Summary of findings'. 'Summary of findings table.
Question | What is the diagnostic accuracy of dermoscopy, in comparison to visual inspection, for the detection of cutaneous invasive melanoma and atypical intraepidermal melanocytic variantsin adults? | |||||||
Population | Adults with lesions suspicious for melanoma, including:
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Index test | Dermoscopy with or without the use of any established algorithms or checklist to aid diagnosis, including:
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Comparator test | Visual inspection | |||||||
Target condition | Cutaneous invasive melanoma and atypical intraepidermal melanocytic variants | |||||||
Reference standard | Histology with or without follow‐up to confirm absence of malignancy in benign‐appearing lesions | |||||||
Action | If accurate, positive results ensure melanoma lesions are not missed but are appropriately excised (or referred), and those with negative results can be safely reassured and discharged. | |||||||
Number of studies | Total lesions | Total melanomas | ||||||
Quantity of evidence | 104 | 42,788 | 5700 | |||||
Limitations | ||||||||
Risk of bias (in‐person; image‐based) |
Potential risk for participant selection from use of case‐control type design (19 image‐based), inappropriate exclusion criteria (8; 25), or lack of detail (17; 27). All dermoscopy interpretation was blinded to reference standard diagnosis. Dermoscopy thresholds were clearly pre‐specified (25; 50). Low risk for reference standard (29; 63); high risk from use of expert diagnosis or > 20% of benign lesions with no histology (5; 11). Blinding of reference standard to clinical diagnosis reported only in one image‐based evaluation. High risk for participant flow (15; 26), due to differential verification (6; 15), and exclusions following recruitment (10; 16). Timing of tests was not mentioned in 23 (18). | |||||||
Applicability of evidence to question (in‐person; image‐based) |
Participants restricted to those with melanocytic lesions only (10; 35), or other narrowly defined groups (5 image‐based), or to those with histopathology results (29; 57), and included multiple lesions per participant (8 in‐person). High concern for dermoscopy (16; 57), with no description of diagnostic thresholds (8; 25), or reporting of average or consensus diagnoses (9; 35). Dermoscopic image interpretation blinded to clinical images (51 image‐based). Little information given concerning the expertise of the histopathologist (28; 50). | |||||||
Findings | ||||||||
We included 104 study publications (providing data for 103 cohorts of lesions). We separated a priori 83 publications providing 86 datasets for evaluation of the primary target condition into in‐person (n = 26), and image‐based (n = 60), evaluations. Subsequent analysis confirmed differences in accuracy according to the different approaches to diagnosis (P < 0.0001). Analyses of studies by degree of prior testing revealed no obvious effect on accuracy; the study publications provided insufficient relevant information, and the majority of studies were apparently conducted in referred populations, which hampered our analyses. The findings presented are based on results for all studies regardless of position on the clinical pathway. Sensitivities at fixed specificities and specificities at fixed sensitivities are given for illustrative purposes only and should not be taken as indicative of actual test performance. | ||||||||
Test | In‐person visual inspection alone versus visual inspection plus dermoscopy: any algorithm or threshold | |||||||
Data analysed | Visual inspection | 13 datasets; 6740 lesions; 459 cases | ||||||
Dermoscopy | 26 datasets; 23,169 lesions; 1664 cases | |||||||
Resultsa | Sensitivity (95% CI) % | Fixed specificity | Fixed sensitivity | Specificity (95% CI) % | ||||
Visual inspection | 76% (66 to 85) | 80% | 80% | 75% (57 to 87) | ||||
Dermoscopy | 92% (87 to 95) | 95% (90 to 98) | ||||||
Numbers applied to a hypothetical cohort of 1000 lesionsb | ||||||||
TP | FN | FP | TN | TP | FN | FP | TN | |
At a prevalence of 5% | VI: 38 D: 46 ↑ 8 |
VI: 12 D: 4 ↓ 8 |
190 | 760 | 40 | 10 | VI: 238 D: 47 ↓191 |
VI: 713 D: 904 ↑191 |
At a prevalence of 12% | VI: 91 D: 110 ↑19 |
VI: 29 D: 10 ↓ 19 |
176 | 704 | 96 | 24 | VI: 220 D: 44 ↓176 |
VI: 660 D: 836 ↑176 |
At a prevalence of 21% | VI: 160 D: 193 ↑ 33 |
VI: 50 D: 17 ↓ 33 |
158 | 632 | 168 | 42 | VI: 198 D: 40 ↓158 |
VI: 5935 D: 750 ↑158 |
Test: | Image‐based visual inspection alone versus visual inspection plus dermoscopy: any algorithm or threshold | |||||||
Data analysed | Visual inspection | 11 datasets; 1740 lesions; 305 cases | ||||||
Dermoscopy | 60 datasets; 13475 lesions; 2851 cases | |||||||
Results | Sensitivity (95% CI) % | Fixed specificity | Fixed sensitivity | Specificity (95% CI) % | ||||
Visual inspection | 47% (34 to 59) | 80% | 80% | 42% (28 to 58) | ||||
Dermoscopy | 81% (76 to 86) | 82% (75 to 87) | ||||||
Numbers applied to a hypothetical cohort of 1000 lesionsc | ||||||||
TP | FN | FP | TN | TP | FN | FP | TN | |
At a prevalence of 18% | VI: 85 D: 146 ↑ 61 |
VI: 95 D: 34 ↓ 61 |
164 | 656 | 144 | 36 | VI: 476 D: 148 ↓328 |
VI: 344 D: 672 ↑328 |
At a prevalence of 24% | VI: 113 D: 194 ↑81 |
VI: 127 D: 46 ↓ 81 |
152 | 608 | 192 | 48 | VI: 441 D: 137 ↓304 |
VI: 319 D: 623 ↑304 |
At a prevalence of 39% | VI: 183 D: 316 ↑ 133 |
VI: 207 D: 74 ↓ 133 |
122 | 488 | 312 | 78 | VI: 354 D: 110 ↓244 |
VI: 256 D: 500 ↑244 |
Test | Results according to algorithm used to assist dermoscopy interpretation | |||||||
Datasets | Lesions; cases |
Sensitivity (95% CIs) % |
Specificity (95% CI) % |
Numbers in a cohort of 1000 lesionsd | ||||
TP | FN | FP | TN | |||||
In‐person | At median prevalence of 12% | |||||||
No algorithm | 8 | 4704; 849 | 88% (75 to 95) |
87% (80 to 92) |
106 | 14 | 114 | 766 |
Pattern analysis | 6 | 4307; 296 | 92% (87 to 95) |
92% (68 to 98) |
110 | 10 | 70 | 810 |
ABCD at > 5.45 (or likely) | 5 | 1438; 160 | 81% (62 to 92) |
92% (82 to 97) |
97 | 235 | 70 | 810 |
Image‐based | At median prevalence of 24% | |||||||
No algorithm | 24 | 4498; 941 | 76% (70 to 82) |
79% (71 to 85) |
182 | 58 | 61 | 699 |
Pattern analysis | 20 | 4621; 989 | 83% (76 to 88) |
87% (80 to 92) |
199 | 41 | 99 | 661 |
ABCD at > 5.45 | 7 | 2471; 406 | 81% (60 to 92) |
81% (69 to 89) |
194 | 46 | 144 | 616 |
7PCL at ≥ 3 | 11 | 3408; 798 | 80% (63 to 91) |
67% (51 to 80) |
192 | 48 | 251 | 509 |
3PCL | 7 | 1505; 363 | 74% (61 to 85) |
60% (42 to 76) |
178 | 62 | 304 | 456 |
3PCL: three‐point checklist; 7PCL: seven‐point checklist; ABCD(E): asymmetry, border, colour, differential structures (enlargement); CI: confidence interval; D: dermoscopy; FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive; VI: visual inspection |
aNumbers for a hypothetical cohort of 1000 lesions are presented for two illustrative examples of points on the SROC curves: firstly for the sensitivities of tests at fixed specificities of 80%; and secondly for the specificities of tests at fixed sensitivities of 80%. bNumbers estimated at 25th, 50th (median), and 75% percentiles of invasive melanoma or atypical intraepidermal melanocytic variants prevalence observed across 26 datasets reporting in‐person evaluations of dermoscopy added to visual inspection. cNumbers estimated at 25th, 50th (median), and 75% percentiles of invasive melanoma or atypical intraepidermal melanocytic variants prevalence observed across 60 datasets reporting diagnosis using dermoscopic images dNumbers estimated at median prevalence (50th percentile), of invasive melanoma or atypical intraepidermal melanocytic variants observed across 26 datasets reporting in‐person evaluations of dermoscopy added to visual inspection and then for 60 datasets reporting diagnosis using dermoscopic images