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THYROID
Volume 26, Number 1, 2016
ª American Thyroid Association
ª Mary Ann Liebert, Inc. DOI: 10.1089/thy.2015.0020
SPECIAL ARTICLE | 0 |
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 | 2 |
Bryan R. Haugen,1,* Erik K. Alexander,2 Keith C. Bible,3 Gerard M. Doherty,4 Susan J. Mandel,5 Yuri E. Nikiforov,6 Furio Pacini,7 Gregory W. Randolph,8 Anna M. Sawka,9 Martin Schlumberger,10 Kathryn G. Schuff,11 Steven I. Sherman,12 Julie Ann Sosa,13 David L. Steward,14
R. Michael Tuttle,15 and Leonard Wartofsky16 | 3 |
Background: Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association’s (ATA’s) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of ... | 5 |
1University of Colorado School of Medicine, Aurora, Colorado.
2Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts.
3The Mayo Clinic, Rochester, Minnesota.
4Boston Medical Center, Boston, Massachusetts.
5Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
6Univer... | 6 |
of differentiated thyroid cancer include those related to surveillance for recurrent disease using imaging and serum thyroglobulin, thyroid hormone therapy, management of recurrent and metastatic disease, consideration for clinical trials and targeted therapy, as well as directions for future research.
Conclusions: We ... | 8 |
INTRODUCTION
also present important clinical challenges in many clinical practice settings. | 11 |
Thyroid nodules are a common clinical problem. | 12 |
Epidemiologic studies have shown the prevalence of
palpable thyroid nodules to be approximately 5% in women and 1% in men living in iodine-sufficient parts of the world (1,2). In contrast, high-resolution ultrasound (US) can detect thyroid nodules in 19%–68% of randomly selected individ- uals, with higher frequencies i... | 13 |
Table 1. Interpretation of the American College of Physicians’ Guideline Grading System (for Therapeutic Interventions)
Recommendation Clarity of risk/benefit Implications | 14 |
Strong recommendation Benefits clearly outweigh
harms and burdens, or vice versa. | 15 |
Weak recommendation Benefits closely balanced
with harms and burdens. | 16 |
No recommendation Balance of benefits and
risks cannot be determined.
Patients: Most would want course of action; a person should request discussion if an intervention is not offered.
Clinicians: Most patients should receive the recommended course of action.
Policymakers: The recommendation can be adopted as policy in ... | 18 |
have recently revised guidelines on treatment of patients with thyroid tumors (23). Given the existing controversies in the field, differences in critical appraisal approaches for existing evidence, and differences in clinical practice patterns across geographic regions and physician specialties, it should not be surpr... | 21 |
METHODS
ATA Thyroid Nodules and Differentiated Thyroid Cancer guidelines were published in 2006 (24) and revised in 2009
(25). Because of the rapid growth of the literature on this topic, plans for revising the guidelines within approximately 4 years of publication were made at the inception of the project. A task forc... | 22 |
Table 2. Recommendations (for Therapeutic Interventions) Based on Strength of Evidence
Recommendation
and evidence quality Description of supporting evidencea Interpretation
Strong recommendation | 23 |
High-quality evidence RCT without important limitations
or overwhelming evidence from observational studies
Moderate-quality evidence RCT with important limitations
or strong evidence from observational studies
Can apply to most patients in most circumstances without reservation | 24 |
Can apply to most patients in most circumstances without reservation | 25 |
Low-quality evidence Observational studies/case studies May change when higher-quality
evidence becomes available | 26 |
Weak recommendation
High-quality evidence RCT without important limitations
or overwhelming evidence from observational studies
Moderate-quality evidence RCT with important limitations
or strong evidence from observational studies | 27 |
Best action may differ based on circumstances or patients’ values | 28 |
Best action may differ based on circumstances or patients’ values | 29 |
Low-quality evidence Observational studies/case studies Other alternatives may be equally
reasonable | 30 |
Insufficient Evidence is conflicting, of poor quality, or lacking
Insufficient evidence to recommend for or against | 31 |
aThis description of supporting evidence refers to therapy, therapeutic strategy, or prevention studies. The description of supporting evidence is different for diagnostic accuracy studies.
RCT, randomized controlled trial. | 33 |
Table 3. Interpretation of the American Thyroid Association Guideline Grading System for Diagnostic Tests
Accuracy of diagnostic information versus risks | 34 |
Recommendation
and burden of testinga Implications | 35 |
Strong
recommendation | 36 |
Weak
recommendation
Knowledge of the diagnostic test result clearly outweighs risks and burden of testing or vice versa. | 45 |
Knowledge of the diagnostic test result is closely balanced
with risks and burden of testing.
Patients: In the case of an accurate test for which benefits outweigh risks/burden, most would want the diagnostic to be offered (with appropriate counseling). A patient should request discussion of the test if it is not offer... | 53 |
No recommendation Balance of knowledge of the
diagnostic test result cannot be determined.
Decisions on the use of the test based on evidence from scientific studies cannot be made. | 54 |
aFrequently in these guidelines, the accuracy of the diagnosis of thyroid cancer (relative to a histologic gold standard) was the diagnostic outcome unless otherwise specified. However, prognostic, disease staging, or risk stratification studies were also included in the grading scheme of diagnostic studies. For diseas... | 56 |
for use in these guidelines, relating to critical appraisal and recommendations on therapeutic interventions (26) (Tables 1 and 2). An important component of these guidelines was judged to be critical appraisal of studies of diagnostic tests; however, the ACP Guideline Grading System is not designed for this purpose. W... | 57 |
Table 4. Recommendations (for Diagnostic Interventions) Based on Strength of Evidence
Recommendation and
evidence quality Methodologic quality of supporting evidence Interpretation
Strong recommendation | 58 |
High-quality evidence Evidence from one or more well-designed
nonrandomized diagnostic accuracy studies (i.e., observational—cross-sectional or cohort) or systematic reviews/meta-analyses of such observational studies (with no concern about internal validity or external generalizability
of the results)
Moderate-quality... | 59 |
Weak recommendation
High-quality evidence Evidence from one or more well-designed nonrando-
mized diagnostic accuracy studies
(i.e., observational—cross-sectional or cohort) or systematic reviews/meta-analyses of such ob-
servational studies (with no concern about internal validity or external generalizability of the r... | 60 |
Low-quality evidence Evidence from nonrandomized diagnostic accuracy
studies with one or more important limitations causing serious concern about internal validity or external generalizability of the results.
Insufficient Evidence may be of such poor quality, conflicting, lacking (i.e., studies not done), or not extern... | 61 |
Implies the test can be offered to most patients in most applicable circumstances without reservation. | 62 |
Implies the test can be offered to most patients in most applicable circumstances, but the utilization of the test may change when higher-quality evidence becomes available. | 63 |
The degree to which the di- agnostic test is seriously considered may differ de- pending on circumstances or patients’ or societal values.
The degree to which the diag- nostic test is seriously con- sidered may differ depending on individual patients’/ practice circumstances or patients’ or societal values.
Alternative... | 64 |
Insufficient evidence exists to recommend for or against routinely offering the diag- nostic test. | 65 |
methodologic elements: consecutive recruitment of patients representative of clinical practice, use of an appropriate ref- erence gold standard, directness of evidence (e.g., target population of interest, testing procedures representative of clinical practice, and relevant outcomes), precision of diag- nostic accuracy... | 68 |
the accuracy in establishing a definitive diagnosis, largely relating to the diagnosis of new or recurrent malignancy (unless otherwise specified). Diagnostic tests or risk stratifi- cation systems used for estimation of prognosis were also appraised using the diagnostic test grading system. An im- portant limitation o... | 69 |
studies could be considered high-quality evidence; yet, a therapeutic strategy incorporating the use of the diagnostic test would require one or more well-executed randomized controlled trials (RCTs) to be considered high-quality evi- dence. In developing and applying our diagnostic test critical appraisal system, we c... | 71 |
Table 5. Organization of the 2015 ATA Guidelines for Thyroid Nodules and Differentiated Thyroid Cancer
Page Location key Sections and subsections Itema | 72 |
10 [A1] THYROID NODULE GUIDELINES | 73 |
10 [A2] What is the role of thyroid cancer screening in people with
R1b | 74 |
(continued) | 83 |
Page Location key Sections and subsections Itema | 85 |
FLUS, FN, SUSP)?b | 88 |
malignancyc | 92 |
parathyroid issues?b | 93 |
thyroidectomy samples?b
stratification in the management of DTC?
40 [B17] Postoperative staging R47
[B18] AJCC/UICC TNM staging T10 | 95 |
[B19] What initial stratification system should be used to estimate
the risk of persistent/recurrent disease?c
[B20] Potential impact of specific clinico-pathologic features on the risk
estimates in PTCb
[B21] Potential impact of BRAFV600E and other mutations on risk of
estimates in PTCb
[B22] Potential impact of posto... | 96 |
46 [B24] Risk of recurrence as a continuum of riskb F4b
[B25] How should initial risk estimates be modified over time?b R49
[B26] Proposed terminology to classify response to therapy and clinical | 99 |
(continued) | 101 |
Table 5. (Continued)
Page Location key Sections and subsections Itema | 102 |
response)b | 106 |
ablation or adjuvant therapy?
64 [B43] Early management of DTC after initial therapy
[B44] What is the appropriate degree of initial TSH suppression? R59
[B45] Is there a role for adjunctive external beam radiation or
chemotherapy? | 115 |
decisionsb | 120 |
bisphosphonates) in treating metastatic DTC?c | 138 |
aF, figure; R, recommendation; T, table.
bNew section/recommendation.
cSubstantially changed recommendation compared with 2009.
ATA, American Thyroid Association; AUS/FLUS, atypia of undetermined significance/follicular lesion of undetermined significance; CT, computed tomography; DTC, differentiated thyroid cancer; FN... | 145 |
[A1] THYROID NODULE GUIDELINES
A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid pa- renchyma. Some palpable lesions may not correspond to distinct radiologic abnormalities (32). Such abnormalities do not meet the strict definition for thyroid no... | 147 |
[A2] What is the role of thyroid cancer screening in people with familial follicular cell–derived DTC? | 148 |
RECOMMENDATION 1
Screening people with familial follicular cell–derived DTC may lead to an earlier diagnosis of thyroid cancer, but the panel cannot recommend for or against US screening since there is no evidence that this would lead to reduced morbidity or mortality.
(No recommendation, Insufficient evidence)
Screeni... | 149 |
[A3] What is the appropriate laboratory and imaging evaluation for patients with clinically or incidentally discovered thyroid nodules?
[A4] Serum thyrotropin measurement | 150 |
RECOMMENDATION 2
Serum thyrotropin (TSH) should be measured during the initial evaluation of a patient with a thyroid nodule.
(Strong recommendation, Moderate-quality evidence)
If the serum TSH is subnormal, a radionuclide (pref- erably 123I) thyroid scan should be performed. (Strong recommendation, Moderate-quality e... | 151 |
With the discovery of a thyroid nodule, a complete history and physical examination focusing on the thyroid gland and adjacent cervical lymph nodes should be performed. Perti- nent historical factors predicting malignancy include a his- tory of childhood head and neck radiation therapy, total body radiation for bone ma... | 152 |
Pertinent physical findings suggesting possible malignancy include vocal cord paralysis, cervical lymphadenopathy, and fixation of the nodule to surrounding tissue.
With the discovery of a thyroid nodule >1 cm in any di- ameter, a serum TSH level should be obtained. If the serum TSH is subnormal, a radionuclide thyroid... | 154 |
[A5] Serum thyroglobulin measurement | 155 |
RECOMMENDATION 3
Routine measurement of serum thyroglobulin (Tg) for initial evaluation of thyroid nodules is not recommended.
(Strong recommendation, Moderate-quality evidence) | 156 |
Serum Tg levels can be elevated in most thyroid diseases and are an insensitive and nonspecific test for thyroid cancer (47–49). | 157 |
[A6] Serum calcitonin measurement | 158 |
RECOMMENDATION 4
The panel cannot recommend either for or against routine measurement of serum calcitonin in patients with thyroid nodules.
(No recommendation, Insufficient evidence) | 159 |
The utility of serum calcitonin has been evaluated in a series of prospective, nonrandomized studies (50–54). These data suggest that the use of routine serum calcitonin for screening may detect C-cell hyperplasia and MTC at an earlier stage, and overall survival consequently may be improved. However, most studies reli... | 160 |
[A7] [18F]Fluorodeoxyglucose positron emission tomography scan | 161 |
RECOMMENDATION 5
(A) Focal [18F]fluorodeoxyglucose positron emission to- mography (18FDG-PET) uptake within a sonographically confirmed thyroid nodule conveys an increased risk of thyroid cancer, and FNA is recommended for those nod- ules ‡1 cm.
(Strong recommendation, Moderate-quality evidence)
B) Diffuse 18FDG-PET up... | 162 |
18FDG-PET is increasingly performed during the evalua- tion of patients with both malignant and nonmalignant ill- ness. While 18FDG-PET imaging is not recommended for the
evaluation of patients with newly detected thyroid nodules
or thyroidal illness, the incidental detection of abnormal thyroid uptake may nonetheles... | 163 |
of Hashimoto’s disease or other diffuse thyroidal illness. However, if detected, diffuse 18FDG-PET uptake in the thyroid should also prompt sonographic examination to en- sure there is no evidence of clinically relevant nodularity. Most patients with diffuse 18FDG-PET uptake demonstrate diffuse heterogeneity on sonogra... | 165 |
[A8] Thyroid sonography | 166 |
RECOMMENDATION 6
Thyroid sonography with survey of the cervical lymph nodes should be performed in all patients with known or suspected thyroid nodules.
(Strong recommendation, High-quality evidence) | 167 |
Diagnostic thyroid/neck US should be performed in all patients with a suspected thyroid nodule, nodular goiter, or radiographic abnormality suggesting a thyroid nodule inci- dentally detected on another imaging study (e.g., computed tomography [CT] or magnetic resonance imaging [MRI] or thyroidal uptake on 18FDG-PET... | 168 |
[A9] US for FNA decision-making | 169 |
RECOMMENDATION 7
FNA is the procedure of choice in the evaluation of thyroid nodules, when clinically indicated.
(Strong recommendation, High-quality evidence)
FNA is the most accurate and cost-effective method for
evaluating thyroid nodules. Retrospective studies have reported
lower rates of both nondiagnostic and f... | 170 |
[A10] Recommendations for diagnostic FNA of a thyroid nodule based on sonographic pattern
Figure 1 provides an algorithm for evaluation and man-
agement of patients with thyroid nodules based on sono-
graphic pattern and FNA cytology, which is discussed in subsequent sections. | 171 |
RECOMMENDATION 8
Thyroid nodule diagnostic FNA is recommended for (Fig. 2, Table 6):
Nodules ‡1 cm in greatest dimension with high sus- picion sonographic pattern.
(Strong recommendation, Moderate-quality evidence)
Nodules ‡1 cm in greatest dimension with intermedi- ate suspicion sonographic pattern.
(Strong recommenda... | 172 |
Thyroid US has been widely used to stratify the risk of malignancy in thyroid nodules, and aid decision-making about whether FNA is indicated. Studies consistently report that several US gray scale features in multivariate analyses are associated with thyroid cancer, the majority of which are PTC. These include the ... | 173 |
FIG. 1. Algorithm for evaluation and management of patients with thyroid nodules based on US pattern and FNA cytology. R, recommendation in text. | 175 |
although the sensitivities are significantly lower for any single feature (70–77). It is important to note that poorly defined margins, meaning the sonographic interface between the nod- ule and the surrounding thyroid parenchyma is difficult to de- lineate, are not equivalent to irregular margins. An irregular margin ... | 176 |
FIG. 2. ATA nodule sonographic patterns and risk of malignancy. | 178 |
Table 6. Sonographic Patterns, Estimated Risk of Malignancy, and Fine-Needle Aspiration Guidance for Thyroid Nodules | 179 |
Sonographic pattern US features
Estimated risk of malignancy, %
FNA size cutoff (largest dimension) | 180 |
High suspicion Solid hypoechoic nodule or solid hypoechoic
component of a partially cystic nodule
with one or more of the following features:
irregular margins (infiltrative, microlobu- lated), microcalcifications, taller than wide
shape, rim calcifications with small extru- sive soft tissue component, evidence
of ET... | 181 |
10–20 Recommend FNA at ‡1 cm 5–10 Recommend FNA at ‡1.5 cm
<3 Consider FNA at ‡2 cm Observation without FNA is also a reasonable option | 183 |
Benign Purely cystic nodules (no solid component) <1 No biopsyb
US-guided FNA is recommended for cervical lymph nodes that are sonographically suspicious for thyroid cancer (see Table 7).
aThe estimate is derived from high volume centers, the overall risk of malignancy may be lower given the interobserver variability i... | 184 |
solid component and cyst, and the presence of micro- calcifications consistently confer a higher risk of malignancy (85–87). Other findings such as lobulated margins or increased vascularity of the solid portion are risk factors that are not as robust (86,87). However, a spongiform appearance of mixed
cystic solid nod... | 187 |
Intermediate suspicion [malignancy risk 10%–20% (89,90,94)]. Intermediate suspicion of malignancy is at- tached to a hypoechoic solid nodule with a smooth regular margin, but without microcalcifications, extrathyroidal ex- tension, or taller than wide shape (Fig. 2, Table 6). This appearance has the highest sensitivity... | 188 |
Table 7. Ultrasound Features of Lymph Nodes Predictive of Malignant Involvementa
overlap with other nodules in the anterioposterior plane. Obese patients, those with multinodular goiters and coalescent nod- | 190 |
Sign
Reported sensitivity, %
Reported specificity, %
ules, or patients in whom the nodule is posterior or inferior are not candidates for USE. Thus, at present, USE cannot be | 191 |
widely applied to all thyroid nodules in a similar fashion to | 192 |
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