Efficiency versus effectiveness: impact of molecular testing on healthcare costs and clinical outcome of patients with indeterminate thyroid nodules
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The value of the Afirma gene expression classifier for the differential diagnosis of cytologically indeterminate thyroid nodules has been extensively debated since the publication of the initial clinical data in 2012. In a recent meta-analysis, Santhanam et al.  reported a pooled specificity of 30.5 % and a pooled sensitivity of 95.7 %. The statistical analysis was based on clinical data from seven peer-reviewed studies that met widely accepted quality criteria for bias and applicability. This work is important because it provides prevailing estimates of test performance and utility to better inform clinical decision making. The authors concluded that the updated performance of the Afirma test “makes it an excellent tool to rule out malignancy”. I believe this statement is only partially correct; a test with a specificity of 30 % might not be an effective diagnostic procedure, both clinically and economically.
The performance metrics that define the effectiveness of a molecular test...
KeywordsThyroid Cancer Thyroid Nodule Molecular Test Benign Nodule Health Economics Study
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Conflict of interest
EL was an employee of Asuragen Inc. from March 2006 to March 2014 and a consultant for PDI Inc. from September 2014 to October 2015. The author does not have any direct or indirect employment for and does not hold any equity interest in companies providing commercial testing services for thyroid nodules.
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