We realize that such factors may increase an individuals pretest probability of cancer and clinical decision-making would change accordingly (eg, proceeding directly to FNA), but we here ascribe no additional diagnostic value to avoid overestimating the performance of the clinical comparator. Friedrich-Rust M, Meyer G, Dauth N et-al. Disclaimer. The more important test metric for diagnosing a disease is the specificity, where a positive test helps rule-in the disease. Your health care provider will examine your neck to feel for changes in your thyroid, such as a lump (nodule) in the thyroid. Thyroid nodules are very common and benign in most cases. Management of nodules with initially nondiagnostic results of thyroid fine-needle aspiration: can we avoid repeat biopsy? We then compare the diagnosis performance of C-TIRADS, CEUS, and CEUS-TIRADS by sensitivity, specificity, and accuracy. Using TR5 as a rule-in test was similar to random selection (specificity 89% vs 90%). Many of these papers share the same fundamental problem of not applying the test prospectively to the population upon which it is intended for use. If one assumes that in the real world, 25% of the patients have a TR1 or TR2 nodule, applying TIRADS changes the pretest 5% probability of cancer to a posttest risk of 1%, so the absolute risk reduction is 4%. The Thyroid Imaging Reporting and Data System (TI-RADS) of the American College of Radiology (ACR) was designed in 2017 with the intent to decrease biopsies of benign nodules and improve overall . The figures that TIRADS provide, such as cancer prevalence in certain groups of patients, or consequent management guidelines, only apply to populations that are similar to their data set. Performance of Contrast-Enhanced Ultrasound in Thyroid Nodules: Review of Current State and Future Perspectives. We then compare the diagnosis performance of C-TIRADS, CEUS, and CEUS-TIRADS by sensitivity, specificity, and accuracy. Copyright 2022 Zhu, Chen, Zhou, Ma and Huang. Diag (Basel) (2021) 11(8):137493. The data set was 92% female and the prevalence of cancerous thyroid nodules was 10.3% (typical of the rate found on histology at autopsy, and double the 5% rate of malignancy in thyroid nodules typically quoted in the most relevant literature). What does highly suspicious thyroid nodule mean? After repeat US-guided FNA, some patients achieve a cytological diagnosis, but typically two-thirds remain indeterminate [18], accounting for approximately 20% of initial FNAs (eg, 10%-30% [12], 31% [19], 22% [20]). Instead, it has been applied on retrospective data sets, with cancer rates far above 5%, rather than on consecutive unselected patients presenting with a thyroid nodule [33]. Test performance in the TR3 and TR4 categories had an accuracy of less than 60%. Summary Test Performance of Random Selection of 1 in 10 Nodules for FNA, Compared with ACR-TIRADS. 3. Those wishing to continue down the investigative route could then have US, using TIRADS or ATA guidelines or other measures to offer some relative risk-stratification. Treatment of patients with the left lobe of the thyroid gland, tirads 3 Therefore, for every 25 patients scanned (100/4=25) and found to be either TR1 or TR2, 1 additional person would be correctly reassured that they do not have thyroid cancer. Endocrinol. Park JY, Lee HJ, Jang HW, Kim HK, Yi JH, Lee W, Kim SH. doi: 10.3390/diagnostics11081374 To establish a contrast-enhanced ultrasound (CEUS) diagnostic schedule by CEUS analysis of thyroid nodules of C-TIRADS 4. ADVERTISEMENT: Radiopaedia is free thanks to our supporters and advertisers. Lancet (2014) 384(9957): 1848:184858. All of the C-TIRADS 4 nodules were re-graded by CEUS-TIRADS. to propose a simpler TI-RADS in 2011 2. Any additional test has to perform exceptionally well to surpass this clinicians 95% negative predictive performance, without generating false positive results and consequential harm. Haymart MR, Banerjee M, Reyes-Gastelum D, Caoili E, Norton EC. It helps to decide if a thyroid nodule is benign or malignant by combining multiple features on ultrasound. If one decides to FNA every TR5 nodule, from the original ACR TIRADS data set, 34% were found to be cancerous, but note that this data set likely has double the prevalence of thyroid cancer compared with the real-world population. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. This study aimed to assess the performance and costs of the American College of Radiology (ACR) Thyroid Image Reporting And Data System (TIRADS), by first looking for any important issues in the methodology of its development, and then illustrating the performance of TIRADS for the initial decision for or against FNA, compared with an imagined The process of validation of CEUS-TIRADS model. The diagnosis or exclusion of thyroid cancer is hugely challenging. 24;8 (10): e77927. The https:// ensures that you are connecting to the 2. Ultimately, most of these turn out to be benign (80%), so for every 100 FNAs, you end up with 16 (1000.20.8) unnecessary operations being performed. Whereas using TIRADS as a rule-in cancer test would be the finding that a nodule is TR5, with a sufficiently high chance of cancer that further investigations are required, compared with being TR1-4. To find 16 TR5 nodules requires 100 people to be scanned (assuming for illustrative purposes 1 nodule per scan). Sensitivity of ACR TIRADS was better than random selection, between 74% to 81% (depending on whether the size cutoffs add value) compared with 1% with random selection. EU-TIRADS 1 category refers to a US examination where no thyroid nodule is found; there is no need for FNAB. Results: eCollection 2022. Whilst we somewhat provocatively used random selection as a clinical comparator, we do not mean to suggest that clinicians work in this way. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). At the time the article was last revised Yuranga Weerakkody had Cavallo A, Johnson DN, White MG, et al. FNA, fine-needle aspiration; US, ultrasound; CEUS, contrast-enhanced, A 38-year-old woman with a nodule in the right-lobe of her thyroid gland., A 35-year-old woman with a nodule in the left-lobe of her thyroid gland., The ROC curves of C-TIRADS, CEUS, and CEUS-TIRADS of 228 nodules in the. Furuya-Kanamori L, Bell KJL, Clark J, Glasziou P, Doi SAR. 2022 Jul;41(7):1753-1761. doi: 10.1002/jum.15858. Methodologically, the change in the ACR-TIRADS model should now undergo a new study using a new training data set (to avoid replicating any bias), before then undergoing a validation study. The authors proposed the following criteria, based on French Endocrine Society guidelines, for when to proceed with fine needle aspiration biopsy: ADVERTISEMENT: Supporters see fewer/no ads, Please Note: You can also scroll through stacks with your mouse wheel or the keyboard arrow keys. PET-positive thyroid nodules have a relatively high malignancy rate of 35%. The consequences of these proportions are highly impactful when considering the real-world performance of ACR-TIRADS. The other one-half of the cancers that are missed by only doing FNA of TR5 nodules will mainly be in the TR3 and TR4 groups (that make up 60% of the population), and these groups will have a 3% to 8% chance of cancer, depending upon whether the population prevalence of thyroid cancer in those being tested is 5% or 10%. Recently, the American College of Radiology (ACR) proposed a Thyroid Imaging Reporting and Data System (TI-RADS) for thyroid nodules based on ultrasonographic features. PLoS ONE. A systematic autopsy study, The incidence of thyroid cancer by fine needle aspiration varies by age and gender, Thyroid cancer in the thyroid nodules evaluated by ultrasonography and fine-needle aspiration cytology, Comparison of 5-tiered and 6-tiered diagnostic systems for the reporting of thyroid cytopathology: a multi-institutional study. The Value of Chinese Thyroid Imaging Report and Data System Combined With Contrast-Enhanced Ultrasound Scoring in Differential Diagnosis of Benign and Malignant Thyroid Nodules. doi: 10.1016/S0140-6736(14)62242-X doi: 10.1210/jendso/bvaa031. In 2017, the Thyroid Imaging Reporting and Data System (TI-RADS) Committee of the American College of Radiology (ACR) published a white paper that presented a new risk-stratification system for classifying thyroid nodules on the basis of their appearance at ultrasonography (US). However, these assumptions have intentionally been made to favor the expected performance of ACR-TIRADS, and so in real life ACR-TIRADS can be expected to perform less well than we have illustrated. The financial costs and surgical morbidity in this group must be taken into account when considering the cost/benefit repercussions of a test that includes US imaging for thyroid cancer. Unauthorized use of these marks is strictly prohibited. Among the 228 C-TIRADS 4 nodules, 69 were determined as C-TIRADS 4a, 114 were C-TIRADS 4b, and 45 were C-TIRADS 4c. 7. Your email address will not be published. Thyroid imaging reporting and data system for US features of nodules: a step in establishing better stratification of cancer risk. Differentiation of Thyroid Nodules (C-TIRADS 4) by Combining Contrast-Enhanced Ultrasound Diagnosis Model With Chinese Thyroid Imaging Reporting and Data System Front Oncol. A prospective validation study that determines the true performance of TIRADS in the real-world is needed. Now you can go out and get yourself a thyroid nodule. The present study evaluated the risk of malignancy in solid nodules>1 cm using ACR TI-RADS. Would you like email updates of new search results? [The diagnostic performance of 2020 Chinese Ultrasound Thyroid Imaging Reporting and Data System in thyroid nodules]. Zhang B, Tian J, Pei S, Chen Y, He X, Dong Y, Zhang L, Mo X, Huang W, Cong S, Zhang S. Wildman-Tobriner B, Buda M, Hoang JK, Middleton WD, Thayer D, Short RG, Tessler FN, Mazurowski MA. Alternatively, if random FNAs are performed in 1 in 10 nodules, then 4.5 thyroid cancers (4-5 people per 100) will be missed. We examined the data set upon which ACR-TIRADS was developed, and applied TR1 or TR2 as a rule-out test, TR5 as a rule-in test, or applied ACR-TIRADS across all nodule categories. These appear to share the same basic flaw as the ACR-TIRADS, in that the data sets of nodules used for their development is not likely to represent the population upon which it is intended for use, at least with regard to pretest probability of malignancy (eg, malignancy rate 12% for Korean TIRADS [26]; 18% and 31% for EU TIRADS categories 4 and 5 [27, 28]). We have also estimated the likely costs associated with using the ACR TIRADS guidelines, though for simplicity have not included the costs of molecular testing for indeterminate nodules (which is not readily available in the New Zealand public health system) nor any US follow-up and associated costs. 8600 Rockville Pike 1. Shin JH, Baek JH, Chung J, et al. Given that ACR TIRADS test performance is at its worst in the TR3 and TR4 groups, then the cost-effectiveness of TIRADS will also be at its worst in these groups, in particular because of the false-positive TIRADS results. Other similar systems are in use internationally (eg, Korean-TIRADS [14] and EU-TIRADS [15]). If you assume that FNA is done as per reasonable application of TIRADS recommendations (in all patients with TR5 nodules, one-half of patients with TR4 nodules and one-third of patients with TR3 nodules) and the proportion of patients in the real world have roughly similar proportion of TR nodules as the data set used, then 100 US scans would result in FNAs of about one-half of all patients scanned (of data set, 16% were TR5, 37% were TR4, and 23% were TR3, so FNA number from 100 scans=16+(0.537)+(0.323)=42). The sensitivity, specificity, and accuracy of CEUS were 78.7%, 87.5%, and 83.3% respectively. Tessler FN, Middleton WD, Grant EG, et al. The gender bias (92% female) and cancer prevalence (10%) of the data set suggests it may not accurately reflect the intended test population. Whilst our findings have illustrated some of the shortcomings of ACR TIRADS guidelines, we are not able to provide the ideal alternative. Anderson TJ, Atalay MK, Grand DJ, Baird GL, Cronan JJ, Beland MD. Authors Tiantong Zhu 1 , Jiahui Chen 1 , Zimo Zhou 2 , Xiaofen Ma 1 , Ying Huang 1 Affiliations In 2013, Russ et al. If the nodule got a score of more than 2 in the CEUS schedule, CEUS-TIRADS added 1 category. doi: 10.1007/s12020-020-02441-y Applying ACR-TIRADS across all nodule categories did not perform well, with sensitivity and specificity between 60% and 80% and overall accuracy worse than random selection (65% vs 85%). It would be unfair to add these clinical factors to only the TIRADS arm or only to the clinical comparator arm, and they would cancel out if added to both arms, hence they were omitted. However, the consequent management guidelines are difficult to justify at least on a cost basis for a rule-out test, though ACR TIRADS may provide more value as a rule-in test for a group of patients with higher cancer risk. Until a well-designed validation study is completed, the performance of TIRADS in the real world is unknown. Unable to load your collection due to an error, Unable to load your delegates due to an error. ectomy, Parotid gland surgery, Transoral laser microsurgery, Transoral robotic surgery, Oral surgery, Parotid gland tumor, Skin cancer, Tonsil cancer, Throat cancer, Salivary gland tumor, Salivary gland cancer, Thyroid nodule, Head and neck cancer, Laryngeal cancer, Tongue . No focal lesion. The implication is that US has enabled increased detection of thyroid cancers that are less clinically important [11-13]. published a simplified TI-RADS that was prospectively validated 5. We have also assumed that all nodules are at least 10 mm and so the TR5 nodule size cutoff of 5 mm does not apply. The system has fair interobserver agreement 4. Therefore, taking results from this data set and assuming they would apply to the real-world population raises concerns. Data sets with a thyroid cancer prevalence higher than 5% are likely to either include a higher proportion of small clinically inconsequential thyroid cancers or be otherwise biased and not accurately reflect the true population prevalence. The true test performance can only be established once the optimized test has been applied to 1 or more validation data sets and compared with the existing gold standard test. Until TIRADS is subjected to a true validation study, we do not feel that a clinician can currently accurately predict what a TIRADS classification actually means, nor what the most appropriate management thereafter should be. TR5 in the data set made up 16% of nodules, in which one-half of the thyroid cancers (183/343) were found. K-TIRADS category was assigned to the thyroid nodules. That particular test is covered by insurance and is relatively cheap. The difference was statistically significant (P<0.05). Chinese thyroid imaging reporting and data system(C-TIRADS); contrast-enhanced ultrasound (CEUS); differentiation; thyroid nodules; ultrasound (US). Those working in this field would gratefully welcome a diagnostic modality that can improve the current uncertainty. Horvath E, Majlis S, Rossi R et-al. We refer to ACR-TIRADS where data or comments are specifically related to ACR TIRADS and use the term TIRADS either for brevity or when comments may be applicable to other TIRADS systems. Objective: To determine whether the size of thyroid nodules in ACR-TIRADS ultrasound categories 3 and 4 is correlated with the Bethesda cytopathology classification. eCollection 2022. J Med Imaging Radiat Oncol (2009) 53(2):17787. Thus, the absolute risk of missing important cancer goes from 5% (with no FNAs) to 2.5% using TIRADS and FNA of all TR5, so NNS=100/2.5=40. Once the test is considered to be performing adequately, then it would be tested on a validation data set. The gold test standard would need to be applied for comparison. If a patient presented with symptoms (eg, concerns about a palpable nodule) and/or was not happy accepting a 5% pretest probability of thyroid cancer, then further investigations could be offered, noting that US cannot reliably rule in or rule out thyroid cancer for the majority of patients, and that doing any testing comes with unintended risks. 2011;260 (3): 892-9. Thyroid imaging reporting and data system (TI-RADS). So, the number needed to scan (NNS) for each additional person correctly reassured is 100 (NNS=100). The. Noticeably benign pattern (0% risk of malignancy) TI-RADS 3: Probably benign nodules (<5% risk of malignancy) TI-RADS 4: 4a - Undetermined nodules (5-10% risk of malignancy) Score of 1. Diagnosis and Management of Small Thyroid Nodules: A Comparative Study with Six Guidelines for Thyroid Nodules. Cystic or almost completely cystic 0 points. The ACR TIRADS white paper [22] very appropriately notes that the recommendations are intended to serve as guidance and that professional judgment should be applied to every case including taking into account factors such as a patients cancer risk, anxiety, comorbidities, and life expectancy. The provider may also ask about your risk factors, such as past exposure to radiation and a family history of thyroid cancers. Compared with randomly doing FNA on 1 in 10 nodules, using ACR TIRADS and doing FNA on all TR5 requires NNS of 50 to find 1 additional cancer. The following article describes the initial iterations proposed by individual research groups, none of which gained widespread use. The challenge of appropriately balancing the risks of missing an important cancer versus the chance of causing harm and incurring significant costs from overinvestigation is major. If the nodule had a regular hyper-enhancement ring or got a score of less than 2 in CEUS analysis, CEUS-TIRADS subtracted 1 category. Depending on the constellation or number of suspicious ultrasound features, a fine-needle biopsy is . The ROC curves of C-TIRADS, CEUS, and CEUS-TIRADS of 228 nodules in the diagnostic model. The problem is that many people dont know that they have a thyroid nodule, so they dont know how to treat it. There remains the need for a highly performing diagnostic modality for clinically important thyroid cancers. Taken as a capsule or in liquid form, radioactive iodine is absorbed by your thyroid gland. It has been retrospectively applied to thyroidectomy specimens, which is clearly not representative of the patient presenting with a thyroid nodule [34-36], and has even been used on the same data set used for TIRADS development, clearly introducing obvious bias [32, 37]. To further enhance the performance of TIRADS, we presume that patients present with only 1 TR category of thyroid nodules. Because the data set prevalence of thyroid cancer was 10%, compared with the generally accepted lower real-world prevalence of 5%, one can reasonably assume that the actual cancer rate in the ACR TIRADS categories in the real world would likely be one-half that quoted from the ACR TIRADS data set, which we illustrate in the following section. The nodules were scored, measured and assigned to one of five TI-RADS levels (TR): TR1 - benign, TR2 - not suspicious, TR3 - mildly suspicious, TR4 - moderately suspicious, TR5 - highly suspicious. Russ G, Royer B, Bigorgne C et-al. -, Takano T. Overdiagnosis of Juvenile Thyroid Cancer: Time to Consider Self-Limiting Cancer. Thyroid nodules could be classified into one of 10 ultrasound patterns, which had a corresponding TI-RADS category. Many studies have not found a clear size/malignancy correlation, and where it has been found, the magnitude of the effect is modest. An ultrasonogram reporting system for thyroid nodules stratifying cancer risk for clinical management. In 2009, Park et al. The authors suggested, as with BI-RADS, that biopsy candidates were those nodules categorized as TI-RADS category 4 or 5, meaning demonstrating at least one suspicious sonographic feature. Hong MJ, Na DG, Baek JH, Sung JY, Kim JH. A key factor is the low pretest probability of important thyroid cancer but a higher chance of finding thyroid cancers that are very unlikely to cause ill health during a persons lifetime. Therefore, the rates of cancer in each ACR TIRADS category in the data set where they used four US characteristics can no longer be assumed to be the case using the 5 US characteristics plus the introduction of size cutoffs. Thyroid nodules come to clinical attention when noted by the patient; by a clinician during routine physical examination; or during a radiologic procedure, such as carotid ultrasonography, neck or chest computed tomography (CT), or positron emission tomography (PET) scanning. The management guidelines may be difficult to justify from a cost/benefit perspective. A 35-year-old woman with a nodule in the left-lobe of her thyroid gland. Im on a treatment plan with my oncologist, my doctor, and Im about to start my next round of treatments. For TIRADS to add clinical value, it would have to clearly outperform the comparator (random selection), particularly because we have made some assumptions that favor TIRADS performance. Thyroid imaging reporting and data system (TI-RADS)refers to any of several risk stratification systems for thyroid lesions, usually based on ultrasound features, with a structure modelled off BI-RADS. However, many patients undergoing a PET scan will have another malignancy. TIRADS 5: probably malignant nodules (malignancy >80%). Diagnostic approach to and treatment of thyroid nodules. 2020 Mar 10;4 (4):bvaa031. But the test that really lets you see a nodule up close is a CT scan. In the TR3 category, there was a gradual difference in cancer rate in those 1-2 cm (6.5%), and those 2-3 cm (8.4%) and those>3 cm (11.3%). Clinical Application of C-TIRADS Category and Contrast-Enhanced Ultrasound in Differential Diagnosis of Solid Thyroid Nodules Measuring 1 cm. Zhonghua Yi Xue Za Zhi. NCI Thyroid FNA State of the Science Conference, The Bethesda System for reporting thyroid cytopathology, ACR Thyroid Imaging, Reporting and Data System (TI-RADS): white paper of the ACR TI-RADS Committee, Thyroid nodule size at ultrasound as a predictor of malignancy and final pathologic size, Impact of nodule size on malignancy risk differs according to the ultrasonography pattern of thyroid nodules, TIRADS management guidelines in the investigation of thyroid nodules; an illustration of the concerns, costs and performance, Thyroid nodules with minimal cystic changes have a low risk of malignancy, [The Thyroid Imaging Reporting and Data System (TIRADS) for ultrasound of the thyroid], Malignancy risk stratification of thyroid nodules: comparison between the Thyroid Imaging Reporting and Data System and the 2014 American Thyroid Association Management Guidelines, Validation and comparison of three newly-released Thyroid Imaging Reporting and Data Systems for cancer risk determination, Machine learning-assisted system for thyroid nodule diagnosis, Automatic thyroid nodule recognition and diagnosis in ultrasound imaging with the YOLOv2 neural network, Using artificial intelligence to revise ACR TI-RADS risk stratification of thyroid nodules: diagnostic accuracy and utility, A multicentre validation study for the EU-TIRADS using histological diagnosis as a gold standard, Comparison among TIRADS (ACR TI-RADS and KWAK- TI-RADS) and 2015 ATA Guidelines in the diagnostic efficiency of thyroid nodules, Prospective validation of the ultrasound based TIRADS (Thyroid Imaging Reporting And Data System) classification: results in surgically resected thyroid nodules, Diagnostic performance of practice guidelines for thyroid nodules: thyroid nodule size versus biopsy rates, Comparison of performance characteristics of American College of Radiology TI-RADS, Korean Society of Thyroid Radiology TIRADS, and American Thyroid Association Guidelines, Performance of five ultrasound risk stratification systems in selecting thyroid nodules for FNA. Here at the University of Florida, we are currently recruiting endocrinologists to work with us to help people with thyroid nodules. In view of their critical role in thyroid nodule management, more improved TI-RADSs have emerged. 2020 Chinese Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules: The. The truth is, most of us arent so lucky as to be diagnosed with all forms of thyroid cancer, but we do live with the results of it. The test that really lets you see a nodule up close is a CT scan. This equates to 2-3 cancers if one assumes a thyroid cancer prevalence of 5% in the real world. The site is secure. The current ACR TIRADS system changed from that assessed during training, with the addition of the taller-than-wide and size criteria, which further questions the assumption that the test should perform in the real world as it did on a the initial training data set. If it performs well enough, then the test is applied to a training set of data to better establish performance characteristics. In rare cases, they're cancerous. The most common reason for our diagnosis is the thyroid nodule, a growth that often develops on the thyroid, the organ that controls our metabolism. Most nodules and swellings are not cancerous. Such guidelines do not detail the absolute risk of finding or missing a cancer, nor the often excellent outcome of the treatment of thyroid cancer, nor the potential for unnecessary operations. 4. Because we have a lot of people who have been put in a position where they dont have the proper education to be able to learn what were going through, we have to take this time and go through it as normal. Such a study should also measure any unintended harm, such as financial costs and unnecessary operations, and compare this to any current or gold standard practice against which it is proposed to add value. The flow chart of the study. Based on the 2017 ACR TIRADS classification, the doctor will continue to specify whether the patient needs a biopsy of thyroid cells or not: Thyroid nodule size > 2.5cm: Indication for cytology biopsy. Cawood T, Mackay GR, Hunt PJ, OShea D, Skehan S, Ma Y. Russ G, Bigorgne C, Royer B, Rouxel A, Bienvenu-Perrard M. Yoon JH, Lee HS, Kim EK, Moon HJ, Kwak JY. Thyroid nodule size from 1.5 - 2.5cm: Periodic follow-up every 6 months. However, the ACR TIRADS flow chart with its sharp cutoffs conveys a degree of certainty that may not be valid and may be hard for the clinician to resist. -, Zhou J, Yin L, Wei X, Zhang S, Song Y, Luo B, et al. Bookshelf If you do 100 (or more) US scans on patients with a thyroid nodule and apply the ACR TIRADS management guidelines for FNA, this results in costs and morbidity from the resultant FNAs and the indeterminate results that are then considered for diagnostic hemithyroidectomy. As it turns out, its also very accurate and detailed. With the right blood tests, you can see if you have a thyroid nodule, and if so, you can treat it with radioactive iodine. The authors stated that TI-RADS 4 and 5 nodules must be biopsied. If a clinician does no tests and no FNAs, then he or she will miss all thyroid cancers (5 people per 100). The costs depend on the threshold for doing FNA. Thyroid radiology practice has an important clinical role in the diagnosis and non-surgical treatment of patients with thyroid nodules, and should be performed according to standard practice guidelines for proper and effective clinical care. Another clear limitation of this study is that we only examined the ACR TIRADS system. We found sensitivity and PPV with TIRADS was poor, but was better than random selection (sensitivity 53% vs 1%, and PPV 34% vs 1%) whereas specificity, NPV, and accuracy was no better with TIRADS compared with random selection (specificity 89% vs 90%, NPV 94% vs 95%, and accuracy 85% vs 85%), Table 2 [25]. A robust validation study is required before the performance and cost-benefit outcomes of any of the TIRADS systems can be known. The optimal investigation and management of the 84% of the population harboring the remaining 50% of cancer remains unresolved. For this, we do not take in to account nodule size because size is not a factor in the ACR TIRADS guidelines for initial FNA in the TR1 and TR2 categories (where FNA is not recommended irrespective of size) or in the TR5 category (except in TR5 nodules of0.5 cm to<1.0 cm, in which case US follow-up is recommended rather than FNA).

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