327 [18F]FDG-PET/CT to prevent futile surgery: a blinded, randomised controlled multicentre trial 4 Table 15. Diagnostic accuracy parameters for nodules >10 mm (n=128)a sensitivity specificity NPV PPV benign call rate n TP FP TN FN (95% CI) (95% CI) (95% CI) (95% CI) (95% CI) 128 32 59 35 2 94.1% (80.3%-99.3%) 37.2% (27.5%-47.8%) 94.6% (81.8%–99.3%) 35.2% (25.4%–45.9%) 28.9% (21.2%–37.6%) CI=confidence interval. FN=false-negative. FP=false-positive. PPV=positive predictive value. NPV=negative predictive value. TN=true-negative. TP=true-positive. a: whole-group analysis was performed to estimate diagnostic accuracy parameters. Table 16. Secondary outcomes for nodules >10 mm (n=128) [18F]FDG-PET/CT-driven group diagnostic surgery group (n = 89) (n = 39) p adjusted pc adjusted OR (95% CI)c Surgical complications 13 (15%) 10 (26%)* 0.13a 0.17c 0.5 (0.2-1.3)c in benign nodules (n=94) 9 (15%) 9 (27%) 0.14a 0.24c 0.5 (0.2-1.5)c in malignant/borderline nodules (n=34) 4 (14%) 1 (17%) 1b 0.75c 1.6 (0.1-30.7)c Type of complication following diagnostic surgery Wound infection 1 (1%) 1 (3%) 0.52b 0.59c 0.5 (0.0-8.0)c Hematoma with re-exploration surgery 1 (1%) 1 (3%)* 0.52b 0.55c 0.4 (0.0-8.1)c Seroma 1 (1%) 1 (3%) 0.52b 0.62c 0.5 (0.0-8.7)c Recurrent nerve paralysis 2 (2%) 0 (0%) 1b 1c 2.5E+7 (0-ω)c Hypothyroidism following partial thyroidectomy** 5 (6%)*** 7 (18%)* 0.051b 0.07c 0.3 (0.1-1.1)c Hypoparathyroidism, transient 3 (3%)**** 1 (3%) 1b 0.85c 1.3 (0.1-13.2)c Survival after 1 year 89 (100%) 39 (100%) n.a. n.a. n.a. CI=confidence interval. N.a.=not applicable. N.s.=not specified. OR=odds ratio. *: two complications (hematoma and hypothyroidism) occurred in one patient. **: Hypothyroidism due to partial thyroidectomy included patients who had new levothyroxine-dependent hypothyroidism following a partial thyroidectomy procedure (i.e., hemithyroidectomy and/or isthmus resection). ***: initial total thyroidectomies (n=5) are excluded from the denominator. ****: transient hypoparathyroidism only occurred following initial total thyroidectomy. a: Pearson’s chi-squared test. b: Fisher’s exact test. c: binary logistic regression to adjust for stratifying variables.
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