324 chapter 4 study groups (p=1), and included one patient in each group who declined the advised surgery (Table 12). [18F]FDG-PET/CT-driven management avoided significantly more futile surgeries in nonHürthle cell nodules (48% [95% CI, 33%-63%]) than in Hürthle cell nodules (13% [95% CI, 2%-40%]) (p=0.02). Subgroup analysis of nodules >10 mm (128/132 patients, excluding two 10 mm nodules from each group) and subgroup analysis for the primary outcome for a strictly benign-malignant differentiation demonstrated similar therapeutic yield and diagnostic accuracy as compared to the main results (Tables 13-18 and Tables 19-21, respectively). Discussion The EfFECTS trial demonstrated that [18F]FDG-PET/CT-driven management resulted in 40% avoided futile surgeries for benign nodules after one year. The high 94.1% sensitivity of [18F]FDG-PET/CT ensures that omitting diagnostic surgery does not compromise oncological safety. Despite patient cross-over between surgical and non-surgical management strategies, these results are in line with our previous meta-analysis, in which we estimated that [18F]FDG-PET/CT-driven management could accomplish a reliable maximum 47% reduction in diagnostic surgeries for benign nodules [29, 38]. The secondary outcomes of the trial showed significantly lower one-year societal costs of [18F] FDG-PET/CT-driven management, amply compensating the additional costs of the [18F]FDG-PET/CT (€754) by other cost-savings. Combined with similar HRQoL in both groups, a high likelihood of costeffectiveness of an [18F]FDG-PET/CT-driven diagnostic workup is suggested. Finally, a trend towards fewer cases of postoperative medication-dependent hypothyroidism after hemithyroidectomy was demonstrated. The Hürthle cell nodules in our population were nearly all [18F]FDG-positive, irrespective of malignant or benign histopathology. Visual assessment of [18F]FDG-PET/CT did not contribute to any reduction of futile surgeries in this subgroup. To prevent the unbeneficial application of [18F]FDG-PET/CT and optimise its therapeutic yield, it should only be offered to patients with non-Hürthle cell AUS/FLUS or FN/SFN cytology. Nodules with Hürthle cell cytology should be excluded from visual analysis with [18F]FDG-PET/CT. Any benefits of quantitative [18F]FDG-PET/CT assessment methods, such as SUVderived analysis, texture analysis, and radiomics, have shown potential in indeterminate thyroid nodules and [18F]FDG-positive thyroid incidentaloma, although current evidence is limited and further studies are required [480-482]. Other diagnostics, such as molecular analysis for specific driver mutations, mitochondrial DNA mutations and copy number variations, should be considered for Hürthle cell nodules [25, 483, 484].
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