Wells 2012.

Study characteristics
Patient sampling	Study design: case‐control Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: USA
Patient characteristics and setting	Inclusion criteria: pigmented lesions (melanomas and benign pigmented lesions) selected from a repository of lesions amassed during an acquisition study conducted by MELA Sciences Inc for the US Food and Drug Administration Setting: company database (MELA Sciences Inc) of lesion images Prior testing: selected for excision (no further detail) Setting for prior testing: NR Exclusion criteria: none reported Sample size (participants): NR Sample size (lesions): number included: 47 Participant characteristics: none reported Lesion characteristics: none reported
Index tests	Dermoscopy: no algorithm Method of diagnosis: dermoscopic images Prior test data: clinical images and detailed clinical history; observers "viewed the images and a detailed case history for each lesion but were unaware of the MelaFind recommendations" Diagnostic threshold: clinical diagnosis of melanoma or not; decision to biopsy the lesion Diagnosis based on: average (n = 39) Observer qualifications: dermatologist Experience in practice: not described Experience with dermoscopy: not described
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Details: "Lesions were biopsied in toto and evaluated by a panel of dermatopathologists who were unaware of the MelaFind recommendations" Disease‐positive: 23/disease‐negative: 24 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 23 'Benign' diagnoses: 24
Flow and timing	Participant exclusions: none reported Index test to reference standard interval: consecutive; "prior to biopsy of the lesion, photographs of the lesion were taken"
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?	Unclear
Was a case‐control design avoided?	No
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
		High	High
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?	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?	No
Was the test interpretation carried out by an experienced examiner?	Unclear
		Unclear	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?	Yes
		Low	Low
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