Study on comparison of various TIRADS-systems and their elements
How to do it?
Please analyze the video recordings of the ultrasound examinations of 123 thyroid lesions found in 101 patients. One nodule = one case. The cases are presented separately in random order. Each case (nodule) is accompanied by a Case Report Form (CRF). Please answer each of the 17 questions in the Form. Under the last item, you are given the possibility to write comments to the case in question. This is optional. Please leave this space blank unless you have specific notes related to the ultrasound features of that nodule.
At preparation of the NODULE series, core members (Tamas Solymosi, Laszlo Hegedus, Endre V. Nagy) divided nodules operated on into two sets based on final histolology. Set 1 cases are benign lesions (including the nodule in question, if there were more than one nodule), and Set 2 cases, which are malignant. To be able to do this, the video recordings of thyroid ultrasound examinations of more than 5000 consecutively investigated patients were used. Also, both case sets are consecutive in their respective category, ie. benign or malignant. This categorization allowed us to arbitrarily adjust the percentage of malignant cases to a pre-defined value which will only be disclosed on the completion of the investigation part of the study. Benign and malignant cases are presented randomly. Further, each investigator will see the cases in different, random order. This will be mentioned in any manuscript to facilitate publication. The case numbers found on the video recordings serve ID purposes and are not in the order of presentation to you.
Relevant clinical data known to the ultrasound examiner/recorder (TS) at the time of examination are available for orientation purposes next to each video recording. It is up to you if you wish to utilize this information. FNA results are not included. However, the NODULE study examines ultrasound characteristics, which are hardly influenced by clinical data.
The characteristics in question rely on various properties of the lesions which are essential to group the nodules according to the TIRADS systems of different professional societies: ETA, ATA, ACR, and AACE/ACE-AME. You do not need to (should not) calculate the different TIRADS scores of the lesions. All parameters to generate the scores are provided when the CRF is complete, at which time the calculations will be performed by a computer program when all the investigators' responses have been obtained. Four additional parameters, which are less investigator-dependent (the diameters of the lesion, taller than wide shape, presence or absence of pathologic neck lymph nodes, and presence or absence of intranodular blood flow) are judged by TS and are pre-recorded into the CRF of each patient. You are welcome to check this info.
On examining a case you have the opportunity to enlarge the video, to review in slow motion or repeat the review before answering the questions (see also: Technical help).
Initially, you are provided with 6 „training” cases similar to the study cases. These cases are not included in the actual study. If you have questions, including technical ones, please e-mail them to T.Solymosi. All questions arising during the introductory phase will be shared with the other investigators. This also applies to questions during the investigation phase.
Laszlo Hegedűs
Zsolt Karanyi
Endre V.Nagy
