Menzies 2008.

Study characteristics
Patient sampling	Study design: case series? Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: multicentre
Patient characteristics and setting	Inclusion criteria: dermoscopic amelanotic (with no melanin pigmentation) or hypomelanotic (a melanin pigmentation area of < 25% of the total surface area or slightly pigmented but with no dark brown, deep blue, or black pigmentation) lesions. All melanomas included, and a random selection of melanocytic and non‐melanocytic lesions on a non‐melanoma to melanoma ratio of 3:1 Setting: multicentre Prior testing: NR Setting for prior testing: NR Exclusion criteria: lesions were excluded because of poor image quality or because they did not fit within any of the defined pigmentation categories Sample size (participants): NR Sample size (lesions): 497 Participant characteristics: NR Lesion characteristics: NR
Index tests	Dermoscopy: 7PCL; Menzies; 3PCL (new algorithm for distinguishing melanoma from non‐melanoma and any malignant from benign lesions was also developed on 80% of sample and tested on 20% but numbers disease‐positive and ‐negative for the test set were NR to allow 2x2 to be estimated.) Method of diagnosis: image‐based Prior test data: NR Diagnostic threshold: ≥ 3; Menzies standard threshold; ≥ 2 Diagnosis based on: single observer Observer qualifications: dermatologist (assumed) (n = 12); clinicians experienced in dermoscopic evaluation scored 99 individual morphological features in approximately equal sample sizes Experience in practice: NR Experience with dermoscopy: high
Target condition and reference standard(s)	Reference standard: histology and follow‐up (numbers NR; some naevi included that showed no changes following consecutive digital monitoring) Target condition (final diagnoses) Invasive melanoma 91; melanoma in situ 14; BCC 126; cSCC 4 Benign naevi 159; SN 11; SK 22; DF 17; BD 7; keratoacanthoma 1; AK 8; other 37
Flow and timing	Excluded participants: none reported Time interval to reference test: NR
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?	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?	Yes
For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others?	No
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?	Unclear
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
		Unclear	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?	No
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?
		High