Radiographic features Ultrasound 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). Lin JD, Chao TC, Huang BY, Chen ST, Chang HY, Hsueh C. Bongiovanni M, Crippa S, Baloch Z, et al. Full data including 95% confidence intervals are given elsewhere [25]. The risk of malignancy was derived from thyroid ultrasound (TUS) features. 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. The cost-effective diagnosis or exclusion of consequential thyroid cancer is an everyday problem faced by all thyroid clinicians. 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. In response, ACR committees were formed to accomplish three goals: License Information A negative result with a highly sensitive test is valuable for ruling out the disease. PLoS ONE. 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. https://www.uptodate.com/contents/search. Background Thyroid cancer diagnosis has evolved to include computer-aided diagnosis (CAD) approaches to overcome the limitations of human ultrasound feature assessment. Feeling tired more easily. Produce a lexicon to describe all thyroid nodules on sonography. 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. 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. This may include: Treatment for a nodule that's cancerous usually involves surgery. 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 get the most from your appointment, try these suggestions: Mayo Clinic does not endorse companies or products. 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. 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. 26th ed. It is interesting to see the wealth of data used to support TIRADS as being an effective and validated tool. Its simple: Most people treated with RFA are back to their normal activities the next day with no problems. 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. Therefore, taking results from this data set and assuming they would apply to the real-world population raises concerns. 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. After a median follow-up of 36.1 months, a volumetric increase 50% occurred in 28 . Thyroid gland. 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. 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. However, a thyroid scan can't distinguish between cold nodules that are cancerous and those that aren't cancerous. 2020 Mar 10;4 (4):bvaa031. 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]). There are a number of additional issues that should be taken into account when examining the ACR TIRADS data set and resultant management recommendations. Sometimes, your doctor detects a thyroid nodule when you have an imaging test, such as an ultrasound, CT or MRI scan, to evaluate another condition in your head or neck. The system is sometimes referred to as TI-RADS French 6. A single copy of these materials may be reprinted for noncommercial personal use only. Haymart MR, Banerjee M, Reyes-Gastelum D, Caoili E, Norton EC. 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]. 2016; doi:10.1038/nrendo.2016.110. As noted previously, we intentionally chose the clinical comparator to be relatively poor and not a fair reflection of real-world practice, to make it clearer to what degree ACR TIRADS adds value. 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). Reston, VA 20191 Overview of thyroid nodule formation. The system has fair interobserver agreement 4. Park JY, Lee HJ, Jang HW, Kim HK, Yi JH, Lee W, Kim SH. Thyroid Imaging Reporting & Data System (TI-RADS) Thyroid nodules are exceedingly common, leading to costly interventions for many lesions that ultimately prove benign. 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. Washington, DC 20004 Dry skin. Diagnosis and Management of Small Thyroid Nodules: A Comparative Study with Six Guidelines for Thyroid Nodules. 2013;168 (5): 649-55. 6. 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%. 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). Tom James Cawood, Georgia Rose Mackay, Penny Jane Hunt, Donal OShea, Stephen Skehan, Yi Ma, TIRADS Management Guidelines in the Investigation of Thyroid Nodules; Illustrating the Concerns, Costs, and Performance, Journal of the Endocrine Society, Volume 4, Issue 4, April 2020, bvaa031, https://doi.org/10.1210/jendso/bvaa031. Ultrasound can help evaluate a thyroid nodule and determine the need for biopsy. According to the modified TI-RADS, individuals with thyroid nodules graded 1-3 were identified as the low-risk group of thyroid cancer, while individuals graded 4a-6 were identified as the high-risk group of thyroid cancer. The present study evaluated the risk of malignancy in solid nodules>1 cm using ACR TI-RADS. If a biopsy shows that you have a noncancerous thyroid nodule, your doctor may suggest simply watching your condition. It is this proportion of patients that often go on to diagnostic hemithyroidectomies, from which approximately 20% are cancers [12, 17, 21], meaning the majority (80%) end up with ultimately unnecessary operations. In ACR TI-RADS, points in five feature categories are summed to determine a risk level from TR1 to TR5 . 215-574-3150, 1100 Wayne Ave., Suite 1020 Some are solid, and some are fluid-filled cysts. Nervousness or irritability. 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]. 3 However, they are found incidentally in up to 40% of patients who undergo ultrasonography of the neck, 4 and in 36% to 50% of persons at . Recently, the American College of Radiology (ACR) proposed a Thyroid Imaging Reporting and Data System (TI-RADS) for thyroid nodules based on ultrasonographic features. 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. 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. doi: 10.1210/jendso/bvaa031. 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). 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 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 diagnostic accuracy. 4. Make a donation. 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]). 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. TIRADS 3 nodule is a thyroid nodule that is mildly suspicious based on ultrasound findings. This usually means having a physical exam and thyroid function tests at regular intervals. Thyroid scan. In 2013, Russ et al. 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. Thyroid imaging reporting and data system for US features of nodules: a step in establishing better stratification of cancer risk. What is TIRADS 3 nodule? 4b - Suspicious nodules (10-50% risk of malignancy) Score of 2. Tessler F, Middleton W, Grant E. Thyroid Imaging Reporting and Data System (TI-RADS): A Users Guide. Routine FNA of this group is more likely to lead to false positive . 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. 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. A meta-analysis, This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (, Mitoguardin2 is Associated with Hyperandrogenism and Regulates Steroidogenesis in Human Ovarian Granulosa Cells, Factors Associated with Diabetes Distress among Patients with Poorly Controlled Type 2 Diabetes, Serum adiponectin and leptin is not related to skeletal muscle morphology and function in young women, Association Between Metabolic Syndrome Inflammatory Biomarkers and COVID-19 Severity, Long-term outcome of body composition, ectopic lipid and insulin resistance changes with surgical treatment of acromegaly, Volume 7, Issue 4, April 2023 (In Progress), The Journal of Clinical Endocrinology & Metabolism, https://www.uptodate.com/contents/diagnostic-approach-to-and-treatment-of-thyroid-nodules, https://doi.org/10.6084/m9.figshare.11640168.v, http://creativecommons.org/licenses/by-nc-nd/4.0/, Receive exclusive offers and updates from Oxford Academic, 1 in 10 nodules having FNA, assuming pretest probability of cancer of 5%, Negative test being TR1 or TR2; positive test meaning TR3, TR4, or TR5, Positive test meaning TR5; negative test meaning TR1-4, Positive test meaning TR5, TR4 above size cutoff and TR3 above size cutoff; negative test meaning TR1, TR2, TR3 Below Size Cutoff or TR4 below size cutoff, Positive Test Meaning TR5, TR4 Above Size Cutoff and TR3 Above Size Cutoff; negative test meaning TR1, TR2, TR3 below size threshold or TR4 below size cutoff. 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. Nature Reviews Endocrinology. All thyroid nodules were scored with the French TIRADS flowchart, already described by our team ( 1, 10 ). 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. A radioactive iodine scan uses a radioactive form of iodine and a special camera to detect thyroid cancer cells in your body. We assessed a hypothetical clinical comparator where 1 in 10 nodules are randomly selected for fine needle aspiration (FNA), assuming a pretest probability of clinically important thyroid cancer of 5%. Your doctor will also look for signs and symptoms of hyperthyroidism, such as tremor, overly active reflexes, and a rapid or irregular heartbeat. The specificity of TIRADS is high (89%) but, perhaps surprisingly, is similar to randomly selecting of 1 in 10 nodules for FNA (90%). If it performs well enough, then the test is applied to a training set of data to better establish performance characteristics. https://www.thyroid.org/hypothyroidism/. If a doctor suspects that a thyroid nodule may . You then lie on a table while a special camera produces an image of your thyroid on a computer screen. Ross DS. 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. For this, we do take into account the nodule size cutoffs but note that for the TR3 and TR4 categories, ACR TIRADS does not detail how it chose the size cutoffs of 2.5 cm and 1.5 cm, respectively. These cutoffs are somewhat arbitrary, with conflicting data as to what degree, if any, size is a discriminatory factor. Silver Spring, MD 20910 Thyroid nodules. To develop a medical test a typical process is to generate a hypothesis from which a prototype is produced. 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. In other cases, the nodules can get big enough to cause problems. The system has fair interobserver agreement 4. Accessed Nov. 7, 2019. Castellana M, Castellana C, Treglia G, Giorgino F, Giovanella L, Russ G, Trimboli P. Oxford University Press is a department of the University of Oxford. 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. The score for this nodule is 3 points. 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%. 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. TIRADS does not perform to this high standard. Ross DS. These publications erroneously add weight to the belief that TIRADS is a proven and superior model for the investigation of thyroid nodules. 2 However, today more limited surgery to remove only half of the thyroid may be appropriate for some cancerous nodules. 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. Some patients are good candidates for a scarless thyroid procedure, where the surgeon reaches the thyroid through an incision made on the inside of your lower lip. The chance of finding a consequential thyroid cancer during follow-up is correspondingly low. Anderson TJ, Atalay MK, Grand DJ, Baird GL, Cronan JJ, Beland MD. 7. 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. TI-RADS 1: Normal thyroid gland. They are found . The gold test standard would need to be applied for comparison. Develop a standardized TI-RADS risk-stratification system based on the lexicon to inform practitioners about which nodules warrant biopsy. Even a benign growth on your thyroid gland can cause symptoms. Thyroid imaging reporting and data system (TI-RADS). Whilst our findings have illustrated some of the shortcomings of ACR TIRADS guidelines, we are not able to provide the ideal alternative. 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. Radiology. TI-RADS 4b applies to the lesion with one or two of the above signs and no metastatic lymph node is present. 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]. ACR TIRADS performed poorly when applied across all 5 TR categories, with specificity lower than with random selection (63% vs 90%). Quite where the cutoff should be is debatable, but any cutoff below TR5 will have diminishing returns and increasing harms. 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). Nodules located in the thyroid isthmus are at greater risk of being malignant than those found in the lateral lobes, whereas those in the lower portion of the lobes are at least risk. Thyroid nodules are common, affecting around one-half of the population and become increasingly common with advancing age [1, 2]. Even a benign growth on your thyroid gland can cause symptoms. Thyroid. TI-RADS categories Composition Cyst Spongiform Mixed cystic/solid Solid lesions Echogenicity Shape Margin Echogenic foci Attempts to compare the different TIRADS systems on data sets that are also not reflective of the intended test population are similarly flawed (eg, malignancy rates of 41% [29]). 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. We aimed to assess the performance and costs of the American College of Radiology Thyroid Image Reporting And Data System (ACR-TIRADS).
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