308 chapter 4 to the 26 nodules that were presumed benign during active surveillance, in total, 98 of 132 (74.2%) nodules were considered benign: 63 of 91 (69%) in the [18F]FDG-PET/CT-driven group and 35 of 41 (85%) in the diagnostic surgery group. Despite successful stratified randomisation, the rate of malignant/borderline nodules appeared higher in the [18F]FDG-PET/CT-driven group (28/91, 31%) than in the diagnostic surgery group (6/41, 15%). After adjusting for the stratifying variables, the difference was not statistically significant (p=0.08). All patients completed all study-related procedures and one year of follow-up. There were no adverse events. Primary outcomes After one year of follow-up, patient management had been unbeneficial in 38 of 91 (42% [95% CI, 32%-53%]) patients in the [18F]FDG-PET/CT-driven group, compared to 34 of 41 (83% [95% CI, 68%-93%]) patients in the diagnostic surgery group (p<0.001, OR 0.1 [95% CI, 0.1-0.4]). These were all futile diagnostic surgeries for histopathologically benign nodules. There was no unjustified surveillance: no malignancies or borderline tumours were observed in patients under surveillance. [18F]FDG-PET/CT-driven management avoided surgery for 25 of 63 (40% [95% CI, 28%-53%]) benign nodules. In comparison, only one of 35 (3% [95% CI, 0%-15%]) patients in the diagnostic surgery group did not undergo the recommended surgery and was considered benign on ultrasound followup (p=0.002, OR 26.9 [95% CI, 3.3-219.0]) (Table 6). FN/SFN=(suspicious for a) follicular neoplasm. fT4=free thyroxine. HCN/SHCN=(suspicious for a) Hürthle cell neoplasm. IQR=interquartile range. SD=standard deviation. SUVmax=maximum standardised uptake value. SUVmax ratio= ratio between SUVmax of the index nodule and background SUVmax of the surrounding normal thyroid tissue. SUVpeak=peak (ø1-cm sphere) standardised uptake value. SUVpeak ratio=ratio between SUVpeak of the index nodule and background SUVmax of the surrounding normal thyroid tissue. TSH=thyroid stimulating hormone. a: Included as stratifying variable in the stratified randomisation. b: The reference range for TSH is 0.4–4.0 mU/L. c: The reference range for fT4 is approximately 10–25 pmol/L (sex and age dependent). d: Suspicious ultrasound characteristics were defined as presence of at least one of the following characteristics: marked hypoechogenicity (in a solid nodule), irregular shape (i.e., taller-than-wide), irregular margins, and/or presence of microcalcifications.
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