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

Seidenari 2007.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR
Country: Italy
Test set derived NR; the training set consisted of 369 melanocytic lesion images (including 43 MMs); test set comprised 243 images (including 43 MMs)
Patient characteristics and setting Inclusion criteria: dermoscopic images of melanocytic lesion that had undergone excision
Setting: unclear
Prior testing: selected for excision (no further detail)
Setting for prior testing: unspecified
Exclusion criteria: none reported
Sample size (participants): NR
Sample size (lesions): number eligible: 612; number included: 243 in test set
Participant characteristics: none reported
Lesion characteristics: MMs of the test set included 8 in situ with mean thickness 0.77 mm
Index tests Dermoscopy: no algorithm
Method of diagnosis: dermoscopic images observed on a computer screen
Prior test data: no further information used; clinicians had no access to the clinical image or to clinical data
Diagnostic threshold: clinical diagnosis of melanoma
Diagnosis based on: single observer (n = 4; results presented per observer, but not identifiable by experience level)
Observer qualifications: dermatology registrar (n = 3); dermatologist (n = 1)
Experience in practice: NR
Experience with dermoscopy: mixed: trained (residents had undergone 6‐month daily training on dermoscopy); high (dermatologist employed dermoscopy on a regular basis)
Target condition and reference standard(s) Reference standard: histological diagnosis alone (no further details)
Disease‐positive: 43; disease‐negative: 200
Target condition (final diagnoses)
Melanoma (invasive): 35; melanoma (in situ): 8
Benign naevus: 200
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? Unclear    
    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? 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