Study on comparison of various TIRADS-systems and their elements

Protocol synopsis

 

Welcome among the NODULE investigators. You are one of the 8 co-investigators chosen for his/her experience and willingness to contribute to this important research.

Hypothesis: TIRADS scores are highly observer dependent.

The aims of the study are

For the short description of TIRADS, please see the end of this document.

During the planning phase, the investigators who initiated the study (TS, LH and EN, referred to as core) decided on the individual cases (one nodule = one case) and the number of benign and malignant nodules to be included in the study. Each case is a video recording of the ultrasound examination of a nodule (TS). There may be several nodules of the same patient's thyroid gland (presented as separate cases). A Case Report Form (CRF) accompanies each case. It contains questions with responses offered; these responses come from the TIRADS systems. Based on your answers, the 4 different TIRADS scores will be calculated by the computer program. A short patient history is also shown, with the most relevant patient data, typical of those what you are aware of during a usual ultrasound examination. However, it is up to you if you read the patient data as the ultrasound character of a nodule is independent of this information.

The number of the cases in NODULE is 123. The minimum number of cases (nodules) needed for comparison and for obtaining a descriptive kappa value has been calculated by ZK (our statistician) based on 100 computer simulations (6 investigators and different misinterpretation ratios in each run) and was found to be at least 100.

To estimate intraobserver variation, you will be asked for a repeated analysis of the cases 4 weeks after completion of the first series.

Please evaluate the 6 training cases. These nodules will not be part of the actual study. If interrupted, you may return and continue later. Click ‘submit' when done. We would appreciate your comments when you are done. Please e-mail your comments to solymosi@thyrosite.com. Such comments and suggestions will be discussed by the core investigators and thereafter shared with all participants.

Please perform the above tasks ASAP, and with an ultimate deadline of Feb. 26th. The study cases will be available to you after all comments have been obtained, managed appropriately and led to a final protocol.

Please go to the website of the NODULE study and read the 3 short (one page each) help documents behind the blue buttons on the left. Following this, please evaluate the 6 training cases, which will not be part of the actual study. You can find a link in the invitation e-mail. By clicking on this link you can start the review of the 6 sample cases.

Important. The responses you entered into the CRF will not be published or shared with the other investigators, or anybody else either during the training phase or after completing the investigation. Data will be used only for statistical analysis. Any type of communication which could link an investigator's responses to his or her name will be avoided. You, as an investigator may request access to the final already closed database, including final histology, once the investigation has been completed. You will have a chance to compare your responses to the other 7 investigators'; however, the identities of the other 7 investigators will be blinded in this table. We may opt to make accessible the 123 cases on the web for training purposes after publication of the data. For this, the same identity protection rules apply.

For the evaluation of the study cases, 8 weeks will be provided. Another 8 weeks will be given to reevaluate the cases 4-6 weeks later (intraobserver variation).

We are confident that it will be a pleasure to collaborate with you on this challenging project.

 

Best regards

 

Tamas Solymosi

Laszlo Hegedus

Endre V. Nagy

The 4 scoring systems

 

AACE/ACE-AME

1.Low-risk lesion

• Cysts (fluid component > 80%)
• Mostly cystic nodules with reverberating artifacts and not associated with suspicious US signs
• Isoechoic spongiform nodules iether confluent or with regular halo

2 Intermediate-risk lesion

Slightly hypoechoic or isoechoic nodules, with ovoid shape, smooth or ill-defined margins.
May be present:

• intranodular vascularization
• elevated stiffnes at elastography
• macro or continuous rim calcifications
• indeterminate hyperechoic spots

3 High-risk lesion

Nodules with at least 1 of the following features:

• Marked hypoechogenicity
• Spiculated or lobulated margins
• Microcalcifications

• Taller-than wide shape
• Extrathyroidal growth
• Pathological adenopathy

 

ATA

Benign

Purely cystic nodules (no solid component)

Very low suspicion

Spongiform or partially cystic nodules without any of the features describes in low-, intermediate- or high-suspicion patterns

Low suspicion

Isoechoic or hyperechoic solid nodule, or partially cystic nodule with eccentric solid area without:

•  Microcalcification

•  Irregular margin

•  Extrathyroidal extension

•  Taller than wide shape

Intermediate suspicion

Hypoechoic solid nodule with smooth margins without:

•  Microcalcification

•  Extrathyroidal extension

•  Or taller than wide shape

High suspicion

Solid hypoechoic nodule or solid hypoechoic component of partially cystic nodule with 1 or more of the following features:

•  Irregular margins (infiltrative, microlobulated)

•  Microcalcifications

•  Taller than wide shape

•  RIm calcifications with extrusive soft tissue component

•  Evidence of extrathyroidal extension

 

EU-TIRADS

 

1: normal:

No nodules

2: benign:

Pure cyst

Entirely spongiform

3: low risk:

ovoid, smooth isoechoic/hyperechoic

No features of high suspicion

4: intermediate risk:

ovoid, smooth mildly hypoechogenic

No features of high suspicion

5: high risk:

At least one of the following features of high suspicion:

•  irregular shape

•  irregular margins

•  microcalcifications

•  marked hypoechogenicity (and solid)

ACR TI-RADS