388 chapter 7 following a benign molecular test result, with HRQoL levels similar to patients with a benign cytology result. Patients with a suspicious as compared to a benign molecular test result initially showed poorer HRQoL, which improved after diagnostic surgery [580, 594]. Our cost-utility study reported that the general one-year and lifelong HRQoL, assessed using the EuroQol 5-dimension 5-level (EQ5D-5L) questionnaire, was similar in patients undergoing [18F]FDG-PET/CT-driven management or diagnostic surgery and that cost-effectiveness was most sensitive to changes in HRQoL following hemithyroidectomy for a histopathologically benign nodule [28]. Therefore, we hypothesized that temporary and/or domain-specific HRQoL differences may exist between patients undergoing active surveillance following a negative [18F]FDG-PET/CT scan and patients undergoing diagnostic surgery, specifically for a benign nodule. In the current study, we performed a comprehensive evaluation of the HRQoL in patients undergoing [18F]FDG-PET/CT for a Bethesda III/IV thyroid nodule. Material and Methods Study population All patients who participated in the previously reported prospective, randomised controlled multicentre trial on the efficacy of [18F]FDG-PET/CT in cytologically indeterminate (Bethesda III/IV) thyroid nodules (EfFECTS trial, registered as NCT02208544) were assessed for eligibility. This trial was performed in eight academic and seven community hospitals in the Netherlands between July 2015 and December 2019, and included adult patients with a Bethesda III or IV thyroid nodule, without increased risk of thyroid malignancy based on their presentation or medical history, who were literate in Dutch or English. Based on cytology, clinical characteristics, and ultrasound features, diagnostic thyroid surgery was scheduled in all patients, in accordance with current international guidelines [17]. Patients who could not be randomised due to a strong preference for either surgery (e.g., for goitre symptoms or cosmetic complaints) or active surveillance were not included in the trial. The current study comprised secondary analyses of HRQoL data acquired during this trial. Trial participants were only eligible for inclusion in the current study if they had completed all trial procedures per protocol; patients with nonadherence to the trial protocol were excluded. The EfFECTS trial, including the current study, was approved by the Medical Research Ethics Committee on Research Involving Human Subjects region Arnhem-Nijmegen, Nijmegen, the Netherlands. Written informed consent was obtained from each of the participants prior to any study activity.
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