Cost-Effectiveness of a Novel Molecular Test for Cytologically Indeterminate Thyroid Nodules

Division of Health Sciences Informatics, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, USA.
The Journal of Clinical Endocrinology and Metabolism (Impact Factor: 6.21). 08/2011; 96(11):E1719-26. DOI: 10.1210/jc.2011-0459
Source: PubMed


Determining which patients with thyroid nodules require surgery is limited by cytologically indeterminate findings. A new approach for preoperative molecular classification of cytologically indeterminate thyroid nodules has a reported sensitivity of 91% and specificity of 75%; however, its cost-effectiveness has yet to be assessed.
Our objective was to evaluate the 5-yr cost-effectiveness of routine use of a molecular test in adult patients with indeterminate fine-needle aspiration biopsy results from a societal perspective.
A 16-state Markov decision model was developed. Probabilities, costs, and quality-adjusted life years (QALY) were estimated from literature review, U.S. Department of Health and Human Services data, Medicare reimbursement schedules, and expert opinion.
Decision analysis of a hypothetical group of adult patients with cytologically indeterminate thyroid nodules was conducted.
Incremental cost-effectiveness ratio was calculated as incremental cost (measured in U.S. dollars) divided by incremental effectiveness (measured in QALY).
Modifying current practice with use of the molecular test resulted in 74% fewer surgeries for benign nodules with no greater number of untreated cancers. Over 5 yr, mean discounted cost estimates were $12,172 for current practice and $10,719 with the molecular test. Current practice and molecular test use produced 4.50 and 4.57 QALY, respectively.
Use of this novel molecular test for differential diagnosis of cytologically indeterminate thyroid nodules can potentially avoid almost three fourths of currently performed surgeries in patients with benign nodules. Compared with current practice based on cytological findings alone, use of this test may result in lower overall costs and modestly improved quality of life for patients with indeterminate thyroid nodules.

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    • "The combination of cytologic diagnosis and testing for the BRAFV600E mutation has improved the overall diagnostic performance of US-guided FNA.6 However, checking for the BRAFV600E mutation can cause misinterpretation due to false positive results-although this occurs rarely-as well as an elevation of medical costs.7,8 "
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    ABSTRACT: Purpose We investigated the merit of ultrasound (US) features and BRAFV600E mutation as an additional study of cytology and compared the diagnostic performances of cytology alone, cytology with US correlation, cytology with BRAFV600E mutation, and a combination of cytology, US, and BRAFV600E mutation all together. Materials and Methods This study included 185 patients (mean age, 48.4 years; range 20-77 years) with 191 thyroid nodules who underwent US-guided fine-needle aspiration (FNA) with an additional BRAFV600E mutation test. Three radiologists highly experienced in thyroid imaging retrospectively reviewed US images and classified each nodule into two categories (positive for malignancy or negative for malignancy). Interobserver variability (IOV) of US assessment between the three readers was estimated using the generalized kappa statistic of Landis and Koch. We also calculated the diagnostic performances of these studies. Results There were 131 cases of malignancy (131/191, 68.6%) and 60 cases of benign nodules (60/191, 31.4%). In terms of IOV of US assessment, the generalized kappa value was 0.242, indicating fair agreement was reached. The combination of cytology with BRAFV600E showed higher specificity (100%) and positive predictive value (PPV) (100%) compared to the combination of cytology, BRAFV600E, and US (specificity 28.3%, 66.7%, 68.3%; PPV 74.6%, 86.6%, 86.8%, respectively; p<0.001). However, cytology with BRAFV600E showed lower sensitivity (84.7%) than cytology with BRAFV600E and US (96.2%, 98.5%, 95.4%, respectively; p<0.001). Conclusion Considering the diagnostic performance and low reproducibility of US, the combination of FNA with BRAFV600E is the most reliable and objective method for diagnosing thyroid malignancy.
    Full-text · Article · Jul 2014 · Yonsei Medical Journal
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    • "Current clinical practice is to perform an ultrasound guided transcutaneous fine needle aspiration biopsy (FNAB) followed by a cytological examination of the aspirated cells from the thyroid nodule [3]. An estimated 625,000 FNA thyroid biopsies are performed annually in the US alone [6]. This technique can be performed in an outpatient clinic and offers few side effects from the procedure. "
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    ABSTRACT: Thyroid nodules are a frequent clinical finding and the most common endocrine malignancy is thyroid cancer. The standard of care in the management of a patient with a thyroid nodule is to perform a preoperative fine needle aspiration (FNA) biopsy of the suspect nodule under ultrasound imaging guidance. In a significant percentage of the cases, cytological assessment of the biopsy material yields indeterminate results, the consequence of which is diagnostic thyroidectomy. Unfortunately, 75-80% of diagnostic thyroidectomies following indeterminate cytology result in benign designation by post-surgery histopathology, indicating potentially unnecessary surgeries. Clearly, the potential exists for the improvement in patient care and the reduction of overall procedure costs if an improved preoperative diagnostic technique was developed. Elastic scattering spectroscopy (ESS) is an optical biopsy technique that is mediated by optical fiber probes and has been shown to be effective in differentiating benign from malignant thyroid tissue in ex vivo surgical tissue samples. The goal of the current research was to integrate the ESS fiber optic probes into a device that can also collect cells for cytological assessment and, thus, enable concurrent spectroscopic interrogation and biopsy of a suspect nodule with a single needle penetration. The primary challenges to designing the device included miniaturizing the standard ESS fiber optic probe to fit within an FNA needle and maintaining the needle's aspiration functionality. We demonstrate the value of the fabricated prototype devices by assessing their preliminary performance in an on-going clinical study with >120 patients. The devices have proven to be clinically friendly, collecting both aspirated cells and optical data from the same location in thyroid nodules and with minimal disruption of clinical procedure. In the future, such integrated devices could be used to complement FNA-based cytological results and have the potential to both reduce the number of diagnostic thyroidectomies on benign nodules and improve the surgical approach for patients with thyroid malignancies, thereby, decreasing healthcare costs and improving patient outcomes.
    Full-text · Article · Jun 2014 · Journal of Medical Devices
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    • "A considerable number of patients with equivocal findings are referred for surgery despite histopathological evaluation of the nodule after surgery revealing no malignancy [4]. It is estimated that around 75 000 surgeries for nodules with undetermined diagnoses are performed each year in the United States alone [8]; therefore, with a sound systematic approach, at least one third of these operations could be avoided [9]. Decision support systems that take advantage of computerized learning algorithms have been successfully applied in many areas of medicine and these have yielded diagnostic rates comparable or sometimes exceeding sophisticated diagnostic techniques and the clinical judgment of the physician [10] [11] [12] [13]. "
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    ABSTRACT: Purpose. We sought to investigate the utility of classification and regression trees (CART) classifier to differentiate benign from malignant nodules in patients referred for thyroid surgery. Methods. Clinical and demographic data of 271 patients referred to the Sadoughi Hospital during 2006–2011 were collected. In a two-step approach, a CART classifier was employed to differentiate patients with a high versus low risk of thyroid malignancy. The first step served as the screening procedure and was tailored to produce as few false negatives as possible. The second step identified those with the lowest risk of malignancy, chosen from a high risk population. Sensitivity, specificity, positive and negative predictive values (PPV and NPV) of the optimal tree were calculated. Results. In the first step, age, sex, and nodule size contributed to the optimal tree. Ultrasonographic features were employed in the second step with hypoechogenicity and/or microcalcifications yielding the highest discriminatory ability. The combined tree produced a sensitivity and specificity of 80.0% (95% CI: 29.9–98.9) and 94.1% (95% CI: 78.9–99.0), respectively. NPV and PPV were 66.7% (41.1–85.6) and 97.0% (82.5–99.8), respectively. Conclusion. CART classifier reliably identifies patients with a low risk of malignancy who can avoid unnecessary surgery.
    Full-text · Article · Sep 2013 · Journal of Thyroid Research
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