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

Piccolo 2002a.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR; 6‐month period
Country: Italy
Patient characteristics and setting Inclusion criteria: pigmented lesions excised because of equivocal dermoscopic findings or at the patient’s request
Setting: secondary (general dermatology); from authors' institution
Prior testing: dermatoscopic suspicion; patient request for evaluation/excision
Setting for prior testing: NR
Exclusion criteria: none reported
Sample size (participants): number included: 289
Sample size (lesions): number included: 341
Participant characteristics: mean age 33.6 years, range 3–83 years; male: 127 (43.9%); Fitzpatrick phototype I‐II (31.4%); type III (42%); type IV‐V (26.4%)
Lesion characteristics: none reported
Index tests Dermoscopy: no algorithm
Method of diagnosis: clinical photographs and dermoscopic images. Cases were clinically and dermoscopically evaluated on a high‐resolution colour monitor, in a random sequence
Prior test data: none; appears to be based on images only
Diagnostic threshold: correct diagnosis of melanoma
Diagnosis based on: single observer (n = 2)
Observer qualifications: dermatologist; (dermatology?) resident
Experience in practice: high, dermatologist had 5 years of experience; low, resident with minimal training in PSLs
Experience with dermoscopy: high and low (resident had 6 months of experience, comprising 8 h of specialised training on 3 consecutive days and 2 h/week in routine dermoscopy)
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Details: "All excised lesions were examined histopathologically by a dermatopathologist"
Disease‐positive: 13; disease‐negative: 328
Target condition (final diagnoses)
Melanoma (in situ and invasive, or NR): 13
Sebhorrheic keratosis: 3; benign naevus: 316; dFs 7; angiomas 2
Flow and timing Time interval to reference test: NR
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? No    
    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? Unclear    
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