Integrating Artificial Intelligence in Thyroid Nodule Management: Clinical Outcomes and Cost-Effectiveness Analysis.
Authors
Affiliations (14)
Affiliations (14)
- Rovira i Virigili University. Faculty of Medicine. PhD School of Biomedical Sciences. Catalunya Avenue, 35, 43002, Tarragona, Catalonia, Spain.
- Endocrinology and Nutrition Department. Verge de la Cinta Hospital, Carrer de les Esplanetes, 44-58, 43500 Tortosa, Catalonia, Spain.
- Research Support Unit-Terres de l'Ebre, Institut Català de la Salut, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, (IDIAPJGol), Colon Avenue, 16-20, 43500, Tortosa, Spain.
- Nursery School-Terres de l´Ebre Campus, Rovira i Virgili Universtiy, Remolins Avenue, 13-15, 43500, Tortosa, Catalonia, Spain.
- Department of Medicine. University of Valencia, Av. de Blasco Ibáñez, 15, El Pla del Real, 46010 Valencia, Valencian Community Spain.
- Department of Endocrinology and Nutrition. Hospital Clínico Universitario of Valencia. INCLIVA Av. de Blasco Ibáñez, 17, El Pla del Real, 46010 Valencia, Valencian Community Spain.
- CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM). Monforte de Lemos Avenue, 3-5, 28029, Madrid, Madrid Community, Spain.
- Department of Economics. Rovira i Virgili University. Campus Bellissens, Universitat Avenue, 1, 43204 Reus, Catalonia, Spain.
- Research Group ECO-NEXT (Economic Challenges for the Next Generation - SGR2021-00729). Campus Bellissens, Universitat Avenue, 1, 43204 Reus, Catalonia, Spain.
- Research Centre on Economics and Sustainability (ECO-SOS). Universitat Rovira I Virgili. Universitat Avenue, 1, 43204 Reus, Catalonia, Spain.
- Endocrinology and Nutrition Department. University General Hospital of Castellón, Avinguda de Benicàssim, 128, 12004 Castellón de la Plana, Castellón, Valencian Community, Spain.
- Endocrinology and Nutrition Department. Hospital de la Santa Creu i Sant Pau, Sant Quintí Street, 89, 08025, Barcelona, Catalonia, Spain.
- Endocrinology and Nutrition Department. Son Espases University Hospital, Carretera de Valldemossa, 79, Nord, 07120 Palma, Balearic Islands, Spain.
- Faculty of Medicine. Balearic Islands University. Carretera de Valldemossa, 79, Nord, 07120 Palma, Balearic Islands, Spain.
Abstract
The increasing incidence of thyroid nodules (TN) raises concerns about overdiagnosis and overtreatment. This study evaluates the clinical and economic impact of KOIOS, an FDA-approved artificial intelligence (AI) tool for the management of TN. A retrospective analysis was conducted on 176 patients who underwent thyroid surgery between May 2022 and November 2024. Ultrasound images were evaluated independently by an expert and novice operators using the American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS), while KOIOS provided AI-adapted risk stratification. Sensitivity, specificity, and Receiver-Operating Curve (ROC) analysis were performed. The incremental cost-effectiveness ratio (ICER) was defined based on the number of optimal care interventions (FNAB and thyroid surgery). Both deterministic and probabilistic sensitivity analyses were conducted to evaluate model robustness. KOIOS AI demonstrated similar diagnostic performance to the expert operator (AUC: 0.794, 95% CI: 0.718-0.871 vs. 0.784, 95% CI: 0.706-0.861; p = 0.754) and significantly outperformed the novice operator (AUC: 0.619, 95% CI: 0.526-0.711; p < 0.001). ICER analysis estimated the cost per additional optimal care decision at -€8,085.56, indicating KOIOS as a dominant and cost-saving strategy when considering a third-party payer perspective over a one-year horizon. Deterministic sensitivity analysis identified surgical costs as the main drivers of variability, while probabilistic analysis consistently favored KOIOS as the optimal strategy. KOIOS AI is a cost-effective alternative, particularly in reducing overdiagnosis and overtreatment for benign TNs. Prospective, real-life studies are needed to validate these findings and explore long-term implications.