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. 2018 Dec 4;2018(12):CD011902. doi: 10.1002/14651858.CD011902.pub2

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:
  • those with limited prior testing (presenting in primary, community or private dermatology settings), and

  • referred populations (presenting in secondary care or specialist skin cancer clinics).

Index test Dermoscopy with or without the use of any established algorithms or checklist to aid diagnosis, including:
  • in‐person evaluations (face‐to‐face diagnosis), and

  • image‐based evaluations (diagnosis based on assessment of a clinical image).

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