1. Primary analyses for detection of invasive melanoma or atypical intraepidermal melanocytic variants by position on the clinical pathway.
| In‐person evaluations (n = 28) | ||||||
| Position on pathway | Datasets | Lesions (melanomas) |
Sensitivity % (95% CI %) |
Variance |
Specificity % (95% CI %) |
Variance |
| Participants with limited prior testing (unselected on reference standard) | ||||||
| Clear | 3 | 1339 (55) |
92.4 (26.2 to 99.8) |
6.26 |
79.7 (73.7 to 84.7) |
0.07 |
| Participants with limited prior testing (selected for excision) | ||||||
| Clear | 2a | 4228 (160) |
90.1 (70.0 to 97.3) |
0.53 |
81.3 (67.5 to 90.0) |
0.25 |
| Unclear | 1 | 353 (38) | 78.9 (62.7 to 90.4) |
‐ | 94.0 (90.7 to 96.3) |
‐ |
| Combined | 3 | 4581 (198) | 87.2 (73.2 to 94.4) |
0.45 | 87.1 (74.6 to 94.0) |
0.51 |
| Referred participants (unselected on reference standard) | ||||||
| Clear | 2 | 3494 (61) |
74.6 (48.9 to 90.0) |
0.14 |
98.6 (94.7 to 99.6) |
0.77 |
| Referred participants (selected for excision) | ||||||
| Clear | 8 | 5331 (258) |
76.7 (61.7 to 87.1) |
0.78 |
95.7 (89.7 to 98.3) |
1.73 |
| Unclear | 9 | 9611 (1015) | 82.8 (74.4 to 88.9) |
0.34 | 89.2 (71.1 to 96.5) |
3.21 |
| Combined | 17 | 14942 (1273) |
79.7 (71.7 to 85.8) |
0.59 | 93.0 (85.4 to 96.8) |
2.59 |
| Referred participants with equivocal lesions (selected for excision) | ||||||
| Clear | 2a | 930 (88) |
84.7 (55.5 to 96.1) |
0.93 |
89.5 (79.5 to 95.0) |
0.27 |
| Unclear | 1 | 318 (73) | 61.4 (49.0 to 72.9) |
‐ | 87.3 (82.5 to 91.2) |
‐ |
| Combined | 3 | 1248 (161) | 76.4 (48.4 to 91.8) |
1.03 | 88.8 (81.8 to 93.3) |
0.21 |
| b. Image‐based evaluations (n = 11) | ||||||
| Position on pathway | Datasets | Lesions (melanomas) |
Sensitivity (95% CI %) |
Variance |
Specificity (95% CI %) |
Variance |
| Participants with limited prior testing (selected for excision) | ||||||
| Clear | 1 | 50 (9) |
22.2 (2.8 to 60.0) |
‐ |
70.7 (54.4 to 83.9) |
‐ |
| Unclear | 1 | 463 (29) | 20.7 (8.0 to 39.7) |
‐ | 96.8 (94.6 to 98.2) |
‐ |
| Combined | 2 | 513 (38) | 21.4 (10.0 to 40.1) |
0 | 90.9 (60.7 to 98.1) |
1.50 |
| Referred participants (unselected on reference standard) | ||||||
| Clear | 1 | 134 (31) |
74.2 (55.4 to 88.1) |
‐ |
82.5 (73.8 to 89.3) |
1 |
| Referred participants (selected for excision) | ||||||
| Unclear | 6 | 293 (96) | 60.3 (49.2 to 70.5) |
0.02 | 77.0 (63.9 to 86.4) |
0.40 |
| Referred participants with equivocal lesions (selected for excision) | ||||||
| Unclear | 2 | 303 (98) | 61.9 (46.7 to 75.0) |
0.10 | 81.8 (75.2 to 87.0) |
0.01 |
| CI: confidence interval | ||||||
aSensitivity and specificity estimated independently in separate models due to sparse data.