Background
Methods
Study population
Ultrasound and pathological report analysis
Data collection
Evaluation of the laboratory data
Definitions of ultrasound characteristics
Composition
Echogenicity
Margin
Calcification
Kwak-TIRADS
ACR TI-RADS
Statistical analysis
Results
The baseline characteristics of all the participants
Variables | Total (n = 509) |
---|---|
Age, Mean ± SD | 48.22 ± 12.31 |
Gender, n (%) | |
Male | 154 (30.26) |
Female | 355 (69.74) |
Groups, n (%) | |
Benign nodules | 264 (51.87) |
Malignant nodules | 245 (48.13) |
PTC | 189 (77.14) |
MTC | 56 (22.86) |
ACR TI-RADS score, M(Q1,Q3) | 6 (3,9) |
ACR TI-RADS,n(%) | |
TR1 | 54 (10.61) |
TR2 | 30 (5.89) |
TR3 | 66 (12.97) |
TR4 | 116 (22.79) |
TR5 | 243 (47.74) |
Kwak TI-RADS,n(%) | |
TIRADS 2 | 54 (10.61) |
TIRADS 3 | 26 (5.11) |
TIRADS 4 | 405 (79.57) |
4a | 85 (20.99) |
4b | 80 (19.75) |
4c | 240 (59.26) |
TIRADS 5 | 24 (4.72) |
Comparisons of baseline data, laboratory inspection data and sonographic features in patients between benign and malignant nodules groups
Variable | Total (n = 509) | Groups | Statistical magnitude | P | |
---|---|---|---|---|---|
Benign nodule (n = 264) | Malignant nodule (n = 245) | ||||
Age, Mean ± SD | 48.22 ± 12.31 | 50.08 ± 12.32 | 46.22 ± 12.00 | t = 3.580 | < 0.001 |
Gender, n (%) | χ2 = 2.312 | 0.128 | |||
Male | 154 (30.26) | 72 (27.27) | 82 (33.47) | ||
Female | 355 (69.74) | 192 (72.73) | 163 (66.53) | ||
Tumor biomarkers | |||||
CEA, n (%) | χ2 = 35.577 | < .001 | |||
Negative | 385 (75.64) | 194 (73.48) | 191 (77.96) | ||
Positive | 37 (7.27) | 6 (2.27) | 31 (12.65) | ||
Unknown | 87 (17.09) | 64 (24.24) | 23 (9.39) | ||
CT, n (%) | χ2 = 46.369 | < .001 | |||
Negative | 383 (75.25) | 192 (72.73) | 191 (77.96) | ||
Positive | 32 (6.29) | 2 (0.76) | 30 (12.24) | ||
Unknown | 94 (18.47) | 70 (26.52) | 24 (9.80) | ||
Thyroid function | |||||
TSH, n(%) | χ2 = 1.979 | 0.372 | |||
Negative | 468 (91.94) | 247 (93.56) | 221 (90.20) | ||
Positive | 32 (6.29) | 13 (4.92) | 19 (7.76) | ||
Unknown | 9 (1.77) | 4 (1.52) | 5 (2.04) | ||
TPOAb, n(%) | χ2 = 16.880 | < .001 | |||
Negative | 443 (87.03) | 242 (91.67) | 201 (82.04) | ||
Positive | 47 (9.23) | 11 (4.17) | 36 (14.69) | ||
Unknown | 19 (3.73) | 11 (4.17) | 8 (3.27) | ||
TGAb, n(%) | χ2 = 9.051 | 0.011 | |||
Negative | 453 (89.00) | 242 (91.67) | 211 (86.12) | ||
Positive | 38 (7.47) | 11 (4.17) | 27 (11.02) | ||
Unknown | 18 (3.54) | 11 (4.17) | 7 (2.86) | ||
TRAb, n(%) | χ2 = 7.287 | 0.026 | |||
Negative | 3 (0.59) | 2 (0.76) | 1 (0.41) | ||
Positive | 407 (79.96) | 199 (75.38) | 208 (84.90) | ||
Unknown | 99 (19.45) | 63 (23.86) | 36 (14.69) | ||
Thyroid nodule | |||||
Maximum diameter of nodule, M (Q1, Q3) | 1.80 (0.80, 3.40) | 3.00 (1.70, 4.00) | 0.90 (0.60, 1.70) | Z = -11.205 | < 0.001 |
Composition, n (%) | - | < 0.001 | |||
Cystic | 54 (10.61) | 54 (20.45) | 0 (0.00) | ||
Spongy | 4 (0.79) | 4 (1.52) | 0 (0.00) | ||
Solid Cystic | 72 (14.15) | 60 (22.73) | 12 (4.90) | ||
Solid | 379 (74.46) | 146 (55.30) | 233 (95.10) | ||
Echogenicity, n (%) | χ2 = 155.837 | < 0.001 | |||
Anechoic | 55 (10.81) | 55 (20.83) | 0 (0.00) | ||
Hyperechoic | 86 (16.90) | 80 (30.30) | 6 (2.45) | ||
Hypoechoic | 341 (66.99) | 125 (47.35) | 216 (88.16) | ||
Markedly Hypoechoic | 27 (5.30) | 4 (1.52) | 23 (9.39) | ||
Shape, n (%) | χ2 = 75.780 | < 0.001 | |||
A/T < 1 | 383 (75.25) | 241 (91.29) | 142 (57.96) | ||
A/T ≥ 1 | 126 (24.75) | 23 (8.71) | 103 (42.04) | ||
Margin, n(%) | χ2 = 128.221 | < 0.001 | |||
Smooth or unclear | 367 (72.10) | 247 (93.56) | 120 (48.98) | ||
Irregular or lobulated | 107 (21.02) | 17 (6.44) | 90 (36.73) | ||
Extrathyroid extension | 35 (6.88) | 0 (0.00) | 35 (14.29) | ||
Calcification, n (%) | χ2 = 132.228 | < 0.001 | |||
None | 270 (53.05) | 193 (73.11) | 77 (31.43) | ||
Coarse calcifications | 47 (9.23) | 34 (12.88) | 13 (5.31) | ||
Rim calcifications | 12 (2.36) | 4 (1.52) | 8 (3.27) | ||
Micro calcifications | 180 (35.36) | 33 (12.50) | 147 (60.00) | ||
Metastatic lymph nodes, n (%) | χ2 = 70.535 | < 0.001 | |||
No | 451 (88.61) | 264 (100.00) | 187 (76.33) | ||
Yes | 58 (11.39) | 0 (0.00) | 58 (23.67) |
Comparisons of baseline data, laboratory inspection data and sonographic features among MTC, PTC and benign nodules groups
Variable | Total (n = 509) | Benign nodule (n = 264) | PTC (n = 189) | MTC (n = 56) | Statistical magnitude | P |
---|---|---|---|---|---|---|
Age, Mean ± SD | 48.22 ± 12.31 | 50.08 ± 12.32 | 45.62 ± 11.94 | 48.21 ± 12.09 | F = 7.388 | < .001 |
Gender, n (%) | χ2 = 4.300 | 0.116 | ||||
Male | 154 (30.26) | 72 (27.27) | 59 (31.22) | 23 (41.07) | ||
Female | 355 (69.74) | 192 (72.73) | 130 (68.78) | 33 (58.93) | ||
Tumor biomarkers | ||||||
CEA, n (%) | χ2 = 122.238 | < .001 | ||||
Negative | 385 (75.64) | 194 (73.48) | 172 (91.01) | 19 (33.93) | ||
Positive | 37 (7.27) | 6 (2.27) | 4 (2.12) | 27 (48.21) | ||
Unknown | 87 (17.09) | 64 (24.24) | 13 (6.88) | 10 (17.86) | ||
CT, n (%) | χ2 = 152.534 | < .001 | ||||
Negative | 383 (75.25) | 192 (72.73) | 172 (91.01) | 19 (33.93) | ||
Positive | 32 (6.29) | 2 (0.76) | 1 (0.53) | 29 (51.79) | ||
Unknown | 94 (18.47) | 70 (26.52) | 16 (8.47) | 8 (14.29) | ||
Thyroid function | ||||||
TSH, n (%) | Fisher | 0.151 | ||||
Negative | 468 (91.94) | 247 (93.56) | 171 (90.48) | 50 (89.29) | ||
Positive | 32 (6.29) | 13 (4.92) | 16 (8.47) | 3 (5.36) | ||
Unknown | 9 (1.77) | 4 (1.52) | 2 (1.06) | 3 (5.36) | ||
TPOAb, n (%) | χ2 = 27.822 | < .001 | ||||
Negative | 443 (87.03) | 242 (91.67) | 158 (83.60) | 43 (76.79) | ||
Positive | 47 (9.23) | 11 (4.17) | 29 (15.34) | 7 (12.50) | ||
Unknown | 19 (3.73) | 11 (4.17) | 2 (1.06) | 6 (10.71) | ||
TGAb, n (%) | χ2 = 22.977 | < .001 | ||||
Negative | 453 (89.00) | 242 (91.67) | 165 (87.30) | 46 (82.14) | ||
Positive | 38 (7.47) | 11 (4.17) | 23 (12.17) | 4 (7.14) | ||
Unknown | 18 (3.54) | 11 (4.17) | 1 (0.53) | 6 (10.71) | ||
TRAb, n (%) | χ2 = 74.632 | < .001 | ||||
Negative | 3 (0.59) | 2 (0.76) | 1 (0.53) | 0 (0.00) | ||
Positive | 407 (79.96) | 199 (75.38) | 181 (95.77) | 27 (48.21) | ||
Unknown | 99 (19.45) | 63 (23.86) | 7 (3.70) | 29 (51.79) | ||
Thyroid nodule | ||||||
Maximum diameter of nodule, M (Q1, Q3) | 1.80 (0.80, 3.40) | 3.00 (1.70, 4.00) | 0.80 (0.60, 1.40) | 1.75 (0.90, 3.15) | Z = 5.137 | < .001 |
Composition, n (%) | - | < 0.001 | ||||
Cystic | 54 (10.61) | 54 (20.45) | 0 (0.00) | 0 (0.00) | ||
Spongy | 4 (0.79) | 4 (1.52) | 0 (0.00) | 0 (0.00) | ||
Solid Cystic | 72 (14.15) | 60 (22.73) | 3 (1.59) | 9 (16.07) | ||
Solid | 379 (74.46) | 146 (55.30) | 186 (98.41) | 47 (83.93) | ||
Echogenicity, n (%) | - | < 0.001 | ||||
Anechoic | 55 (10.81) | 55 (20.83) | 0 (0.00) | 0 (0.00) | ||
Hyperechoic | 86 (16.90) | 80 (30.30) | 4 (2.12) | 2 (3.57) | ||
Hypoechoic | 341 (66.99) | 125 (47.35) | 172 (91.01) | 44 (78.57) | ||
Markedly Hypoechoic | 27 (5.30) | 4 (1.52) | 13 (6.88) | 10 (17.86) | ||
Shape, n (%) | χ2 = 22.950 | < 0.001 | ||||
A/T < 1 | 383 (75.25) | 241 (91.29) | 94 (49.74) | 48 (85.71) | ||
A/T ≥ 1 | 126 (24.75) | 23 (8.71) | 95 (50.26) | 8 (14.29) | ||
Margin, n (%) | χ2 = 7.555 | < 0.001 | ||||
Smooth or unclear | 367 (72.10) | 247 (93.56) | 87 (46.03) | 33 (58.93) | ||
Irregular or lobulated | 107 (21.02) | 17 (6.44) | 78 (41.27) | 12 (21.43) | ||
Extra thyroid extension | 35 (6.88) | 0 (0.00) | 24 (12.70) | 11 (19.64) | ||
Calcification, n (%) | - | < 0.001 | ||||
None | 270 (53.05) | 193 (73.11) | 59 (31.22) | 18 (32.14) | ||
Coarse calcifications | 47 (9.23) | 34 (12.88) | 11 (5.82) | 2 (3.57) | ||
Rim calcifications | 12 (2.36) | 4 (1.52) | 7 (3.70) | 1 (1.79) | ||
Micro calcifications | 180 (35.36) | 33 (12.50) | 59 (31.22) | 18 (32.14) | ||
Metastatic lymph nodes, n (%) | χ2 = 5.825 | < 0.001 | ||||
No | 451 (88.61) | 264 (100.00) | 151 (79.89) | 36 (64.29) | ||
Yes | 58 (11.39) | 0 (0.00) | 38 (20.11) | 20 (35.71) |
Discrimination values of ACR score, ACR TI-RADS and Kwak TI-RADS for malignant and benign nodules
Variable | Total (n = 509) | Groups | Statistical magnitude | P | |
---|---|---|---|---|---|
Benign nodule (n = 264) | Malignant nodule (n = 245) | ||||
ACR score, M (Q1, Q3) | 6 (3, 9) | 3 (2, 5) | 9 (7, 10) | Z = -16.248 | < 0.001 |
ACR TI-RADS, n (%) | Z = -15.471 | < 0.001 | |||
TR1 | 54 (10.61) | 54 (20.45) | 0 (0.00) | ||
TR2 | 30 (5.89) | 29 (10.98) | 1 (0.41) | ||
TR3 | 66 (12.97) | 62 (23.48) | 4 (1.63) | ||
TR4 | 116 (22.79) | 76 (28.79) | 40 (16.33) | ||
TR5 | 243 (47.74) | 43 (16.29) | 200 (81.63) | ||
Kwak TI-RADS, n (%) | Z = -15.956 | < 0.001 | |||
TIRADS 2 | 54 (10.61) | 54 (20.45) | 0 (0.00) | ||
TIRADS 3 | 26 (5.11) | 25 (9.47) | 1 (0.41) | ||
TIRADS 4a | 85 (16.70) | 80 (30.30) | 5 (2.04) | ||
TIRADS 4b | 80 (15.72) | 56 (21.21) | 24 (9.80) | ||
TIRADS 4c | 240 (47.15) | 49 (18.56) | 191 (77.96) | ||
TIRADS 5 | 24 (4.72) | 0 (0.00) | 24 (9.80) |
Tools | AUC area(95%CI) | Cutoff | Sensitivity (95%CI) | Specificity (95%CI) | PPV (95%CI) | NPV (95%CI) | Z | P |
---|---|---|---|---|---|---|---|---|
ACR score | 0.914 (0.886–0.937) | > 5 | 0.935 (0.896–0.962) | 0.765 (0.709–0.815) | 0.787 (0.740–0.834) | 0.927 (0.892–0.961) | 4.176 | < 0.001 |
ACR TI-RADS | 0.871 (0.839–0.899) | > TR4 | 0.816 (0.762–0.863) | 0.837 (0.787–0.880) | 0.823 (0.775–0.871) | 0.831 (0.786–0.876) | 2.319 | 0.020 |
Kwak TI-RADS | 0.885 (0.854–0.911) | > 4b | 0.878 (0.830–0.916) | 0.814 (0.762–0.859) | 0.814 (0.767–0.861) | 0.878 (0.837–0.919) |
Discrimination values of ACR score, ACR TI-RADS and Kwak TI-RADS for PTC or MTC and patients with benign nodules
Variables | Total (n = 509) | Groups | ||
---|---|---|---|---|
Benign nodule (n = 264) | PTC (n = 189) | MTC (n = 56) | ||
ACR score, M(Q1,Q3) | 6 (3,9) | 3 (2,5) | 9 (7,10) | 7 (6,9) |
ACR TI-RADS, n (%) | ||||
TR1 | 54 (10.61) | 54 (20.45) | 0 (0.00) | 0 (0.00) |
TR2 | 30 (5.89) | 29 (10.98) | 0 (0.00) | 1 (1.79) |
TR3 | 66 (12.97) | 62 (23.48) | 0 (0.00) | 4 (7.14) |
TR4 | 116 (22.79) | 76 (28.79) | 27 (14.29) | 13 (23.21) |
TR5 | 243 (47.74) | 43 (16.29) | 162 (85.71) | 38 (67.86) |
Kwak TI-RADS, n(%) | ||||
TI-RADS 2 | 54 (10.61) | 54 (20.45) | 0 (0.00) | 0 (0.00) |
TI-RADS 3 | 26 (5.11) | 25 (9.47) | 0 (0.00) | 1 (1.79) |
TI-RADS 4a | 85 (16.70) | 80 (30.30) | 1 (0.53) | 4 (7.14) |
TI-RADS 4b | 80 (15.72) | 56 (21.21) | 14 (7.41) | 10 (17.86) |
TI-RADS 4c | 240 (47.15) | 49 (18.56) | 153 (80.95) | 38 (67.86) |
TI-RADS 5 | 24 (4.72) | 0 (0.00) | 21 (11.11) | 3 (5.36) |
Variables | AUC (95%CI) | Cutoff | Sensitivity (95%CI) | Specificity (95%CI) | PPV (95%CI) | NPV (95%CI) | Z | P | Z* | P* |
---|---|---|---|---|---|---|---|---|---|---|
ACR scorea | 0.850 (0.811–0.891) | > 5 | 0.839 (0.717–0.924) | 0.765 (0.709–0.815) | 0.431 (0.709–0.815) | 0.957 (0.709–0.815) | 2.404 | 0.016 | ||
ACR TI-RADSa | 0.820 (0.773–0.860) | > TR4 | 0.679 (0.540–0.797) | 0.837 (0.787–0.880) | 0.469 (0.360–0.578) | 0.925 (0.891–0.958) | 1.497 | 0.134 | ||
Kwak TI-RADSa | 0.832 (0.787–0.872) | > 4b | 0.732 (0.597–0.842) | 0.814 (0.762–0.859) | 0.456 (0.353–0.558) | 0.935 (0.903–0.967) | - | - | ||
ACR scoreb | 0.931 (0.904–0.953) | > 5 | 0.963 (0.925–0.985) | 0.765 (0.709–0.815) | 0.746(0.691–0.801) | 0.967(0.942–0.991) | 1.754 | 0.079 | 2.869 | 0.004 |
ACR TI-RADSb | 0.886 (0.853–0.914) | > TR4 | 0.857 (0.799–0.904) | 0.837 (0.787–0.880) | 0.790(0.735–0.846) | 0.891(0.852–0.930) | 0.701 | 0.483 | 2.235 | 0.025 |
Kwak TI-RADSb | 0.900 (0.876–0.925) | > 4b | 0.921 (0.882–0.959) | 0.814 (0.767–0.861) | 0.780(0.726–0.835) | 0.935(0.903–0.967) | - | - |
Discrimination values of ACR score, ACR TI-RADS and Kwak TI-RADS for MTC and PTC
Variables | AUC area (95%CI) | Cutoff | Sensitivity (95%CI) | Specificity (95%CI) | PPV (95%CI) | NPV (95%CI) | Z | P |
---|---|---|---|---|---|---|---|---|
ACR score | 0.650 (0.565–0.734) | ≤ 8 | 0.696 (0.576–0.817) | 0.577 (0.506–0.647) | 0.328 (0.243–0.412) | 0.865 (0.805–0.925) | 0.669 | 0.504 |
ACR TI-RADS | 0.596 (0.527–0.664) | ≤ TR4 | 0.321 (0.199–0.444) | 0.857 (0.807–0.907) | 0.400 (0.257–0.543) | 0.810 (0.756–0.864) | 0.345 | 0.730 |
Kwak TI-RADS | 0.613 (0.545–0.681) | ≤ 4b | 0.268 (0.152–0.384) | 0.921 (0.882–0.959) | 0.500 (0.321–0.679) | 0.809 (0.757–0.862) |