Bono 2006.

Study characteristics
Patient sampling	Study design: CS Data collection: retrospective Period of data collection: January 2003‐December 2004 Country: Italy
Patient characteristics and setting	Inclusion criteria: consecutive patients with PSLs with a maximum diameter of ≤ 3 mm undergoing excision. The decision for diagnostic excision was based on clinical and/or dermoscopic features suggesting a more or less important suspicion for CM Setting: specialist unit (skin cancer clinic/PLC) Istituto Nazionale Tumori of Milan Prior testing: clinical and/or dermatoscopic suspicion Setting for prior testing: specialist unit (skin cancer clinic/PLC) Exclusion criteria: lesion size > 3 mm Sample size (participants): number eligible: 204/number included: 204 Sample size (lesions): number eligible: 206/number included: 206 Participant characteristics: median age: 40 (6‐74); male: 71 (35%) Lesion characteristics: head/neck: 8 (4%); trunk: 84 (41%); limbs: 114 (55%). Median size: 2 mm (1 mm‐3 mm)
Index tests	VI: no algorithm Method of diagnosis: in‐person diagnosis Prior test data: N/A, in‐person diagnosis Other test data: dermoscopy evaluated in same study by same observer(s) Diagnostic threshold: a diagnosis of suspicious CM is made when the level of suspicion is roughly 50% or more; lesions at a lower index of suspicion were considered not CM Diagnosis based on: single observer; n = 1 Observer qualifications: NR (assumed Oncologist as per Bono 2002a and Bono 2002b); "single clinician examining the pigmented lesion" Experience in practice: not described Experience with dermoscopy: not described Dermoscopy: evaluated in same study; Menzies criteria Any other detail: ABCD criteria have been the basis of training at the unit, but is not implemented in diagnosis; preferred emphasis on colour rather than dimensional character
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Details: the slides were evaluated according to widely accepted criteria for the histopathological diagnosis of the various pigmented lesions. Disease positive: 23; disease negative: 183 Target condition (final diagnoses) Melanoma (invasive): 19 (9.2%); melanoma (in situ): 4 (2.0%) Mild/moderate dysplasia: dysplastic naevus 10 (4.9%); junctional naevus 76 (36.9%); compound naevus 50 (24.3%); dermal naevus 12 (5.8%); blue naevus 11 (5.3%); reed naevus 7 (3.4%); Spitz naevus 3 (1.5%); halo naevus 3 (1.5%); LS 7 (3.4%); other 4 (1.9%)
Flow and timing	Excluded participants: none Time interval to reference test: NR
Comparative	Sibngle observer performed both tests Time interval between index test(s): not reported
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?	Yes
		Low	High
DOMAIN 2: Index Test Visual Inspection ‐ 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?	Unclear
		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?	Unclear
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?
		Unclear