176 chapter 2 GEC in Bethesda III nodules Nine of the included studies reported GEC performance for Bethesda III and IV nodules separately [50, 164, 167-171, 180, 182]. Subgroup analysis shows a GEC test performance similar to the entire indeterminate population in both groups. In the 276 Bethesda III nodules reported in nine studies, malignancy rate was 34% (95/276), including 30 PTC (32%), 28 FVPTC (29%), one FTC (1.1%), one FTC-OV (1.1%), one mPTC (1.1%) and 34 malignancies of unspecified subtype (36%). Estimated pooled sensitivity, specificity, positive and negative LR are 98.9% (95% CI: 82.1%-99.9%), 10.9% (95% CI: 3.4%-30.1%), 1.11 (95% CI: 0.97-1.27) and 0.10 (95% CI: 0.01-1.68), respectively. The AUC is 0.82 (95% CI: 0.78-0.85) (Table 36, Figure 41 and 42). Table 36. Estimated pooled test performance of Afirma® GEC in Bethesda III thyroid nodules nH BIII TP FP FN TN malignant (TP+FN/ni) sensitivity (95% CI), % specificity (95% CI), % LR+ (95% CI) LR- (95% CI) Alexander 2012 129 28 46 3 52 24% 90 (74-98) 53 (43-63) 1.92 (1.51-2.45) 0.18 (0.06-0.54) Harrell 2014 26 14 8 1 3 58% 93 (68-100) 27 (6-61) 1.28 (0.87-1.89) 0.24 (0.03-2.05) Lastra 2014 18 11 7 0 0 61% 100 (72-100) 0 (0-41) 1.02 (0.83-1.27) 0.67 (0.01-30.30) McIver 2014 5 1 4 0 0 20% 100 (3-100) 0 (0-60) 0.83 (0.36-1.95) 2.50 (0.07-87.95) Sullivan 2014 7 2 4 0 1 29% 100 (16-100) 20 (1-72) 1.11 (0.56-2.20) 0.67 (0.04-11.94) Brauner 2015 20 2 16 0 2 10% 100 (16-100) 11 (1-35) 0.96 (0.56-1.64) 1.27 (0.08-20.45) Celik 2015 6 4 2 0 0 67% 100 (40-100) 0 (0-84) 1.08 (0.60-1.94) 0.60 (0.02-23.07) Witt 2016 10 3 7 0 0 30% 100 (29-100) 0 (0-41) 0.93 (0.62-1.41) 2.00 (0.05-83.50) Yang 2016 55 26 27 0 2 47% 100 (87-100) 7 (1-23) 1.07 (0.95-1.21) 0.22 (0.01-4.43) POOLED RESULTS 276 91 121 4 60 34.4% 98.9 (82.1-99.9) 10.9 (3.4-30.1) 1.11 (0.97-1.27) 0.10 (0.01-1.68) FN: false negative. FP: false positive. LR+: positive likelihood ratio. LR-: negative likelihood ratio. nH: number of indeterminate thyroid nodules with conclusive index test and histopathological follow-up. TN: true negative. TP: true positive.
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