Guitera 2009a (Modena).

Study characteristics
Patient sampling	Study design: case series Data collection: prospective Period of data collection: September 2004‐August 2007 Country: Italy (and Australia ‐ see Guitera 2009b (Sydney))
Patient characteristics and setting	Inclusion criteria: lesions suspicious of melanoma based on dermatoscopic diagnostic criteria or lesion change; included only a random sample of 50% of benign naevi observed during time period Setting: secondary (general dermatology); Department of Dermatology, University of Modena, Italy Prior testing: clinical and/or dermatoscopic suspicion/changes on digital monitoring Setting for prior testing: secondary (general dermatology) Exclusion criteria: location/site of lesion lesions on soles/palms excluded; lentigo maligna excluded; lesions used in previous assessments or RCM model development Sample size (participants): number included: 195 Sample size (lesions): number included: 195 Participant characteristics: median age: 42 (7‐88 years); IQR 32y, 59y; male: 51.3% Lesion characteristics: pigmented: 92%; 8% amelanotic lesions or those with tan, light grey, or pale blue pigment only). Median thickness 0.65 mm (IQR 0.23mm, 0.98mm)
Index tests	Dermoscopy: pattern analysis Method of diagnosis: in‐person diagnosis; at time of first consultation and prior to RCM Prior test data: clinical examination Diagnostic threshold: NR Diagnosis based on: single observer (n = 1) Observer qualifications: dermatologist; not clearly reported, but is study co‐author Experience in practice: high experience Experience with dermoscopy: high experience; described as Modena expert based in Dermatology Dept Other detail: hand‐held dermoscope (Delta 10, Heine, Herrsching, Germany).
Target condition and reference standard(s)	Reference standard: histological diagnosis alone (not further described) Disease‐positive: 79; disease‐negative: 116 Target condition (final diagnoses) Melanoma (invasive): 61; melanoma (in situ): 18 Benign naevus: 116 (78 compound, 0 dermal, 16 junctional, and 22 Spitz)
Flow and timing	Excluded participants: only 50% of imaged naevi were included (randomly selected from the image database prior to analysis) to reduce the MM/naevus ratio Time interval to reference test: consecutive; imaged prior to biopsy
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?	No
Are the included patients and chosen study setting appropriate?	No
Did the study avoid including participants with multiple lesions?	Yes
		High	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?	No
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?	No
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?	No
		High