Soyer 2004.

Study characteristics
Patient sampling	Study design: case series Data collection: retrospective (for expert observer data; previously acquired images prospectively interpreted by 6 inexperienced observers ‐ data excluded as 3/6 medical students) Period of data collection: January‐December 2000 Country: Italy
Patient characteristics and setting	Inclusion criteria: lesions at pigmented lesion clinic considered by experienced dermatologists to merit excision on clinical grounds Setting: specialist unit Prior testing: clinical and/or dermatoscopic suspicion Setting for prior testing: specialist unit Exclusion criteria: none reported Sample size (participants): number included: 225 Sample size (lesions): number included: 231 Participant characteristics: median age 34 years. Male: 110/225 (48.9%) Lesion characteristics: none reported
Index tests	Dermoscopy: no algorithm (study also develops 3PCL but data ineligible due to use of medical student observers) Method of diagnosis: in‐person Prior test data: clinical examination Diagnostic threshold: diagnosis of malignancy (melanoma or BCC) Diagnosis based on: single observer (n = 1) Observer qualifications: dermatologist Experience in practice: high; "experienced dermatologists" Experience with dermoscopy: high; "Each lesion was diagnosed dermoscopically by an experienced dermoscopist"
Target condition and reference standard(s)	Reference standard: histological diagnosis alone (not further described) Disease‐positive: 77; disease‐negative: 154 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 68 BCC: 9 'Benign' diagnoses: 154
Flow and timing	Participant exclusions: none reported Index test to reference standard interval: appears consecutive; "before excision, each lesion was diagnosed dermoscopically"
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?	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?	Unclear
Was the test interpretation carried out by an experienced examiner?	Yes
		Unclear	Unclear
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