Carli 1994.

Study characteristics
Patient sampling	Study design: case series Data collection: unclear Period of data collection: November 1993‐May 1994 Country: Italy
Patient characteristics and setting	Inclusion criteria: clinically suspicious melanocytic lesions undergoing excision for diagnostic purposes Setting: secondary (general dermatology) Prior testing: clinical suspicion of malignancy based on: recent lesion changes or presence of at least two of: diameter > 6 mm, asymmetric, irregular feathery edges, uneven or "very" dark colour, "increased or disappearance of skin outline" Setting for prior testing: secondary (general dermatology) Exclusion criteria: clinically obvious melanomas excluded Sample size (participants): number included: 67 Sample size (lesions): number included: 67 Participant characteristics: mean age 36 years; median age 33; all > 20 years; male: 31% Lesion characteristics: none reported
Index tests	Dermoscopy: pattern analysis; criteria derived from a number of other studies (citations include Steiner 1993, Pehamberger 1987, Steiner 1987, Nachbar 1994, Bahmer 1990, Kenet 1993, Stolz 1989, Soyer 1987, Dal Pozzo 1994) Method of diagnosis: in‐person diagnosis Prior test data: clinical examination Diagnostic threshold: a pigment network that was irregular, accentuated, wide‐meshed, with distinct borders, + at least one of the following parameters: inhomogeneous depigmentation present at the periphery; presence of unevenly distributed black dots; uneven brown globules, with irregular distribution; presence of radial streaks; presence of pseudopods; the presence of grey‐blue veil Diagnosis based on: consensus (2 observers); n = 2 Observer qualifications: NR; likely dermatologist Experience in practice: high; described as "two experienced observers" Experience with dermoscopy: high; as above
Target condition and reference standard(s)	Reference standard: histology (not further described) Disease‐positive: 5; disease‐negative: 63 Target condition (final diagnoses) Melanoma (invasive): 3; melanoma (in situ): 2 'Benign' diagnoses: atypical melanocytic hyperplasia 2; naevi with architectural atypia 14; naevi with ‘cyto’‐architectural atypia 7; no atypia 40
Flow and timing	Participant exclusions: none reported Time interval to reference test: ELM performed at the time of excision of the lesion
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 ‐ in‐person
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?	Unclear
		Low	Unclear
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
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?
		Low