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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. 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. Diagnostic approach to and treatment of thyroid nodules. J Adolesc Young Adult Oncol (2020) 9(2):2868. The system is sometimes referred to as TI-RADS French 6. The flow chart of the study. 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. 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. As it turns out, its also very accurate and detailed. 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. Whilst we somewhat provocatively used random selection as a clinical comparator, we do not mean to suggest that clinicians work in this way. Cao H, Fan Q, Zhuo S, Qi T, Sun H, Rong X, Xiao X, Zhang W, Zhu L, Wang L. J Ultrasound Med. The US follow-up is mainly recommended for the smaller TR3 and TR4 nodules, and the prevalence of thyroid cancer in these groups in a real-world population with overall cancer risk of 5% is low, likely<3%. To further enhance the performance of TIRADS, we presume that patients present with only 1 TR category of thyroid nodules. Clipboard, Search History, and several other advanced features are temporarily unavailable. TIRADS Management Guidelines in the Investigation of Thyroid Nodules; Illustrating the Concerns, Costs, and Performance TIRADS Management Guidelines in the Investigation of Thyroid Nodules; Illustrating the Concerns, Costs, and Performance J Endocr Soc. Horvath E, Majlis S, Rossi R et-al. I have some serious news about my thyroid nodules today. 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%. 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. There remains the need for a highly performing diagnostic modality for clinically important thyroid cancers. There are two suspicious signs with the nodule (solid and irregular margin) and it was defined as C-TIRADS 4b. Its not something that happens every day, but every day. The common first step when you have a thyroid nodule is to go to your health care provider and get a referral. Haymart MR, Banerjee M, Reyes-Gastelum D, Caoili E, Norton EC. Become a Gold Supporter and see no third-party ads. 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. Data Set Used for Development of ACR TIRADS [16] and Used for This Paper The possible cancer rate column is a crude, unvalidated estimate, calculated by proportionately reducing the cancer rates by 10.3%: 5% to reflect the likely difference in the cancer rate in the data set used (10.3%) and in the population presenting with a thyroid nodule (5%). 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. A thyroid nodule is an unusual lump (growth) of cells on your thyroid gland. What does highly suspicious thyroid nodule mean? Results: But the test that really lets you see a nodule up close is a CT scan. 2021 Dec 7;101(45):3748-3753. doi: 10.3760/cma.j.cn112137-20210401-00799. 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 cost-effective diagnosis or exclusion of consequential thyroid cancer is an everyday problem faced by all thyroid clinicians. Bookshelf The prevalence of incidental thyroid cancer at autopsy is around 10% [3]. It is important to validate this classification in different centres. The cost of seeing 100 patients and only doing FNA on TR5 is at least NZ$100,000 (compared with $60,000 for seeing all patients and randomly doing FNA on 1 in 10 patients), so being at least NZ$20,000 per cancer found if the prevalence of thyroid cancer in the population is 5% [25]. Outlook. 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%). 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 clinical comparator of a group in which 1 in 10 nodules were randomly selected for FNA. The ACR TIRADS management flowchart also does not take into account these clinical factors. These cutoffs are somewhat arbitrary, with conflicting data as to what degree, if any, size is a discriminatory factor. Data Availability: All data generated or analyzed during this study are included in this published article or in the data repositories listed in References. The diagnosis or exclusion of thyroid cancer is hugely challenging. J Med Imaging Radiat Oncol (2009) 53(2):17787. The test that really lets you see a nodule up close is a CT scan. Those working in this field would gratefully welcome a diagnostic modality that can improve the current uncertainty. So just using ACR TIRADS as a rule-out test could be expected to leave 99% of undiagnosed cancers amongst the remaining 75% of the population, in whom the investigation and management remains unresolved. As a result, were left looking like a complete idiot with the results. The ROC curves of C-TIRADS, CEUS, and CEUS-TIRADS of 100 nodules in the validation cohort. Thus, the absolute risk of missing important cancer goes from 4.5% to 2.5%, so NNS=100/2=50. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). A proposal for a thyroid imaging reporting and data system for ultrasound features of thyroid carcinoma. Cheng H, Zhuo SS, Rong X, Qi TY, Sun HG, Xiao X, Zhang W, Cao HY, Zhu LH, Wang L. Int J Endocrinol. However, in the data set, only 25% of all nodules were categorized as TR1 or TR2 and these nodules harbored only 1% of all thyroid cancers (9 of 343). The difference was statistically significant (P<0.05). Jin Z, Zhu Y, Lei Y, Yu X, Jiang N, Gao Y, Cao J. Med Sci Monit. doi: 10.1210/jendso/bvaa031. 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. If a clinician does no tests and no FNAs, then he or she will miss all thyroid cancers (5 people per 100). Thyroid nodules are a common finding, especially in iodine-deficient regions. For every 100 FNAs performed, about 30 are inconclusive, with most (eg, 20% of the original 100) remaining indeterminate after repeat FNA and requiring diagnostic hemithyroidectomy. 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. The probability of malignancy was based on an equation derived from 12 features 2. Unauthorized use of these marks is strictly prohibited. Thyroid Nodules. 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%). So, the number needed to scan (NNS) for each additional person correctly reassured is 100 (NNS=100). Dr. Ron Karni, Chief of the Division of Head and Neck Surgical Oncology at McGovern Medical School at UTHealth Houston discusses Thyroid Nodules. 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. eCollection 2022. in 2009 1. Your email address will not be published. Using TR5 as a rule-in test was similar to random selection (specificity 89% vs 90%). A subdivision into 4a (malignancy between 5 and 10%) and 4b (malignancy between 10 and 80%) was optional. 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). 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. The specificity of TIRADS is high (89%) but, perhaps surprisingly, is similar to randomly selecting of 1 in 10 nodules for FNA (90%). In CEUS analysis, it reflected as later arrival time, hypo-enhancement, heterogeneous and centripetal enhancement, getting a score of 4 in the CEUS model. This study has many limitations. Using TIRADS as a rule-out cancer test would be the finding that a nodule is TR1 or TR2 and hence has a low risk of cancer, compared with being TR3-5. Using TR1 and TR2 as a rule-out test had excellent sensitivity (97%), but for every additional person that ACR-TIRADS correctly reassures, this requires >100 ultrasound scans, resulting in 6 unnecessary operations and significant financial cost. spiker54. 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. That particular test is covered by insurance and is relatively cheap. Cystic or almost completely cystic 0 points. The health benefit from this is debatable and the financial costs significant. 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. To develop a medical test a typical process is to generate a hypothesis from which a prototype is produced. If the nodule got a score of 2 in the CEUS schedule, the CEUS-TIRADS category remained the same as before. Methods: Thyroid nodules (566) subclassified as ACR-TIRADS 3 or 4 were divided into three size categories according to American Thyroid Association guidelines. These figures cannot be known for any population until a real-world validation study has been performed on that population. Thyroid nodules could be classified into one of 10 ultrasound patterns, which had a corresponding TI-RADS category. However, there are ethical issues with this, as well as the problem of overdiagnosis of small clinically inconsequential thyroid cancer. (2017) Radiology. 7. Any test will struggle to outperform educated guessing to rule out clinically important thyroid cancer. Chinese thyroid imaging reporting and data system(C-TIRADS); contrast-enhanced ultrasound (CEUS); differentiation; thyroid nodules; ultrasound (US). When it reflected an absent enhancement in CEUS, the nodule was judged as CEUS-TIRADS 3. National Library of Medicine 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 ). Federal government websites often end in .gov or .mil. 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. EU-TIRADS 1 category refers to a US examination where no thyroid nodule is found; there is no need for FNAB. 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. no financial relationships to ineligible companies to disclose. The pathological result was Hashimotos thyroiditis. 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. Search for other works by this author on: University of Otago, Christchurch School of Medicine, Department of Endocrinology, St Vincents University Hospital, Department of Radiology, St Vincents University Hospital, Dublin 4 and University College Dublin, Biostatistician, Department of Medical & Womens Business Management, Canterbury District Health Board, Thyroid incidentalomas: management approaches to nonpalpable nodules discovered incidentally on thyroid imaging, The prevalence of thyroid nodules and an analysis of related lifestyle factors in Beijing communities, Prevalence of differentiated thyroid cancer in autopsy studies over six decades: a meta-analysis, Occult papillary carcinoma of the thyroid. Of note, we have not taken into account any of the benefits, costs, or harms associated with the proposed US follow-up of nodules, as recommended by ACR-TIRADS. Given that a proportion of thyroid cancers are clinically inconsequential, the challenge is finding a test that can effectively rule-in or rule-out important thyroid cancer (ie, those cancers that will go on to cause morbidity or mortality). 24;8 (10): e77927. It is interesting to see the wealth of data used to support TIRADS as being an effective and validated tool. -, Zhou J, Yin L, Wei X, Zhang S, Song Y, Luo B, et al. Performing FNA on TR5 nodules is a relatively effective way of finding thyroid cancers. A 38-year-old woman with a nodule in the right-lobe of her thyroid gland. In CEUS analysis, it reflected as equal arrival time, iso-enhancement, homogeneity, and diffuse enhancement, receiving a score of 0 in the CEUS model. 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. Bastin S, Bolland MJ, Croxson MS. Role of Ultrasound in the Assessment of Nodular Thyroid Disease. doi: 10.1007/s12020-020-02441-y A newer alternative that the doctor can use to treat benign nodules in an office setting is called radiofrequency ablation (RFA). ", the doctor would like to answer as follows: With the information you provided, you have a homophonic nucleus in the right lobe. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 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. 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. The frequency of different Bethesda categories in each size range . This site needs JavaScript to work properly. -, Fresilli D, David E, Pacini P, Del Gaudio G, Dolcetti V, Lucarelli GT, et al. 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. Eur. 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). The gender bias (92% female) and cancer prevalence (10%) of the data set suggests it may not accurately reflect the intended test population. ADVERTISEMENT: Radiopaedia is free thanks to our supporters and advertisers. The more carefully one looks for incidental asymptomatic thyroid cancers at autopsy, the more are found [4], but these do not cause unwellness during life and so there is likely to be no health benefit in diagnosing them antemortem. TIRADS 4: suspicious nodules (5-80% malignancy rate). Write for us: What are investigative articles. It is limited by only being an illustrative example that does not take clinical factors into account such as prior radiation exposure and clinical features. 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. The TIRADS reporting algorithm is a significant advance with clearly defined objective sonographic features that are simple to apply in practice. A minority of these nodules are cancers. 1 Most thyroid nodules are detected incidentally when imaging is performed for another indication. 19 (11): 1257-64. Depending on the constellation or number of suspicious ultrasound features, a fine-needle biopsy is . TI-RADS 1: normal thyroid gland TI-RADS 2: benign nodule TI-RADS 3: highly probable benign nodule TI-RADS 4a: low suspicion for malignancy TI-RADS 4b: high suspicion for malignancy TI-RADS 5: malignant nodule with more than two criteria of high suspicion Imaging features TI-RADS 2 category Constantly benign patterns include simple cyst 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. Some cancers would not show suspicious changes thus US features would be falsely reassuring. This assumption is obviously not valid and favors TIRADS management guidelines, but we believe it is helpful for clarity and illustrative purposes. 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. 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. Please enable it to take advantage of the complete set of features! 2022 Jul;41(7):1753-1761. doi: 10.1002/jum.15858. Im on a treatment plan with my oncologist, my doctor, and Im about to start my next round of treatments. And because thyroid cancer is often diagnosed in a persons late 30s or 40s, most of us are often diagnosed after the symptoms have already begun. Other similar systems are in use internationally (eg, Korean-TIRADS [14] and EU-TIRADS [15]). Objectives: and transmitted securely. Other limitations include the various assumptions we have made and that we applied ACR TIRADS to the same data set upon which is was developed. K-TIRADS category was assigned to the thyroid nodules. This is a specialist doctor who specializes in the treatment and diagnosis of thyroid cancer. There are even data showing a negative correlation between size and malignancy [23]. With the right blood tests, you can see if you have a thyroid nodule, and if so, you can treat it with radioactive iodine. Here at the University of Florida, we are currently recruiting endocrinologists to work with us to help people with thyroid nodules. TI-RADS 1: Normal thyroid gland. Cibas ES, Ali SZ; NCI Thyroid FNA State of the Science Conference. 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. (2009) Thyroid : official journal of the American Thyroid Association. They will want to know what to do with your nodule and what tests to take. HHS Vulnerability Disclosure, Help 5 The modified TI-RADS was composed of seven ultrasound features in identifying benign and malignant thyroid nodules, such as the nodular texture, nodular Russ G, Royer B, Bigorgne C et-al. 2022 Jan 6;2022:5623919. doi: 10.1155/2022/5623919. To establish a contrast-enhanced ultrasound (CEUS) diagnostic schedule by CEUS analysis of thyroid nodules of C-TIRADS 4. Now, the first step in T3N treatment is usually a blood test. We aimed to assess the performance and costs of the American College of Radiology Thyroid Image Reporting And Data System (ACR-TIRADS). 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. Prospective evaluation of thyroid imaging reporting and data system on 4550 nodules with and without elastography. In: Thyroid 26.1 (2016), pp. 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. 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. At the time the article was created Praveen Jha had no recorded disclosures. This paper has only examined the ACR TIRADS system, noting that other similar systems exist such as Korean TIRADS [14]and EU TIRADS [15]. . J. Endocrinol. 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. There are inherent problems with studies addressing the issue such as selection bias at referral centers and not all nodules having fine needle aspiration (FNA). Each variable is valued at 1 for the presence of the following and 0 otherwise: The above systems were difficult to apply clinically due to their complexity, leading Kwak et al. The category definitions were similar to BI-RADS, based on the risk of malignancy depending on the presence of suspicious ultrasound features: The following features were considered suspicious: The study included only nodules 1 cm in greatest dimension. Treatment of patients with the left lobe of the thyroid gland, tirads 3 In the case of thyroid nodules, there are further challenges. 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.