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

Gilmore 2010.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: 2003‐2008
Country: Austria
Test set derived: NR. Training set: 65 melanomas and 65 dysplastic naevi, test set: 36 melanomas and 33 dysplastic naevi (included in review)
Patient characteristics and setting Inclusion criteria: atypical melanocytic lesions with polarised dermoscopic images; describes database as a "random, but representative, cohort" but does not describe method of selection
Setting: secondary (general dermatology)
Prior testing: unclear
Setting for prior testing: NR
Exclusion criteria: none reported
Sample size (participants): number included: NR
Sample size (lesions): number included: 199: derivation set n = 130; test set n = 69
Participant characteristics: none reported
Lesion characteristics: none reported
Index tests Dermoscopy: no algorithm
Method of diagnosis: dermoscopic images
Prior test data: no further information used; described as blinded assessment
Diagnostic threshold: NR; subjective impression; excise or not
Diagnosis based on: single observer (n = 1)
Observer qualifications: dermatologist
Experience in practice: not described
Experience with dermoscopy: not described; implies high or expert assessment. Conducted by 1 of the co‐authors
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Details: "lesions were excised and examined microscopically by expert dermatopathologists using standard: histopathologic diagnostic criteria"
Disease‐positive: 36 = test set and 65 = derivation set; disease‐negative: 33 = test set and 65 = derivation set
Target condition (final diagnoses)
Melanoma (in situ and invasive, or NR): 36 test set and 65 derivation set
Dysplastic naevi: 33 test set and 65 derivation set
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? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
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? Unclear    
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? No    
Was the test interpretation carried out by an experienced examiner? Yes    
    Unclear 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? 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