Real time ultrasound elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer

Primary outcome measure as of 14/02/2017:
The proportion of patients who have a non-diagnostic (Thy1) cytology result following the first FNAC.

Original primary outcome measure:
The rate of benign histology result following thyroid surgery, compared between the RTE-FNAC arm and the conventional US-FNAC arm.

Secondary outcome measures as of 14/02/2017:
1. Number of FNACs required to obtain definitive diagnosis
2. Time from first FNAC to obtaining a definitive diagnosis
3. The proportion of patients with benign histology results following thyroidectomy
4. Proportion of patients who have thyroidectomy
5. Accuracy of a cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis;
6. Accuracy of an imaging assessment on ultrasound (with or without RTE) alone diagnostic protocol in relation to overall definitive diagnosis
7. Patient reported outcome measures of depression and anxiety, pain, and quality of life: the Hospital Anxiety and Depression rating scale (HADS), Visual Analogue Pain Score (VAPS) and EQ-5D quality of life score
8. Radiologist report of whether RTE had contributed to the radiologist’s decisions, how easy they found using RTE, and whether they found it helpful above using US-alone in predicting malignancy
9. Complication rate from any thyroidectomy at 30-days and 6-months post-surgery – to include haematoma and temporary hypocalcaemia rate at 30 days and vocal cord palsy and permanent hypocalcaemia at 6 months post-operative
10. Resource usage for consultant time and diagnostic testing procedures and subsequent management including consultations and surgical treatments

Original secondary outcome measures:
1. Overall number of FNAC's Required and time to obtain a definitive diagnosis in each arm
2. Non-diagnostic cytology (Thy1) rate for the first FNAC undertaken in each patient
3. Resource use for consultation time and diagnostic testing procedures and quality of life (EQ-5D)
4. Predictive value of a benign (Thy2) cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis for RTE-FNAC and conventional US-FNAC
5. Patients reported anxiety immediately before and after US FNAC, immediately before each consultation for results of US FNA or surgery and at 6 and 12 months from initial US FNAC
6. Radiologist survey-completed by Radiologists at the end of the procedure to identify whether radiologists found US or RTE had contributed to their decision, ease of use, and their prediction of malignancy of the nodule using RTE or US features alone
7. Agreement rates for RTE between local operator and RTE or US features alone
8. Patient reported pain (by Visual analogue score) at procedure
9. Complication rate from any thyroidectomy- haematoma rate, vocal cord palsy at 6 months, permanent hypocalcaemia rate at 6 months
10. Cost-benefit analysis