363 [18F]FDG-PET/CT: cost-utility analysis alongside an RCT 6 Introduction Thyroid malignancy is detected in approximately one in four cytological indeterminate thyroid nodules, including cytology with atypia of undetermined significance or follicular lesions of undetermined significance (Bethesda III, AUS/FLUS) and cytology (suspicious for a) follicular neoplasm (Bethesda IV, FN/SFN) or (suspicious for a) Hürthle cell neoplasm (Bethesda IV, HCN/SHCN) [18]. Current guidelines recommend repeat fine needle aspiration cytology (FNAC) in Bethesda III nodules, and consideration of clinical features, ultrasound characteristics and patient preference in both Bethesda III and IV nodules, before deciding to proceed with either active surveillance or diagnostic surgery [17, 18, 464, 500]. In the Netherlands, from 2017-2019 approximately 1300 Bethesda III and 650 Bethesda IV cytology results were reported per year. Many of these patients underwent diagnostic surgery [525]. Better preoperative differentiation could avoid futile diagnostic surgeries for benign nodules of indeterminate cytology, including the associated costs, risks of surgical complications, lifelong thyroid hormone substitution in patients with subsequent hypothyroidism, and possible negative influence on the patients’ health-related quality of life (HRQoL) [465, 466, 526]. However, none of the plethora of available additional diagnostics are currently part of the standard diagnostic workup following national or international guidelines [17, 25, 467, 490, 491]. Our recent randomised controlled multicentre trial confirmed the results of our previous metaanalysis and demonstrated that implementation of 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography ([18F]FDG-PET/CT) in the preoperative workup accurately ruled out malignancy and prevented 40% of the futile diagnostic surgeries for benign nodules [38]. If the application of [18F]FDG-PET/CT is limited to nodules with non-Hürthle cell cytology (AUS/FLUS and FN/SFN), a 48% reduction can be established, optimizing therapeutic yield and limiting the unbeneficial use of valuable resources [501]. Prior to the implementation of any new test or procedure, it is crucial to evaluate cost-utility. We previously reported a model-based cost-utility analysis of [18F]FDG-PET/CT in a European setting, which demonstrated that [18F]FDG-PET/CT could be cost-effective as compared to management with diagnostic surgery or molecular testing over a five year period [29, 38]. To the best of our knowledge, no cost-utility analysis was performed alongside a clinical trial to date, even though such a design would offer a high level of evidence and a most accurate reflection of real-world clinical practice. Here we present the results of the cost-utility analysis derived from our randomised controlled multicentre trial. In this analysis, we compared the lifelong societal costs and quality adjusted life years (QALYs) of an [18F]FDG-PET/CT-driven workup to the costs and QALYs of diagnostic surgery in patients with indeterminate thyroid nodules. The observed and prospectively collected 1-year trial outcomes were extrapolated using a Markov model.
RkJQdWJsaXNoZXIy MTk4NDMw