FOIA Thyroid imaging reporting and data system for US features of nodules: a step in establishing better stratification of cancer risk. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. doi: 10.1210/jendso/bvaa031. 2022 Jan 6;2022:5623919. doi: 10.1155/2022/5623919. These nodules are relatively common and are usually harmless, but there is a very low risk of thyroid cancer. EU-TIRADS 2 category comprises benign nodules with a risk of malignancy close to 0%, presented on sonography as pure/anechoic cysts ( Figure 1A) or entirely spongiform nodules ( Figure 1B ). Cheng H, Zhuo SS, Rong X, Qi TY, Sun HG, Xiao X, Zhang W, Cao HY, Zhu LH, Wang L. Int J Endocrinol. . That particular test is covered by insurance and is relatively cheap. I have some serious news about my thyroid nodules today. 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. 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. Second, the proportion of patients in the different ACR TIRADS (TR) categories may, or may not, reflect the real-world population (Table 1). Test performance in the TR3 and TR4 categories had an accuracy of less than 60%. published a simplified TI-RADS that was prospectively validated 5. (2009) Thyroid : official journal of the American Thyroid Association. The actual number of inconclusive FNA results in the real-world validation set has not been established (because that study has not been done), but the typical rate is 30% (by this we mean nondiagnostic [ie, insufficient cells], or indeterminate [ie, atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS)/follicular neoplasm/suspicious for follicular neoplasm [Bethesda I, III, IV]). The difference was statistically significant (P<0.05). Your email address will not be published. The sensitivity, specificity, and accuracy of C-TIRADS were 93.1%, 55.3%, and 74.6% respectively. 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. Methods: This data set was a subset of data obtained for a previous study and there are no clear details of the inclusion and exclusion criteria, including criteria for FNA. In 2009, Park et al. 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. Furuya-Kanamori L, Bell KJL, Clark J, Glasziou P, Doi SAR. If a patient was happy taking this small risk (and particularly if the patient has significant comorbidities), then it would be reasonable to do no further tests, including no US, and instead do some safety netting by advising the patient to return if symptoms changed (eg, subsequent clinically apparent nodule enlargement). 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. So, the number needed to scan (NNS) for each additional person correctly reassured is 100 (NNS=100). There remains the need for a highly performing diagnostic modality for clinically important thyroid cancers. The high prevalence of thyroid nodules combined with the generally indolent growth of thyroid cancer present a challenge for optimal patient care. Furthermore, we are presuming other clinical factors (ie, palpability, size, number, symptoms, age, gender, prior radiation exposure, family history) add no diagnostic value above random selection. We chose a 1 in 10 FNA rate to reflect that roughly 5% of thyroid nodules are palpable and so would likely go forward for FNA, and we considered that a similar number would be selected for FNA based on clinical grounds such as other risk factors or the patient wishes. Your health care provider will examine your neck to feel for changes in your thyroid, such as a lump (nodule) in the thyroid. However, if the concern is that this might miss too many thyroid cancers, then this could be compared with the range of alternatives (ie, doing no tests or doing many more FNAs). Cystic or almost completely cystic 0 points. doi: 10.1016/S0140-6736(14)62242-X Value of Contrast-Enhanced Ultrasound in Adjusting the Classification of Chinese-TIRADS 4 Nodules. Clipboard, Search History, and several other advanced features are temporarily unavailable. The detection rate of thyroid cancer has increased steeply with widespread utilization of ultrasound (US) and frequent incidental detection of thyroid nodules with other imaging modalities such as computed tomography, magnetic resonance imaging, and, more recently, positron emission tomography-computed tomography, yet the mortality from thyroid cancer has remained static [10, 11]. Kwak JY, Han KH, Yoon JH et-al. As it turns out, its also very accurate and detailed. In rare cases, they're cancerous. Therefore, compared with randomly selecting 1 in 10 nodules for FNA, using ACR TIRADS to correctly rule out thyroid cancer in 1 additional patient would require more than 100 US scans (NNS>100) to find 25 TR1 and TR2 patients, triggering at least 40 additional FNAs and resulting in approximately 6 additional unnecessary diagnostic hemithyroidectomies at significant economic and personal costs. Finally, someone has come up with a guide to assist us GPs navigate this difficult but common condition. Its not something that happens every day, but every day. Now, the first step in T3N treatment is usually a blood test. 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. Anti-thyroid medications. Radiology. It is interesting to see the wealth of data used to support TIRADS as being an effective and validated tool. Any test will struggle to outperform educated guessing to rule out clinically important thyroid cancer. In CEUS analysis, it reflected as later arrival time, hypo-enhancement, heterogeneous and centripetal enhancement, getting a score of 4 in the CEUS model. A total of 228 thyroid nodules (C-TIRADS 4) were estimated by CEUS. It is also relevant to note that the change in nodule appearance over time is poorly predictive of malignancy. The provider may also ask about your risk factors, such as past exposure to radiation and a family history of thyroid cancers. All of the C-TIRADS 4 nodules were re-graded by CEUS-TIRADS. A TR5 cutoff would have NNS of 50 per additional cancer found compared with random FNA of 1 in 10 nodules, and probably a higher NNS if one believes that clinical factors can increase FNA hit rate above the random FNA hit rate. They will want to know what to do with your nodule and what tests to take. 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. Therefore, 60% of patients are in the middle groups (TR3 and TR4), where the US features are less discriminatory. Thyroid nodules are a common finding, especially in iodine-deficient regions. government site. TIRADS 5: probably malignant nodules (malignancy >80%). HHS Vulnerability Disclosure, Help Endocrinol. Multivariate factors logistic analysis was performed and a CEUS diagnostic schedule was established. 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. TIRADS ( T hyroid I maging R eporting and D ata S ystem) is a 5-point scoring system for thyroid nodules on ultrasound, developed by the American College of Radiology ( hence also termed as ACR- TIRADS). The chance of finding cancer is 1 in 20, whereas the chance of testing resulting in an unnecessary operation is around 1 in 7. Ultrasonographic scoring systems such as the Thyroid Imaging Reporting and Data System (TIRADS) are helpful in differentiating between benign and malignant thyroid nodules by offering a risk stratification model. 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 2 examples provide a range of performance within which the real test performance is likely to be, with the second example likely to provide TIRADS with a more favorable test performance than in the real world. FNA, fine-needle aspiration; US, ultrasound; CEUS, contrast-enhanced ultrasound; C-TIRADS, Chinese imaging reporting and data system. The results were compared with histology findings. If the proportions of patients in the different TR groups in the ACR TIRADs data set is similar to the real-world population, then the prevalence of thyroid cancer in the TR3 and TR4 groups is lower than in the overall population of patients with thyroid nodules. Objective: To determine whether the size of thyroid nodules in ACR-TIRADS ultrasound categories 3 and 4 is correlated with the Bethesda cytopathology classification. Disclaimer. Bongiovanni M, Spitale A, Faquin WC, Mazzucchelli L, Baloch ZW. Keywords: This allows patients with a TR1 or TR2 nodule to be reassured that they have a low risk of thyroid cancer, rather than a mixture of nodules (not just TR1 or TR2) not being able to be reassured. The sensitivity, specificity, and accuracy of CEUS were 78.7%, 87.5%, and 83.3% respectively. The sensitivity, specificity, and accuracy of CEUS-TIRADS were 95.7%, 85.7%, and 92.1% respectively. Thyroid nodules with TIRADS 4 and 5 and diameter lower than 12 mm, are highly suspicious for malignancy and should be considered as indications for fine needle aspiration biopsy. Therefore, using TIRADS categories TR1 or TR2 as a rule-out test should perform very well, with sensitivity of the rule-out test being 97%. Would you like email updates of new search results? 3, 4 The modified TI-RADS based on the ACR TI-RADS scoring system was sponsored by Wang et al. This paper has only examined the ACR TIRADS system, noting that other similar systems exist such as Korean TIRADS [14]and EU TIRADS [15]. We first estimate the performance of ACR TIRADS guidelines recommended approach to the initial decision to perform FNA, by using TR1 or TR2 as a rule-out test, or using TR5 as a rule-in test because applying TIRADS at the extremes of pretest cancer risk (TR1 and TR2 for lowest risk, and TR5 for highest risk), is most likely to perform best. Required fields are marked *. A minority of these nodules are cancers. 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). Taken as a capsule or in liquid form, radioactive iodine is absorbed by your thyroid gland. At the time the article was created Praveen Jha had no recorded disclosures. If a clinician does no tests and no FNAs, then he or she will miss all thyroid cancers (5 people per 100). 24;8 (10): e77927. There are even data showing a negative correlation between size and malignancy [23]. Yoon JH, Han K, Kim EK, Moon HJ, Kwak JY. 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. Putting aside any potential methodological concerns with ACR TIRADS, it may be helpful to illustrate how TIRADS might work if one assumed that the data set used was a fair approximation to the real-world population. The gender bias (92% female) and cancer prevalence (10%) of the data set suggests it may not accurately reflect the intended test population. Russ G, Royer B, Bigorgne C et-al. Unauthorized use of these marks is strictly prohibited. Thyroid nodules could be classified into one of 10 ultrasound patterns, which had a corresponding TI-RADS category. 2020 Chinese Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules: The. A normal finding in Finland. 2021 Oct 30;13(21):5469. doi: 10.3390/cancers13215469. The vast majority of nodules followed-up would be benign (>97%), and so the majority of FNAs triggered by US follow-up would either be benign, indeterminate, or false positive, resulting in more potential for harm (16 unnecessary operations for every 100 FNAs). This approach likely performs better than randomly selecting 1 in 10 nodules for FNA, but we intentionally made assumptions that would favor the performance of ACR TIRADS to illustrate that if a poor clinical comparator cannot clearly be beaten, then the clinical value that such new systems bring is correspondingly poor. It helps to decide if a thyroid nodule is benign or malignant by combining multiple features on ultrasound. Thyroid nodules are solid or fluid-filled lumps that form within your thyroid, a small gland located at the base of your neck, just above your breastbone. The more important test metric for diagnosing a disease is the specificity, where a positive test helps rule-in the disease. EU-TIRADS 1 category refers to a US examination where no thyroid nodule is found; there is no need for FNAB. Accessibility Performance of Contrast-Enhanced Ultrasound in Thyroid Nodules: Review of Current State and Future Perspectives. If one assumes that they do, then it is important to note that 25% of patients make up TR1 and TR2 and only 16% of patients make up TR5. 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%. eCollection 2022. Current thyroid cancer trends in the United States, Association between screening and the thyroid cancer epidemic in South Korea: evidence from a nationwide study, 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: the American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer, Thyroid ultrasound and the increase in diagnosis of low-risk thyroid cancer, Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology, Ultrasonography diagnosis and imaging-based management of thyroid nodules: revised Korean Society of Thyroid Radiology Consensus Statement and Recommendations, European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: the EU-TIRADS, Multiinstitutional analysis of thyroid nodule risk stratification using the American College of Radiology Thyroid Imaging Reporting and Data System, The Bethesda System for reporting thyroid cytopathology: a meta-analysis, The role of repeat fine needle aspiration in managing indeterminate thyroid nodules, The indeterminate thyroid fine-needle aspiration: experience from an academic center using terminology similar to that proposed in the 2007 National Cancer Institute Thyroid Fine Needle Aspiration State of the Science Conference. The diagnostic performance of CEUS-TIRADS was significantly better than CEUS and C-TIRADS. Perhaps the most relevant positive study is from Korea, which found in a TR4 group the cancer rate was no different between nodules measuring between 1-2 cm (22.3%) and those 2-3 cm (23.5%), but the rate did increase above 3 cm (40%) [24]. in 2009 1. 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. Now, the first step in T3N treatment is usually a blood test. Thus, the absolute risk of missing important cancer goes from 4.5% to 2.5%, so NNS=100/2=50. 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. Bookshelf TI-RADS 4c applies to the lesion with three to five of the above signs and/or a metastatic lymph node is present. The main source data set for the ACR TIRADS recommendations was large and consisted of US images and FNA results of more than 3400 nodules [16]. So, for 100 scans, if FNA is done on all TR5 nodules, this will find one-half of the cancers and so will miss one-half of the cancers. 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. Diagnosis and Management of Small Thyroid Nodules: A Comparative Study with Six Guidelines for Thyroid Nodules. Thyroid Tirads 4: Thyroid lesions with suspicious signs of malignancy. doi: 10.1111/j.1754-9485.2009.02060.x 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. Results: 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). 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. PMC J Adolesc Young Adult Oncol (2020) 9(2):2868. These patients are not further considered in the ACR TIRADS guidelines. However, given that TR1 and TR2 make up only 25% of the nodules, then to find 25 nodules that are TR1 or TR2, you would need to do 100 scans. Among thyroid nodules detected during life, the often quoted figure for malignancy prevalence is 5% [5-8], with UptoDate quoting 4% to 6.5% in nonsurgical series [9], and it is likely that only a proportion of these cancers will be clinically significant (ie, go on to cause ill-health). A proposal for a thyroid imaging reporting and data system for ultrasound features of thyroid carcinoma. Quite where the cutoff should be is debatable, but any cutoff below TR5 will have diminishing returns and increasing harms. Those working in this field would gratefully welcome a diagnostic modality that can improve the current uncertainty. The It might even need surge This comes at the cost of missing as many cancers as you find, spread amongst 84% of the population, and doing 1 additional unnecessary operation (160.20.8=2.6, minus the 1.6 unnecessary operations resulting from random selection of 1 in 10 patients for FNA [25]), plus the financial costs involved. Most nodules and swellings are not cancerous. For a rule-out test, sensitivity is the more important test metric. The. The low pretest probability of important thyroid cancer and the clouding effect of small clinically inconsequential thyroid cancers makes the development of an effective real-world test incredibly difficult. eCollection 2020 Apr 1. Well, there you have it. 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. This assumption is obviously not valid and favors TIRADS management guidelines, but we believe it is helpful for clarity and illustrative purposes. We then compare the diagnosis performance of C-TIRADS, CEUS, and CEUS-TIRADS by sensitivity, specificity, and accuracy. They're common, almost always noncancerous (benign) and usually don't cause symptoms. and transmitted securely. 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. The cost-effective diagnosis or exclusion of consequential thyroid cancer is an everyday problem faced by all thyroid clinicians. Radzina M, Ratniece M, Putrins DS, Saule L, Cantisani V. Cancers (Basel). What does highly suspicious thyroid nodule mean? This equates to 2-3 cancers if one assumes a thyroid cancer prevalence of 5% in the real world. Bessey LJ, Lai NB, Coorough NE, Chen H, Sippel RS. A re-analysis of thyroid imaging reporting and data system ultrasound scoring after molecular analysis is a cost-effective option to assist with preoperative diagnosis of indeterminate thyroid . A study that looked at all nodules in consecutive patients (eg, perhaps FNA of every nodule>10 mm) would be required to get an accurate measure of the cancer prevalence in those nodules that might not typically get FNA. Haymart MR, Banerjee M, Reyes-Gastelum D, Caoili E, Norton EC. Data Availability: All data generated or analyzed during this study are included in this published article or in the data repositories listed in References. spiker54. Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. Middleton WD, Teefey SA, Reading CC, et al. Unfortunately, the collective enthusiasm for welcoming something that appears to provide certainty has perhaps led to important flaws in the development of the models being overlooked. The present study evaluated the risk of malignancy in solid nodules>1 cm using ACR TI-RADS. Outlook. In a patient with normal life expectancy, a biopsy should be performed for nodules >1cm regardless of the ACR TI-RADS risk category. The equation was as follows: z = -2.862 + 0.581X1- 0.481X2- 1.435X3+ 1.178X4+ 1.405X5+ 0.700X6+ 0.460X7+ 0.648X8- 1.715X9+ 0.463X10+ 1.964X11+ 1.739X12. It is important to validate this classification in different centres. To illustrate the effect of the size cutoffs we have given 2 examples, 1 where the size cutoffs are not discriminatory and the cancer rate is the same above and below the size cutoff, and the second example where the cancer risk of the nodule doubles once the size goes above the cutoff. J Med Imaging Radiat Oncol (2009) 53(2):17787. In: Thyroid 26.1 (2016), pp. The probability of malignancy was based on an equation derived from 12 features 2. The key next step for any of the TIRADS systems, and for any similar proposed test system including artificial intelligence [30-32], is to perform a well-designed prospective validation study to measure the test performance in the population upon which it is intended for use. TIRADS 6: category included biopsy proven malignant nodules. Interobserver Agreement of Thyroid Imaging Reporting and Data System (TIRADS) and Strain Elastography for the Assessment of Thyroid Nodules. With the right blood tests, you can see if you have a thyroid nodule, and if so, you can treat it with radioactive iodine. If one accepts that the pretest probability of a patient presenting with a thyroid nodule having an important thyroid cancer is 5%, then clinicians who tell every patient they see that they do not have important thyroid cancer will be correct 95% of the time. Third, when moving on from the main study in which ACR TIRADS was developed [16] to the ACR TIRADS white paper recommendations [22], the TIRADS model changed by the addition of a fifth US characteristic (taller than wide), plus the addition of size cutoffs. Jin Z, Zhu Y, Lei Y, Yu X, Jiang N, Gao Y, Cao J. Med Sci Monit. Using TR5 as a rule-in test was similar to random selection (specificity 89% vs 90%). 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%.