301 [18F]FDG-PET/CT to prevent futile surgery: a blinded, randomised controlled multicentre trial 4 nodule, irregular shape (i.e., taller-than-wide), irregular margins (i.e., lobulated, infiltrative), and/ or presence of microcalcifications. In the diagnostic surgery group, the treatment advice for all patients was to proceed to the scheduled diagnostic surgery, in accordance with the current international guidelines [17, 467]. In both study groups, the patient and his/her physician were free to deviate from the study treatment advice at any time. All postoperative patient management was based on the local histopathological diagnosis and current international guidelines [17]. After completion of all study procedures and data collection, all histopathology was centrally reviewed by a dedicated thyroid pathologist (AE). In case of a discordant review, a second central pathologist was consulted for a consensus meeting. Incidentally detected (micro)carcinomas located outside the index nodule were not considered for the main outcome measures. HRQoL and societal costs were assessed during one year, calculated from the date of the [18F] FDG-PET/CT scan. Patients were asked to complete the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), the iMTA Medical Consumption Questionnaire (iMCQ), and the iMTA Productivity Costs Questionnaire (iPCQ) at 0 (baseline), 3, 6, and 12 months [470-473]. Health-related quality of life (HRQoL) was assessed during one year, counted from the date of the [18F]FDG-PET/CT scan. To estimate the HRQoL, patients were asked to complete the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) at 0 (baseline), 3, 6, and 12 months, counted from the date of the [18F]FDG-PET/CT scan [471]. Patients were given the option to complete either webbased questionnaires with email invitations, or paper questionnaires sent to their home address with stamped return envelopes included. From filled questionnaires, we calculated utility scores using the EQ-5D-5L domain scores and the appropriate Dutch tariff [474]. Visual analogues scale (VAS) scores were transformed to utilities using the formula Utility = 1 – (1 – (VAS/100))1.61 [475]. We used multiple imputation to account for possible selectively missing values, using age (calculated as age at baseline), sex, allocation, EQ-5D-5L utility scores and time-dependent variables for thyroid surgery and benign or malignant local histopathological diagnosis as predictor variables. Quality adjusted life years (QALYs) for the first year were estimated as the area under the utility curves [470]. Differences between randomisation groups were statistically analysed using independent samples t-tests with unequal variances. A generalized linear model (GLM) was used to adjust for the stratifying factors and malignancy rate; the adjusted p-value, corrected mean difference and 95% confidence interval are presented. As the postoperative treatment of the individual patients was based on the local histopathological diagnosis and potentially influences the perceived HRQoL, this diagnosis was included in the GLM.
RkJQdWJsaXNoZXIy MTk4NDMw