399 Health-related quality of life following [18F]FDG-PET/CT 7 ThyPRO Longitudinal, within-group comparison (Figure 4, Table 4) indicated that patients in all three groups experienced an improvement of the negative influence of their thyroid disorder on their QoL over time. Besides that, patients who underwent active surveillance for an [18F]FDG-negative nodule generally reported stable HRQoL scores throughout the year; no statistically significant or clinically relevant longitudinal changes were observed in this group. In all patients undergoing diagnostic surgery, goitre symptoms improved from 3 to 12 months. In patients with benign histopathology, goitre symptoms deteriorated between baseline and 3 months but had improved at 12 months as compared to baseline. Furthermore, patients with benign histopathology reported more tiredness, social impairment, daily life impairment and sex life impairment at 3 and/or 6 months as compared to baseline. At 12 months, these differences were not statistically significant relative to baseline. Daily life impairment significantly improved from 3 to 12 months. In contrast, more cognitive impairment and cosmetic complaints were observed at 3, 6 and 12 months relative to baseline. The ThyPRO composite QoL score showed worse HRQoL at 3 months as compared to baseline. Finally, an unexpected increase in hyperthyroid symptoms was observed at 12 months as compared to baseline in patients with benign histopathology. Subgroup analysis showed that this difference could not be explained by the ten of 74 (14%) patients who developed hypothyroidism and started levothyroxine substitution following their diagnostic surgery: these patients reported a similar increase in hyperthyroid symptoms as compared to the 64 (86%) patients without postoperative hypothyroidism (mean difference between baseline and 12 months +3.9 and +4.7, respectively, p=0.86). Patients with malignant histopathology experienced more cognitive, social, and daily life impairment at 6 months as compared to baseline. They reported less anxiety at 12 months as compared to baseline. Univariate between-group comparison (Table 5) suggested better HRQoL in patients under active surveillance than patients with benign histopathology, with statistically significant and/or clinically important differences on multiple domains and measurement points. Patients under active surveillance reported less goitre symptoms, tiredness, anxiety, emotional susceptibility, social impairment, cosmetic complaints, and negative influence on QoL at 3 and/or 6 months. At 3, 6 and 12 months, less cognitive impairment, depressivity, and daily life impairment were reported. The ThyPRO composite QoL score also showed statistically significant and/or clinically important differences at 3, 6 and 12 months between these groups. Between histopathologically benign and malignant groups, only a difference in anxiety at 12 months was observed. No other statistically significant and/or clinically relevant differences were observed between these two groups. Figure 3. Changes in mean RAND-36 scores over time. For the RAND-36, scores range from 0 (worst score) to 100 (best score). The p value indicates the statistically significant within-group differences between two assessments over time, using a paired samples t-test. Full data, including mean differences and other p values, are presented in Table 3.
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