Our Review Summary
We would have liked to see more independent assessment of the specific results presented at this scientifiic meeting. Ideally, the story should have touched on the limitations of drawing conclusions from results presented at scientific meetings – results that have not been peer-reviewed.
Why This Matters
A validated non-invasive test for lung cancer could offer several benefits. The current protocol to diagnose lung cancer frequently includes an X-ray and then a biopsy or other invasive procedure to investigate any X-ray abnormalities, which are common. But X-rays have a high rate of false-positives: 20% or more of those invasive investigations reveal that the abnormality is benign. CT scans may improve specificity, but there have been concerns about the radiation levels in these scans. Thus, a new diagnostic method, if specific and reliable enough, could be an important advance used to confirm abnormalities seen on x-ray before undergoing biopsy, with the potential to reduce patient discomfort, complications, and costs.
Criteria
Not Applicable
Costs are not discussed, as this is an investigational procedure.
Satisfactory
The article provides n values and quantifies the results from the first stage of the study. The potential benefits of the test have to do with its ability to rule out malignancy based on X-ray results; thus, the specificity and sensitivity data are particularly relevant.
We wish the paragraph on subjects with stage I disease would have quantified the results. It provides no sensitivity or specificity rates to justify the conclusion of the technique’s potential application in early stage disease.
Not Applicable
Quantified harms are not as pertinent since this a blood test. However, one could infer indirect harms, the false positives and false negatives, from the data provided.
Not Satisfactory
The story is up-front about these results being preliminary and from a conference. Ideally, the story should have further described the preliminary nature of these findings, in a way that would have made sense to a lay audience. The results have not been peer-reviewed, and the technique is only being developed based on these data. In other words, the study didn’t assess a technique, they built one to match the data. The strategy hasn’t been tested in a realistic population.
As this report was all about a new diagnostic test, is it particularly important to define the groups clearly and the sensitivity/ specificity (and positive predictive value/ negative predictive value).
This is where independent expert assessment of these results would have helped clarify their significance and early status.
Regarding SomaDX, mentioned offhand, this evidence and its 90% sensitivity isn’t evaluated at all. At the time of this article, the report hadn’t even been officially released by the company, and not independently vetted.
Satisfactory
The article does not exaggerate the burden of lung cancer, accurately citing ACS statistics and the enormous importance of the disease. It also does not overstate the problem of false positives.
Satisfactory
An independent source was cited, a meeting attendant, and the SomaLogic quotes were added for context. The latter were good for illustrating that the Dubinett group is not the only game in town working on this type of blood test.
Ideally, the article would have had more independent analysis of the specific results. No independent source was used to assess the SomaLogic employee’s claims of their experimental test’s sensitivity. Although the MedPage Today coverage of the study is aimed at a professional medical audience, it provides a good example of some of the critical points outside sources can provide about these type of very early results.
Although the article does not identify conflicts of interest, from the MedPage Today article it’s not clear that the investigators disclosed any conflicts of interest in their abstract.
Satisfactory
The article describes the challenges with existing techniques, proceeding to invasive procedures following X-rays, and the outside source mentions CT scans.
Satisfactory
The story acknowledges that the results are preliminary and the test is [in the best-case scenario] a few years away from being clinically available. The investigator’s quote that "It might take three or four more years before these tests are clinically available" assumes the test will be proven valuable in trials, which is a premature claim. Availability is not inevitable.
Satisfactory
The story suggests that there is no clinically useful blood test to diagnose lung cancer currently available, and it implies the novelty of this test when it states that it builds on previous research. It also mentions that several other investigators are currently looking into blood tests for early-stage lung cancer.
Satisfactory
The article does not appear to rely solely or largely on a news release.
Total Score: 7 of 8 Satisfactory
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