404 chapter 7 ThyPRO Multivariate within-group analysis showed that hyperthyroid symptoms (B=1.6, p=0.01), cognitive impairment (B=2.1, p=0.01), and cosmetic complaints (B=1.9, p=0.02) significantly worsened over time for surgical patients with benign histopathology (Table 8). Goitre symptoms (B=-2.7, p<0.001) and anxiety (B=-1.8, p=0.04) improved between baseline and 12 months. Patients with malignancy reported a statistically significant improvement in anxiety (B=-2.5, p=0.05). There were no significant longitudinal changes in patients undergoing active surveillance. Lastly, on multivariate analysis no statistically significant differences were observed in the HRQoL patterns over time between the three groups. Discussion To the best of our knowledge, our randomised controlled multicentre study is the first to assess HRQoL in patients undergoing an [18F]FDG-PET/CT-driven diagnostic workup and subsequent surgical management or active surveillance for a Bethesda III/IV thyroid nodule. These HRQoL evaluations are essential to improve the understanding of the impact that diagnostics and successive management consequences have on patients, and to include HRQoL considerations in shared-decision making processes. We observed sustained HRQoL during the first year of active surveillance in patients with a cytological indeterminate thyroid nodule and negative [18F]FDG-PET/CT scan. These results suggest that the negative [18F]FDG-PET/CT reassured the patients of the low malignancy risk and that no meaningful concerns arose during active surveillance. Patients undergoing diagnostic surgery, however, experienced worsened HRQoL on various physical and psychosocial domains throughout the one-year follow-up, especially during the first 3-6 months. This was primarily observed in patients with benign histopathology, even though visual assessment of Figure 2 suggested quite similar patterns for patients with malignancy without reaching statistical significance, possibly as this group was smaller (n=29 versus n=74). As hypothesized, the decrease in HRQoL in patients with benign histopathology appeared temporary on most scales, gradually recovering over time and no longer showing a statistically significant difference at 12 months relative to baseline. On some scales, however, HRQoL was still worse than baseline after one year, including cognitive impairment For the RAND-36, scores range from 0 (worst score) to 100 (best score). *: p value indicates whether the between-group difference at baseline is statistically significant. †: p value indicates whether the within-group change over time is statistically significant. §: p value indicates whether the differences in de change over time between the groups is statistically significant.
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