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Diagnostic Performance of Ultrasound vs Ultrasound-Guided FNAC in Thyroid Nodules: Data From the ElaTION Trial.

Clinical visual abstract: Diagnostic Performance of Ultrasound vs Ultrasound-Guided FNAC in Thyroid Nodules: Data From the ElaTION Trial.

Clinical Bottom Line

In a J Clin Endocrinol Metab randomized trial, Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the British Thyroid Association classification. Key reported results included Of the 982 participants, a final...

Summary: In a J Clin Endocrinol Metab randomized trial, Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the British Thyroid Association classification. Key reported results included Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses.

PICO Summary

ElementDetail
PopulationAdults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) vs US-FNAC.
InterventionAdults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) vs US-FNAC.
ComparisonComparator details are reported in the abstract methods.
OutcomeOf the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US alone was the same as US-FNAC (0.91 [95% CI, 0.85-0.97] vs 0.87 [95% CI, 0.80-0.95] P = .37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, P < .0001). The malignancy rate on histology in a nodule classified as benign on ultrasound (U2) was 9/263 (3.42%) and on cytology (Thy2) was 15/353 (4.25%), whereas the malignancy…
RCT J Clin Endocrinol Metab · 2025

Diagnostic Performance of Ultrasound vs...

Primary RCT · General endocrinology

Trial design
General endocrinology Enrolled & assessed RANDOMISED RCT Intervention Active arm n = NR Comparator Comparator n = NR Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final...
Proportion reaching endpoint
NR Reported percentage 95% Intervention 95% Comparator ARRSee PICO outcome
Reported result
95%
Primary abstract result
Results
982
Abstract-reported estimate
Interpretation
Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the...
Source conclusion
Limitations
95% CI not stated
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⬡ Bottom Line

Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the British Thyroid Association classification. However, findings also suggest caution regarding existing recommendations for conservative...

Expert Commentary

This J Clin Endocrinol Metab randomized trial evaluated Diagnostic Performance of Ultrasound vs Ultrasound-Guided FNAC in Thyroid Nodules: Data From the ElaTION Trial. The abstract describes the study as follows: Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) vs US-FNAC. The main reported results were: Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US alone was the same as US-FNAC (0.91 [95% CI, 0.85-0.97] vs 0.87 [95% CI, 0.80-0.95] P = .37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, P < .0001). The malignancy rate on histology in a nodule classified as… The authors conclude: Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the British Thyroid Association classification. However, findings also suggest caution regarding existing… The clinical value of the result depends on whether the trial population, comparator, follow-up and outcome match the decision in front of the clinician. Can I use this with my patients? The findings can..

References

Mehanna H, Nankivell P, Boelaert K, et al.. Diagnostic Performance of Ultrasound vs Ultrasound-Guided FNAC in Thyroid Nodules: Data From the ElaTION Trial.. J Clin Endocrinol Metab. 2025-Jun-17. doi:10.1210/clinem/dgae682. PMID: 39359050.

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