Bono 2002a.

Study characteristics
Patient sampling	Study design: case series Data collection: prospective Period of data collection: June 1998‐March 2000 Country: Italy Test set derived: a training set was separately derived using data obtained from 237 previously studied lesions (Farina 2000)
Patient characteristics and setting	Inclusion criteria: cutaneous pigmented lesions with clinical and/or dermatoscopic features that suggested a more or less important suspicion for CM Setting: specialist unit (skin cancer/PLC) Prior testing: clinical and/or dermatoscopic suspicion Setting for prior testing: specialist unit (skin cancer/PLC) Exclusion criteria: location/site of lesion ‐ awkwardly situated lesions e.g. interdigital space, ears, nose or eyelids. Lesions on scalp excluded due to hair interference with reflectance; lesion size obvious large, thick melanomas Sample size (participants): number included: 298 Sample size (lesions): number included: 313 Participant characteristics: mean age: 40 years (10‐86 years); male: 122; 41% Lesion characteristics: lesion site: head/neck 3%; trunk 61%; limbs 36%; thickness ≤ 1 mm 70% (46/66); for 55 invasive MM: median thickness 0.64 mm, range 0.17‐3.24 mm. Median diameter: 11 mm (3‐31 mm)
Index tests	VI: no algorithm (training in the unit is based on ABCD but subjective experience of the clinician used for diagnosis) Method of diagnosis: in‐person diagnosis Prior test data: N/A in‐person diagnosis Diagnostic threshold: clinical diagnostic criteria based on subjective experience; emphasise lesion colour over dimensions. Diagnosis of suspect CM made when the level of suspicion was "roughly 50% or more". ABCD criteria have been the basis of training at the unit, but is not implemented in diagnosis; preferred emphasis on colour rather than dimensional character Diagnosis based on: single observer; (n = 1) Observer qualifications: surgical oncologists Experience in practice: high experience or ‘Expert’; > 5 years Experience with dermoscopy: assumed high experience; > 5 years Dermoscopy: no algorithm Method of diagnosis: in‐person diagnosis Prior test data: clinical examination and/or case notes Diagnostic threshold: presence of at least one of the following criterion: radial streaming, pseudopods, grey‐blue veil, regression and erythema, whitish veil, black dots at the periphery (if network present), thick irregular network or milky‐red background with red dots Test observers as described for VI (above) Dermatoscopy performed by a hand‐held monocular microscope equipped with an achromatic lens permitting a magnification of x10 (Heine Delta 10)
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Target condition (final diagnoses) Melanoma (invasive): 55; melanoma (in situ): 11; BCC: 6 'Benign' diagnoses: 241;151 compound naevus, 24 junctional naevus, 12 dermal naevus, 12 LS, 10 dysplastic naevus, 8 spindle‐cell naevus, 8 SK, 5 blue naevus, 3 SN, 8 other
Flow and timing	Excluded participants: NR Interval between index and reference: NR
Comparative	Blinding between tests: same clinician undertook both diagnoses (in‐person) Time interval between index test(s): appears consecutive but not fully clear
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?	Unclear
Are the included patients and chosen study setting appropriate?	No
Did the study avoid including participants with multiple lesions?	Yes
		Unclear	High
DOMAIN 2: Index Test Visual Inspection ‐ 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?	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?	Yes
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 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?	Yes
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	Low
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?	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
DOMAIN 5: Comparative
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies?	No
Was the interval between application of the index tests less than one month?	Yes
Were all tests applied and interpreted in a clinically applicable manner?	No
		Low	High