Carli 2002a.

Study characteristics
Patient sampling	Study design: case series Data collection: prospective for clinical examination and in‐vivo dermoscopy; retrospective image selection/prospective interpretation for ex‐vivo dermoscopic evaluation Period of data collection: June 1997‐December 1998 Country: Italy
Patient characteristics and setting	Inclusion criteria: clinically equivocal and suspicious PSLs subjected to excisional biopsy at the Institute of Dermatology Setting: secondary (not further specified) Prior testing: clinical and/or dermatoscopic suspicion Setting for prior testing: secondary Exclusion criteria: none reported Sample size (participants): NR Sample size (lesions): 256 Participant characteristics: none reported Lesion characteristics: of the cutaneous melanomas, 14 (25.9%) were in situ melanoma (Clark level I), 18 (33.3%) were invasive with < 0.75 mm thickness, 19 (35.3%) were of intermediate thickness (0.76–1.50 mm) and 3 (5.5%) were > 1.5 mm. The median thickness of invasive melanomas was 0.94 mm ± 0.5 (SD) (range 0.2–6)
Index tests	VI: no algorithm Method of diagnosis: in‐person diagnosis Prior test data: unclear Diagnostic threshold: NR Diagnosis based on: consensus (2 observers); final clinical diagnosis was based on agreement between the 2 observers. In case of disagreement, the opinion of a 3rd observer was considered to be the judge for the diagnosis Observer qualifications: dermatologist Experience in practice: high experience or ‘Expert’; described as “dermatologists with extensive experience in both clinical and dermoscopic diagnosis of pigmented skin lesions” Experience with dermoscopy: high experience /‘Expert’ users Dermoscopy: pattern analysis Method of diagnosis: in‐person diagnosis and image‐based diagnosis. Clinical examination and in vivo dermoscopy were performed before excision by 2 trained dermatologists and diagnosis reached. Dermoscopic images were re‐analysed by the same 2 observers at the end of the inclusion period (December 1998), blind to the previous clinical and histological diagnoses Prior test data: N/A for in‐person; for image‐based: slides of dermoscopic images were evaluated using a viewer that made it impossible to analyse the clinical features of the lesion; both observers had access to clinical information, including the age of the participant, the site of the lesion, the history of change over time as reported by the participant at the time of in vivo examination. Diagnostic threshold: dermoscopic diagnosis was based on the ELM pattern analysis criteria, using the same diagnostic categories used for clinical diagnosis; characteristics investigated included pigment network, pigmentation, hypopigmentation, brown globules, black dots, pseudopods, radial streaming, grey‐blue veil, atypical vascular pattern Test observers as described for VI (above)
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Target condition (final diagnoses) Melanoma (invasive): 40; melanoma (in situ): 14 BCC: 5 Sebhorrheic keratosis: 4; Benign naevus: 90 common melanocytic naevi; 78 melanocytic naevi; 9 blue naevi; 16 SN/ Reed naevi
Flow and timing	Excluded participants: none reported Time interval to reference test: NR
Comparative	Blinding between tests: In‐person clinical examination and dermoscopy Time interval between index test(s): the interval between in vivo dermoscopy and re‐evaluation of dermoscopic images was reported as 1 year
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?	Unclear
		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?	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
		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?	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	Low
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?	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