de Giorgi 2012.

Study characteristics
Patient sampling	Study design: CS Data collection: retrospective image selection/prospective interpretation Period of data collection: October 2006‐September 2010 Country: Italy
Patient characteristics and setting	Inclusion criteria: pigmented melanocytic skin lesions with a maximum diameter of 6 mm excised at Deptartment of Dermatology Setting: secondary (general dermatology) Prior testing: NR Setting for prior testing: NR Exclusion criteria: location/site of lesion ‐ palmar and plantar regions, mucosal lesions and pigmented melanocytic lesions of the nails excluded Sample size (participants): NR Sample size (lesions): number included: 103 Participant characteristics: mean age: melanoma group male (50.4 years) female (48.4 years); benign group male (36 years) female (36.8 years) Lesion characteristics: head/neck: 3; trunk: 21; upper limbs/shoulder: 16; lower limbs/hip: 26; back = 34; dorsal acral = 3. Thickness: ≤ 1 mm 15; > 1 mm = 1 MM
Index tests	VI: ABCD Method of diagnosis: clinical photographs Prior test data: unclear Other test data: dermoscopic images also presented separately to observer (only presence/absence of particular dermoscopic features recorded; not an overall diagnostic assessment) Diagnostic threshold: ABCD criteria ≥ 2 criteria present Diagnosis based on: consensus (3 observers); n = 3 Observer qualifications: dermatologist Experience in practice: high experience or ‘Expert’; quote: “the four dermatologists had the same level of training and experience in dermatology, with more than 5 years of practice in dermoscopy”
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Disease positive: 34; disease negative: 69 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 34 'Benign' diagnoses: 69 benign melanocytic nevus
Flow and timing	Excluded participants: none reported 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?	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 Visual inspection ‐ 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?	No
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?	Yes
		High	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