367 [18F]FDG-PET/CT: cost-utility analysis alongside an RCT 6 First year costs and utilities Real-world volumes of thyroid nodule-related health care consumption during one year, counted from the date of the [18F]FDG-PET/CT scan (defined as baseline), were extracted from individual medical records for each patient. The extracted data included all thyroid surgery and associated days of hospitalization, additional procedures and days of hospitalization following surgical complications, outpatient clinic visits and diagnostics that were related to the diagnosis and treatment of the indeterminate thyroid nodule, additional diagnostic procedures and consultations with other physicians related to [18F]FDGPET/CT incidental findings, and use of thyroid-related medication. Volumes concerning non-thyroidrelated health care consumption, productivity losses and HRQoL during the first year were patientreported at baseline, 3, 6 and 12 months, using the iMTA Medical Consumption Questionnaire (iMCQ), the iMTA Productivity Costs Questionnaire (iPCQ) and the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire, respectively (Figure 1) [471-473]. Questions on health care and productivity covered a fixed recall period by design of each questionnaire, varying from one to three months; intermediate periods were individually interpolated from the closest available questionnaire. Utilities were calculated from the EQ-5D-5L domain scores using the Dutch tariff [474]. These utilities represent the valuation of quality of life on a scale from zero (worst possible health, similar to death) to one (perfect health). Quality adjusted life years (QALYs) for the first year were estimated as the area under the utility curve [470, 474]. The estimated cost of one partial-body [18F]FDG-PET/CT scan was €754 [476, 477]. Other health care costs were valued using reference prices or the 2019 reimbursement rates of the Dutch System of DiagnosisTreatment Combinations, where appropriate and available [477]. Costs for complications of thyroid surgery (i.e., prolonged hospitalization, re-admission, and/or additional surgical procedures) were estimated using complication rates reported in literature and procedural Dutch reimbursement rates [476]. Costs of productivity losses were valued using the friction cost method and reference prices for productivity [477]. Travel expenses were included at €0.19 per kilometre [477]. We estimated all costs from a Dutch societal perspective in Euro. All prices were indexed to 1 December 2019 using the Dutch consumer price index [478]. The total societal costs per patient were estimated as the sum of medical costs for all thyroid nodule-related and other health care consumption, patient costs (i.e., travel expenses and informal care), and costs from productivity losses. All costs related to the [18F]FDG-PET/CT, including procedure costs, costs for additional healthcare consumption for incidental [18F]FDG-PET/CT findings, pertinent travel expenses, and other reported patient costs were only taken into account for the patients in the [18F]FDG-PET/CT-driven group. Multiple imputation was applied to account for possibly selectively missing questionnaire data, using age, sex, allocation, EQ-5D-5L utility scores and time-dependent variables for thyroid surgery and benign or malignant histopathological diagnosis as predictor variables. One hundred imputed datasets were created for the 1-year data.
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