Glud 2009.

Study characteristics
Patient sampling	Study design: case series Data collection: prospective; dermoscopic images assessed remotely from the patient Period of data collection: January‐April 2007 Country: Denmark
Patient characteristics and setting	Inclusion criteria: patients referred for excision biopsy of pigmented lesions where the diagnosis of melanoma could not be excluded on clinical investigation Setting: secondary (other); Dept Plastic Surgery and Burn Unit Prior testing: clinical suspicion of malignancy Setting for prior testing: secondary (not further specified) Exclusion criteria: none reported Sample size (participants): number included: 65 Sample size (lesions): number included: 83 Participant characteristics: median age 47 years (18‐90 years); male = 29; 45% Lesion characteristics: melanoma thickness 0.29 mm‐18 mm
Index tests	Dermoscopy: no algorithm Method of diagnosis: dermoscopic images Prior test data: no further information used Diagnostic threshold: NR; diagnosis of melanoma Diagnosis based on: single observer (n = 1) Observer qualifications: dermatologist Experience in practice: high Experience with dermoscopy: high experience; "dermoscopic images were examined by an experienced dermatologist" Any other detail: the dermoscopic and SIAgraphic images were obtained by SIAscope II (Amon Clinica, Cambridge, UK) and stored using the proprietary Dermetrics software (Astron Clinica).
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Details: following image acquisition "the excision biopsy was performed and an experienced histopathologist examined the tissue". Breslow thickness and Clark level were determined by standard: histopathologic examination. Tumour staging was performed as described by Balch et al according to the 2001 melanoma staging system (Balch 2001). Disease‐positive: 12; disease‐negative: 71 Target condition (final diagnoses) Melanoma (invasive): 7; melanoma (in situ): 5; 1 melanoma metastasis (included as benign) Sebhorrheic keratosis: 1; benign naevus: 57; 'Benign' diagnoses: BD 1, haemangioma 1, LS 2, epidermal naevi 2, DF 6
Flow and timing	Participant exclusions: none reported Index test to reference standard interval: following image acquisition "the excision biopsy was performed"
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?	No
		Low	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?	Yes
		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