Our Review Summary
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This news release describes how researchers are adapting a test they developed for rapid diagnosis of prion diseases to earlier detection of Parkinson’s disease and dementia with Lewy bodies. The news release gives data from the results, which appeared in a published study, and explains how a more rapid test could help identify patients for clinical trials. However, it doesn’t talk about the impact of early detection of these devastating diseases on patients or give a good sense of the test’s potential availability. Also, it doesn’t mention that four of the authors have applied for a patent on the related technology.
Why This Matters
Quicker, cheaper detection of neurological diseases might be good for individual patients, or it might not. News releases about such advances will be read by patients and their families and should strive to discuss the impact of early diagnosis, beyond the potential benefits for research. That might include prompter treatment of symptoms or unnecessary anxiety, for example.
Readers should be aware that since the test is still under development; earlier detection from such a test isn’t going to be available to individual patients any time soon.
Criteria
Not Satisfactory
There’s no mention of the cost. The study itself says having quicker results “markedly enhances the cost effectiveness and practicality” of these tests.
Satisfactory
The release says the test “correctly excluded all the 31 controls and diagnosed both Parkinson’s disease and dementia with Lewy bodies with 93 percent accuracy.” The author also noted the number of people tested.
Not Satisfactory
There’s no discussion of how patients might be affected by earlier diagnosis. For example, do patients want to know whether they have one of these incurable diseases?
According to the study, “the earlier the diagnosis, the earlier that any appropriately targeted therapies can be initiated before further tissue damage is done.” But the news release doesn’t explore that potential benefit.
Also, a 93 percent accuracy rate means 7 percent of patients will get a false result. According to the study, the test correctly identified those without the disease in all cases, which means the disease was not detected in some patients, which could give them a false assurance.
The release doesn’t assess potential harms of taking spinal fluid samples, which though generally considered safe it is still an invasive test and can result in headache, back pain, bleeding, and increased skull pressure. The release states that researchers are attempting to come up with better tests for neurological diseases “using the least invasive patient sample possible — whether that is blood, skin, nasal brushings, or other samples.”
Satisfactory
The release gives specific information on the scope of the study, including that researchers “tested 60 cerebral spinal fluid samples, including 12 from people with Parkinson’s disease, 17 from people with dementia with Lewy bodies, and 31 controls, including 16 of whom had Alzheimer’s disease.”
However, it doesn’t mention some limitations, such as very small number of patient volunteers and the researchers’ observations that factors such as sample volume and temperature “strongly influenced the performance of the assay.” The researchers say further testing will be necessary to understand some of the specific detection abilities of the test, including when they’re used in clinical settings.
If the test is to be used in clinical trials, standardization across sites will have to be assured — both where samples are collected and where the assay is done.
Satisfactory
There’s no evidence of disease-mongering. The release says Parkinson’s disease affects “up to 1 million people in the United States, with 60,000 new cases diagnosed each year. Lewy body dementia affects an estimated 1.4 million people in the United States, according to the Lewy Body Dementia Association.”
Not Satisfactory
The news release mentions that the research was supported by the NIH but doesn’t mention other significant funders such as the Parkinson’s and Movement Disorder Foundation and the Shiley-Marcos Alzheimer’s Disease Research Center at the University of California San Diego.
It also doesn’t note (as the published article does) that four study authors have applied for a US provisional patent application on the technology.
Satisfactory
The news release says “test results were available within two days, compared to related assays that require up to 13 days.”
However, it doesn’t say how the faster test compares in terms of accuracy. The study says early detection is helpful in part because “the accuracy of diagnoses based on other clinical indices is poorest in the earlier phases of disease.”
Not Satisfactory
The tentative wording of the lead — that the test could “offer the possibility of improving early diagnosis” — raises the question of what needs to happen for this test to become widely available. The release doesn’t answer that question.
Nor does the study discuss improved diagnosis since that’s not the intent of the test’s development — it’s research to determine who to include in trials and follow their disease progression.
Satisfactory
The release does a good job here, stating:
Early and accurate diagnoses of these brain disorders is essential for developing treatments and identifying patients eligible for clinical trials. The diseases typically progress for years before symptoms appear, and once they do, distinguishing one disease from another can be difficult.
Satisfactory
There’s no unjustifiable language.
Total Score: 6 of 10 Satisfactory
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