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

Menzies 1996.

Study characteristics
Patient sampling Study design: unclear. Abstract describes including a random sample of excised lesions from a larger database
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR
Country: Australia
Test set derived: NR; describes 'division' into a training set and a test set
Patient characteristics and setting Inclusion criteria: PSLs from the Sydney Melanoma Unit with dermoscopic images and histological diagnoses; melanomas and randomly selected clinically atypical non‐melanoma lesions were included
Setting: specialist unit (skin cancer/PLC)
Prior testing: selected for excision
Setting for prior testing: specialist unit (skin cancer/PLC)
Exclusion criteria: unequivocal non‐melanoma excluded
Sample size (participants): number included: NR
Sample size (lesions): number included: 385
Participant characteristics: none reported
Lesion characteristics: none reported
Index tests Dermoscopy: Menzies criteria
Method of diagnosis: dermoscopic images
Prior test data: no further information used
Diagnostic threshold: presence of 2 negative features and at least 1 positive feature. Negative features: point and axial symmetry of pigmentation or presence of only a single colour. Positive features of melanoma: multiple (5‐6) colours; blue‐white veil; multiple brown dots; multiple blue/grey; peripheral black dots or globules; a broadened network; pseudopods; radial streaming; scar‐like
Diagnosis based on: unclear (n = NR)
Observer qualifications: NR; likely dermatologists
Experience in practice: not described
Experience with dermoscopy: not described
Target condition and reference standard(s) Reference standard: histological diagnosis alone (not further described)
Disease‐positive: 107; disease‐negative: 278
Target condition (final diagnoses)
Melanoma (invasive): 107; BCC: 18
Ephelis/lentigo 17; SK: 23; benign acquired naevi ‐ 58; dysplastic naevi ‐ 105; blue naevi 11; SN 6; spindle cell naevus 2; DF 2; hemangioma 13; solar keratosis 9; other 14
Flow and timing Participant exclusions: none reported
Index test to reference standard interval: not 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? Unclear    
Did the study avoid inappropriate exclusions? Yes    
Are the included patients and chosen study setting appropriate? No    
Did the study avoid including participants with multiple lesions? Unclear    
    Unclear 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?      
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? Unclear    
    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? Unclear    
    Low Unclear
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? Yes    
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?      
    Unclear