Argenziano 2011.

Study characteristics
Patient sampling	Study design: case‐control Data collection: retrospective Period of data collection: 2006‐2008 Country: Naples, Italy
Patient characteristics and setting	Inclusion criteria: randomly sampled 100 melanomas and 100 excised melanocytic naevi from a digital collection of lesions screened 2006‐2008 at the Department of Dermatology of the Second University of Naples; also randomly sampled 100 melanocytic naevi that showed no relevant changes to warrant excision during the follow‐up period from a larger database of monitored naevi Setting: secondary (general dermatology) Prior testing: retrospective study of a random sample of dermoscopic images collected in departmental database. 100/349 excised melanomas 100/1512 excised naevi Setting for prior testing: NR Exclusion criteria: excluded non‐melanocytic lesions, lesions on certain anatomical sites (facial, acral, mucosal and nail lesions), lesions > 15 mm, and lesions with conflicting histopathological features Sample size (participants): NR Sample size (lesions): number included: 300 Participant characteristics: NR Lesion characteristics: NR
Index tests	Dermoscopy: pattern analysis; 7PCL; revised 7PCL Method of diagnosis: dermoscopic images Prior test data: no further information used; "No additional information was provided, to avoid the possible bias that clinical information may give to the assessment on morphological criteria." Diagnostic threshold: pattern analysis ‐ classify as naevus/melanoma/or lesion to be excised. 7PCL ‐ individual criteria scored. Original 7‐point‐score ≥ 3 merits excision (based on 3 major criteria with 2 points each (atypical network, blue‐white veil and atypical vascular pattern) and 4 minor criteria with 1 point each (irregular dots/globules, irregular streaks, irregular blotches and regression structures). Revised 7PCL: score ≥ 1 merits excision (each criterion is given a score of 1 point) Diagnosis based on: average; (n = 8) Observer qualifications: dermatologist Experience in practice: high; "Experienced dermatologists" Experience with dermoscopy: high; dermatologists specifically trained in dermoscopy
Target condition and reference standard(s)	Reference standard: histological diagnosis + follow‐up; 200/300 had histology. 100/300 were naevi that had been followed up 1‐3 years (median 22 months; range 1‐3 years) Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 100; not clear if in situ included Excised naevi included: 57 Clark naevi, 28 SN, 10 small congenital naevi and 5 blue naevi The remaining 100 monitored lesions were reported as 74 reticular naevi and 26 globular naevi
Flow and timing	Excluded participants: none reported Time interval to reference test: unknown
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?	No
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?	Yes
For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others?	Unclear
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
		Low	High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	No
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
		High	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?	No
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?	Yes
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
		High