computer, with qualified health care professional interpretation and report).   The reimbursement for the test and interpretation is $48.

The story did mention that other tests can cost more than $1000, but it’s not clear how much less expensive the new test would be. The story also notes that the test could be administered without the physician present, which might indirectly cut costs and allow time for other important discussions.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The headline suggests that the FDA approved the test for “diagnosing dementia in the doctor’s office.” But the actual FDA approval notice says: “The Computerized Cognitive Assessment Aid is not intended as a stand-alone or adjunctive diagnostic device.” The story does later qualify that the device “is not intended to be a stand-alone diagnostic tool,” but the FDA says the device isn’t a diagnostic device at all, which is a confusing disparity. We acknowledge that reporters often don’t have any control over their headlines but nonetheless the issue needs to be raised. We thought this needed more explanation.

The story suggests that this non invasive, simple and quick (10 minutes sitting at a computer terminal) is either more accurate or just about as accurate as a commonly used test called the Mini Mental State Exam and is easier to use.  The suggestion is supported by comments from the inventor of the test and two primary care physicians.  We are also told that the device/test was applied in a sample of 401 older adults who were classified as cognitively normal, slightly impaired or impaired and compared to the results of another test with the acronym SLUM.  But, we are never provided with any information about the test characteristics that have to do with accuracy (e.g. sensitivity, specificity) or how the two tests compared in the actual study. What were the rates of false positive and false negative results seen with Cognivue as compared to SLUM?

To the article’s credit, it does bring up an important point about how the tool can be incorporated into physician workflow in a way that may make adoption easier (patient does the test right before or after seeing the doctor, for example). That’s useful context, but not enough for Satisfactory rating here.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story mentions that the FDA approved this test on the basis of “little risk.” But we really aren’t told anything about what those risks are. Here’s what the FDA had to say: “The risk of a false positive result may result in result in the clinician conducting a more detailed and extensive medical work-up to determine if a subject actually has cognitive impairment that would not be expected for his/her age and educational level. The risk of a false negative result would also be considered minimal. Clinicians would still be responsible for conducting a diagnostic work-up for patients presenting with cognitive impairment symptoms regardless of the Cognivue device result.”

One thing both the story and FDA neglect to mention is that a false positive can produce patient/family anxiety regarding a devastating condition with no effective treatments. We’re not sure that qualifies as “little.”

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The evidence that the test is useful is limited to the comments of the inventor and two clinicians who have used the test.  We are not provided with any quantitative data to support the anecdotal comments in the story. We assume that the FDA must have examined data as the basis for its approval, but that data isn’t present here.

Does the story commit disease-mongering?

Not Satisfactory

Dementia is a serious public health problem and as the population ages it will become a larger issue.  The story does a good job in providing some useful context.  However we think that the construct of a, “…late-life tsunami of late life cognitive decline coming at us…” and “…Dementia is the gorilla in the corner of the room in every primary care visit with every older adult..” don’t add much in the way of information and suggest that the problem is nearly universal after a given age. Such descriptions are particularly problematic when applied to a cognitive disease that is the source of worry for many and is often conflated with normal behaviors. The company source says doctors haven’t been provided with tools to assess dementia, yet several other tools are mentioned in the piece, including the one that is used as the gold standard comparison for his new test.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

This was a difficult call. The story includes extensive comments from a company source and two clinicians who are early adopters of the device. The comments of the two users especially are quite helpful and demonstrate thorough reporting. With that being said, we hesitate to call any of these sources truly independent. Although the story qualifies that one of the physician users has no ties to the company, the fact that she’s been using the system for several years, presumably with the equipment and support being supplied by the company at no cost, suggests a close relationship between the source and the manufacturer. The intent of this criterion is encourage a truly outside perspective. We think that comments from other sources not as close to the work and who could speak to other diagnostic approaches would have been helpful. The Not Satisfactory rating is not meant to suggest a lack of thoroughness on the part of the story or that the sources provided were not appropriate. It reflects our desire and hope that stories will always also include the perspective of at least one impartial expert.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does a good job in providing the reader with other testing methods and a bit about their complexity and time requirements.  We are told that the new approach is as good if not better that existing instruments.  So, we are giving the story a Satisfactory rating.  But again, we are never given any data supporting that viewpoint.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story notes that the device/test was approved by the FDA and that it is available for use.

Does the story establish the true novelty of the approach?

Satisfactory

The story notes that the device has been approved by the FDA, which counts toward novelty, and it also links to a previous story that discusses other noninvasive exams being tested for early diagnosis of dementia. We’ll award a Satisfactory on that basis, although we think readers might come away from this story thinking that this is the first computerized diagnostic test for the diagnosis of dementia. In reality, there have been multiple attempts at the development of computerized testing including several that are available online.

Does the story appear to rely solely or largely on a news release?

Satisfactory

It’s clear that this story does not rely solely on a news release.

Total Score: 4 of 10 Satisfactory

Comments (1)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Linda Furlini

August 17, 2015 at 9:25 am

This is an important issue. The author should be commended for pointing out no one cognitive test can diagnose Alzheimer’s. However, this article and others like them, fail to indicate that the symptoms of Alzheimer’s and most dementias are unpredictable and variable especially at the beginning of the disease. The disease does not follow a smooth linear progression and tests cannot factor in this fact.

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