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

di Meo 2016.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: February‐December 2014
Country: Italy
Patient characteristics and setting Inclusion criteria: melanocytic skin lesions that underwent excision
Setting: secondary (general dermatology)
Prior testing: selected for excision (no further detail)
Setting for prior testing: secondary (general dermatology)
Exclusion criteria: acral and mucosal lesions; dysplastic naevi excluded; disagreement between evaluators on tumour histological classification ‐ lesions that did not meet at least 2 consents were excluded; poor‐quality index test image (considered under flow and timing)
Sample size (participants): number included: 125
Sample size (lesions): number included: 125
Participant characteristics: mean age: men 44.6 years; women 50.0 years; male: 61; 58%
 Lesion characteristics: thickness ≤ 1 mm: all 32 melanomas
Index tests Dermoscopy 3PCL; scored 3‐point '4‐point checklist' (authors' own scoring); CASH algorithm
Method of diagnosis: dermoscopic images
Prior test data: no further information used
Diagnostic threshold: 3PCL ≥ 2 criteria present; CASH score > 7; 4‐point checklist > 2
Diagnosis based on: unclear; lesions were "randomly assessed by two independent dermatologists" not clear if average or consensus; n = 2
Observer qualifications: dermatologist
Experience in practice: high
Experience with dermoscopy: high; dermatologists with > 7 years of experience in dermoscopy
Any other detail:
The 3PCL criteria: asymmetry in colour and/or structures in 1/2 axes, pigmented network with thickened lines and irregular distribution, and any blue and/or white structure within the lesion
CASH algorithm has 4 criteria: colour, architectural disorder, symmetry and homo/heterogeneity. Scoring described in detail
4‐point checklist; doubled all 3 criteria of the 3PCL and chose the one conferring more sensitivity, specificity and accuracy (symmetry parameter doubled)
Target condition and reference standard(s) Reference standard: histological diagnosis alone
All lesions were excised and independently analysed by 2 dermatopathologists. The diagnosis of dysplastic naevus was based on the histopathological diagnostic criteria set by the World Health Organization Melanoma Programme (Clemente 1991). It was considered as a benign lesion
 Disease‐positive: 32; disease‐negative: 93
Target condition (final diagnoses)
Melanoma (in situ and invasive, or NR): 32
Mild/moderate dysplasia: 50; benign naevus: 43
Flow and timing Excluded participants: dysplastic naevi (n = 50) excluded from 2x2; poor‐quality index test images ‐ exclusion criterion
Interval between index and reference standard: not clearly described
Comparative  
Notes
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? No    
Are the included patients and chosen study setting appropriate? No    
Did the study avoid including participants with multiple lesions? Yes    
    High High
DOMAIN 2: Index Test Dermoscopy ‐ image‐based
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Yes    
For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others? Unclear    
Was the test applied and interpreted in a clinically applicable manner? No    
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? Yes    
Was the test interpretation carried out by an experienced examiner? Yes    
    Low High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
Expert opinion (with no histological confirmation) was not used as a reference standard Yes    
Was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? Yes    
    Low Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? No    
If the reference standard includes clinical follow‐up of borderline/benign appearing lesions, was there a minimum follow‐up following application of index test(s) of at least: 3 months for melanoma or cSCC or 6 months for BCC?      
If more than one algorithm was evaluated for the same test, was the interval between application of the different algorithms 1 month or less? Yes    
    High