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

Sboner 2004.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR
Country: Italy (based on authors' institution)
Patient characteristics and setting Inclusion criteria: melanocytic lesion images acquired consecutively by d‐ELM at the Department of Dermatology of Santa Chiara Hospital, Trento
Setting: secondary (general dermatology)
Prior testing: selected for excision (no further detail)
Setting for prior testing: NR
Exclusion criteria: seems that dysplastic naevi were excluded; "In this experimental setting, there were no dysplastic naevi"
Sample size (participants): NR
Sample size (lesions): number included: 152
Participant characteristics: none reported
Lesion characteristics: mean Breslow thickness for the invasive lesions is 1.0 +/‐ 0.7 mm; 81% ≤ 1.5 mm
Index tests Dermoscopy: no algorithm
Method of diagnosis: dermoscopic images; digitial‐ELM images presented on video device
Prior test data: no further information used
Diagnostic threshold: NR; appears to be correct diagnosis of melanoma
Diagnosis based on: single observer and average (n = 8)
 Observer qualifications: dermatologist
Experience in practice: not described
Experience with dermoscopy: not described
Any other detail: the d‐ELM Image Acquisition consists of a Leica WILD M‐650 stereomicroscope (Leica Microsystem, Heerbrugg, Switzerland), with a SONY 3CCD DXC‐930P colour camera (Sony Corporation,Tokyo, Japan). The software for image acquisition was DBDERMO MIPS (Dell’Eva/Burroni Studio, Florence/Siena, Italy). The digital image size has a spatial resolution of 768 x 576 pixels and a 24‐bit colour resolution
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Disease‐positive: 42; disease‐negative: 110
Target condition (final diagnoses)
Melanoma (invasive): 31; melanoma (in situ): 11
Benign naevus: 110
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? 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? Unclear    
    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? 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