375 [18F]FDG-PET/CT: cost-utility analysis alongside an RCT 6 First year utilities and costs EQ-5D-5L, iMCQ and iPCQ questionnaires were fully completed at baseline, 3, 6, and 12 months by 121 (91.7%), 114 (86.4%), 107 (81.1%) and 106 (80.3%) of 132 patients, respectively, which were equally distributed across both randomisation groups. According to the EQ-5D-5L, the valuation of quality of life was similar in the [18F]FDG-PET/CT-driven and diagnostic surgery groups at all four measurements (Table 5). QALYs estimated from the EQ-5D-5L for the first year were similar in both groups (p=0.57). The medical costs related to the index thyroid nodule were primarily determined by all regular healthcare consumption: a diagnostic workup, outpatient clinic visits, surgeries, medication, and RAI in case of malignancy (Table 6, Supplementary Table 4). In the [18F]FDG-PET/CT-driven group, additional costs were made for the [18F]FDG-PET/CT procedure (€754 per patient), but fewer diagnostic surgeries were performed, resulting in lower surgical costs per patient. Based on observed healthcare consumption, the mean costs for regular thyroid nodule-related healthcare were €6,100 in the [18F]FDG-PET/CT-driven group as compared to €7,400 in the diagnostic surgery group, with a mean difference of -€1,300 (p=0.01). Additional healthcare consumption due to incidental findings on the [18F]FDG-PET/CT (e.g., costs for additional ultrasound and/or FNAC procedures for an [18F]FDGpositive thyroid incidentaloma) increased the medical costs in the [18F]FDG-PET/CT-driven group. Table 4. Probabilities, costs, and utilities for univariate sensitivity analyses Range References Probabilities Yearly probability that active surveillance of [18F]FDG-negative nodule ends 0.05 - 1.00 [528-531], expert opinion Yearly probability of surgery for benign nodule after continued surveillance for [18F]FDG-negative nodule 0.001 - 0.10 [29, 178, 530-532], EfFECTS Yearly probability of (surgery for) a missed malignancy after initial surveillance for [18F]FDG-negative nodule 0.00 - 0.25 [38, 486, 495, 496], EfFECTS Any surgical complication (transient, permanent, and hypothyroidism) -100% to +100% [29, 558] Costs Price of [18F]FDG-PET/CT €400 - €5,000 [29, 178, 300, 495, 558] Price of HT €2,500 - €20,000 [29, 178, 300, 495, 558] Annual costs of observation after negative [18F]FDG-PET/CT €0 - €1,000 [495, 558] Costs of [18F]FDG-PET/CT incidental findings €0 - €1,000 Disutility Observation after negative [18F]FDG-PET/CT 0.00 - 0.10 [29, 495] Observation after HT for benign nodule 0.00 - 0.10 [29, 495] EfFECTS, observed data from the first year of the EfFECTS trial were included as a source. HT, hemithyroidectomy.
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