Rubegni 2016.

Study characteristics
Patient sampling	Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: 2010–2014 Country: NR. Majority of study authors based in Italy, but source of lesion images not described
Patient characteristics and setting	Inclusion criteria: consecutive melanocytic skin lesions showing clear‐cut dermoscopic features of regression that were excised for suspected malignancy. Regression features included: blue‐grey veil, blue grey globules and white scar‐like areas, hypopigmented areas and atypical network (all of which may be present in benign and malignant lesions) Setting: secondary; not clearly reported but study authors all based in dermatology units or departments Prior testing: dermatoscopic suspicion in all cases Setting for prior testing: NR Exclusion criteria: none reported Sample size (participants): number included: 95 Sample size (lesions): number included: 95 Participant characteristics: median age: naevi group 36 years (14‐59 years); melanoma group 54.4 years (17‐89 years). Male: 43; 45.2% Lesion characteristics: lesion site: head/neck: 20 (40%) of naevi; trunk 23(46%) of naevi and 24 (55%) of melanoma group; extremities 7 (14%) of naevi group; other areas 20 (45%) of melanomas. Lesion size: mean 7.63 mm, range 4‐16 mm (naevi) and 10.33 mm 5‐19 mm (melanomas)
Index tests	Dermoscopy: pattern analysis using 12 dermoscopic features of regression (study also developed a new classifier but data excluded from review, due to use of 'leave one out' procedure for validation) Method of diagnosis: dermoscopic images; randomly presented to observers blinded to histopathological diagnosis Prior test data: unclear; data on morphology, site, age and gender were collected but not clear if presented along with image Diagnostic threshold: diagnosis of melanoma or naevus following assessment of 12 dermoscopic structures suggestive of regression selected according to the literature (Zalaudek 2004; Seidenari 2010) including blue‐grey areas, blue‐whitish veil, blue globules and blue‐grey peppering, white scar‐like areas, white shiny streaks, atypical network, hypopigmented areas, irregular dots and globules, irregular streaks, irregular pigmented blotches and pink areas Diagnosis based on: single observer and consensus of 2/3 (n = 3) Observer qualifications: dermatologist Experience in practice: high; expert dermatologists Experience with dermoscopy: high; "experienced dermoscopists"
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Details: every histological diagnosis was confirmed by 2/3 expert dermopathologists Disease‐positive: 45; disease‐negative: 50 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 45 Benign naevus: 50
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?	Yes
Are the included patients and chosen study setting appropriate?	No
Did the study avoid including participants with multiple lesions?	Yes
		Low	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?
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?	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