1. Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study.
- Author
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Santos MT, Rodrigues BM, Shizukuda S, Oliveira AF, Oliveira M, Figueiredo DLA, Melo GM, Silva RA, Fainstein C, Dos Reis GF, Corbo R, Ramos HE, Camacho CP, Vaisman F, and Vaisman M
- Subjects
- Brazil, Humans, Prospective Studies, Retrospective Studies, Decision Support Systems, Clinical, MicroRNAs genetics, Thyroid Neoplasms diagnosis, Thyroid Neoplasms genetics, Thyroid Neoplasms surgery, Thyroid Nodule diagnosis, Thyroid Nodule genetics, Thyroid Nodule pathology
- Abstract
Background: The diagnosis of cancer in Bethesda III/IV thyroid nodules is challenging as fine-needle aspiration (FNA) has limitations, and these cases usually require diagnostic surgery. As approximately 77% of these nodules are not malignant, a diagnostic test accurately identifying benign thyroid nodules can reduce "potentially unnecessary" surgery rates. We have previously reported the development and validation of a microRNA-based thyroid classifier (mir-THYpe) with high sensitivity and specificity, which could be performed directly from FNA smear slides. We sought to evaluate the performance of this test in real-world clinical routine to support clinical decisions and to reduce surgery rates., Methods: We designed a real-world, prospective, multicentre study. Molecular tests were performed with FNA samples prepared at 128 cytopathology laboratories. Patients were followed-up from March 2018 until surgery or until March 2020 (patients with no indication for surgery). The final diagnosis of thyroid tissue samples was retrieved from postsurgical anatomopathological reports., Findings: A total of 435 patients (440 nodules) classified as Bethesda III/IV were followed-up. The rate of avoided surgeries was 52·5% for all surgeries and 74·6% for "potentially unnecessary" surgeries. The test achieved 89·3% sensitivity, 81·65% specificity, 66·2% positive predictive value, and 95% negative predictive value. The test supported 92·3% of clinical decisions., Interpretation: The reported data demonstrate that the use of the microRNA-based classifier in the real-world can reduce the rate of thyroid surgeries with robust performance and support clinical decision-making., Funding: The São Paulo Research-Foundation (FAPESP) and Onkos., Competing Interests: Declaration of interests MTS holds equity at Onkos Molecular Diagnostics. BMR, SS, AFO and MO are formal employees at Onkos Molecular Diagnostics. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2022
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