389 Health-related quality of life following [18F]FDG-PET/CT 7 Study design and procedures The full methodology of the EfFECTS trial was reported prior, including comprehensive descriptions regarding patient eligibility, selection, randomisation, blinding, [18F]FDG-PET/CT procedures, and sample size calculation [501]. In summary, all patients underwent [18F]FDG-PET/CT and were randomly allocated to an [18F]FDG-PET/CT-driven group or diagnostic surgery group. Dependent on their allocation and the [18F]FDG-PET/CT result, patients were advised to proceed with the scheduled diagnostic thyroid surgery (i.e., patients with an [18F]FDG-positive nodule in the [18F]FDG-PET/CTdriven group and all patients allocated to the diagnostic surgery group) or were advised to refrain from surgery and undergo active surveillance (i.e., patients allocated to the [18F]FDG-PET/CT-driven group with an [18F]FDG-negative nodule). Treatment allocation and the result of the [18F]FDG-PET/ CT were undisclosed in case diagnostic thyroid surgery was advised. Patients who were advised active surveillance were counselled that their negative [18F]FDG-PET/CT result had a remaining risk of malignancy of less than 5%, based on performance characteristics of [18F]FDG-PET/CT that were established in literature [38] and confirmed by the trial [501]. Active surveillance consisted of at least one ultrasound procedure and a follow-up visit with the patient’s local endocrinologist one year after the [18F]FDG-PET/CT; additional intermediate follow-up visits were allowed at the discretion of the local physicians. In both study groups, the patient and his/her local physician were free to deviate from the study treatment advice at any time. Postoperative management adhered to the Dutch national guidelines [467]. The current study adhered to the local histopathological diagnosis as a reference standard, as this diagnosis determined the individual patients’ postoperative course of treatment and likely best reflects the patient’s illness perception and perceived HRQoL. For the primary trial endpoints, central histopathology review was performed, causing minor discrepancies between the current and previous papers [501]. Patients with a non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) or follicular tumour of uncertain malignant potential (FT-UMP), were categorised as benign, as patients were counselled and postoperatively treated as such. For the current study, patients were categorised into three groups: patients who underwent diagnostic surgery and had i) benign or ii) malignant histopathology, and iii) patients who had an [18F]FDG-negative nodule and underwent active surveillance. HRQoL assessment HRQoL was assessed through self-administered questionnaires at baseline and 3, 6 and 12 months, counted from the date of the [18F]FDG-PET/CT scan. Upon study inclusion, patients indicated whether they preferred to receive electronic questionnaires with email invitations or printed questionnaires that were sent to their home address with a stamped return envelope included. At each time point,
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