Haenssle 2010b (FU).

Study characteristics
Patient sampling	Study design: case series Data collection: prospective Period of data collection: 1998‐2008 Country: Germany
Patient characteristics and setting	Inclusion criteria: participants at increased risk for melanoma: > 50 common and/or ≤ 3 atypical naevi; atypical mole syndrome; or familial atypical mole and multiple melanoma syndrome Setting: secondary (dermatology) Prior testing: all identified as high risk Setting for prior testing: NR Exclusion criteria: patients showing melanoma development on pre‐existing pigmented lesions during the following 12 months after the analysed time frame Sample size (participants): 688 Sample size (lesions): 11,137 Participant characteristics: mean age 42 (range NR). 60% male. Mean age 42 (range NR). 60% male. Group 1 (50 common and/or ≤ atypical naevi) 67%; Group 2 (atypical mole syndrome) 31.8%; Group 3 (familial atypical mole and multiple melanoma syndrome) 1.2%. Personal history of melanoma (29.2%); family history of melanoma (13.1%); high number (> 50) of naevi (56.4%) Lesion characteristics: NR
Index tests	Dermoscopy: 7PCL Method of diagnosis: in person Prior test data: also considered lesional history (e.g. increase in size, itching, scaling, change in colour, intermittent bleeding), and the ugly duckling sign (Grob 1998) and 'moles‐breed‐true' concept (Scope 2006). Lesions scoring < 3 on 7PCL were excised if these other factors were present at first visit. Lesions scoring < 3 with defined clinical or dermatoscopic criteria of atypia (e.g. asymmetry in shape, irregular margin, variegated colour, prominent pigment network) (Ascierto 2000) were marked on digital overview images and electronically stored by using 2 digital dermatoscopy systems for follow‐up Diagnostic threshold: ≥ 3 Diagnosis based on: consensus of 2 Observer qualifications: dermatology residents (n = 13); supervised by experienced dermatologist Experience in practice: NR Experience with dermoscopy: high; formally trained in dermoscopy
Target condition and reference standard(s)	Reference standard: histology or follow‐up (every 3, 6, or 12 months); mean follow‐up 44.28 (range 2‐123) months Target condition (final diagnoses) Invasive melanoma 77; melanoma in situ 50; BCC 2 Benign naevi 1047; SN 16; SK 12; other benign 9935 (not excised)
Flow and timing	Excluded participants: none reported Time interval to reference test: consecutive
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?	No
		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?	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?	No
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
		High	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?	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