Stanganelli 2000.

Study characteristics
Patient sampling	Study design: Case series Data collection: Retrospective Period of data collection 1994 ‐ 1996 Country Italy
Patient characteristics and setting	Inclusion criteria: Patients with pigmented skin lesions referred by dermatologists and general practitioners either for pre‐surgical assessment or consultation Setting: Specialist unit (skin cancer/pigmented lesions clinic) Prior testing: Patients referred for pre‐surgical assessment or consultation indicating they have had prior tests Setting for prior testing: Primary: some patients referred for consultation only; dermoscopy findings are reported back and management decision remains with referring clinician; Secondary (general dermatology) Exclusion criteria: NR Sample size (patients): N eligible: 1556 Sample size (lesions): N eligible: 3372; N included: 3372 Participant characteristics: Median age 30 years, range 10 to 94; Male: 522 (34%) Lesion characteristics: NR
Index tests	Visual inspection (VI) ABCD Method of diagnosis: In‐person diagnosis Prior test data: N/A in‐person diagnosis Other test data: Dermoscopic and clinical images subsequently presented separately to observer subsequent to diagnosis using clinical images alone Diagnostic threshold: NR Diagnosis based on: Single observer; N = 1 Observer qualifications: NR; described as 1 of the co‐authors and study based in skin cancer clinic ‐ likely dermatologist Experience in practice: Not described Experience with dermoscopy: Not described Other detail: A crude clinical image (magn x 6 and x 10) was recorded in the digital database Dermoscopy: Pattern analysis Method of diagnosis: Unclear; participants seen in person but dermoscopic diagnosis made based on digital ELM image (by same clinician as in‐person clinical dx) Prior test data: Combined clinical/dermoscopy diagnosis Diagnostic threshold: Diagnosis described as based on an integrated synopsis of the patterns most commonly described in the literature (Steiner 1993) and generally associated with known histologic counterparts. Features were assessed described in detail with multiple references, including: presence of pigment network, sharp margins, abrupt edge of pigment network, branched streaks, pseudopods, radial streaming, brown globules, pigment dots, whitish or whitish‐blue veil, grey‐blue areas, white or depigmented areas, maple leaf areas, milia‐cysts, horny plugs and vascular patterns. Test observers: As described for Visual Inspection (above) Experience with dermoscopy: Any other detail. The equipment consisted of a Leica Wild M‐650 stereomicroscope (Leica AG, Heerbrugg, Switzerland), a Sony 3ccd DXC‐930P colour video camera, an AT‐Vista videographics adapter, and IBM personal computer, a Sony Trinitron Analog PVM‐2043MD monitor, and the DBDERMO MIPS software
Target condition and reference standard(s)	Reference standard: Histological diagnosis plus follow‐up; histology report of known surgical excisions (n = 262) plus a cancer registry‐based follow‐up of benign cases (N = 3110) Target condition (Final diagnoses): Melanoma (in situ and invasive, or not reported): 55; BCC: 43; 'Benign' diagnoses: 3274
Flow and timing	Excluded participants: None reported Time interval to reference test: NR
Comparative	Time interval between index test(s): not clearly reported just indicated that D‐ELM was performed soon after clinical examination
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?	Yes
Did the study avoid including participants with multiple lesions?	No
		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?	Yes
Was the test interpretation carried out by an experienced examiner?	Unclear
		Low	Unclear
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?	Unclear
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication?	Yes
Was the test interpretation carried out by an experienced examiner?	Unclear
		Low	Unclear
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
Were the reference standard results interpreted without knowledge of the referral diagnosis?	Unclear
		High	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?	Yes
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