Piccolo 2002.

Study characteristics
Patient sampling	Study design: Case series Data collection: Retrospective image selection/Prospective interpretation Period of data collection: NR; 6‐month period Country: Italy
Patient characteristics and setting	Inclusion criteria: Pigmented lesions excised because of equivocal dermoscopic findings or at the patient’s request Setting: Secondary (general dermatology); from authors' institution Prior testing: Dermatoscopic suspicion; Patient request for evaluation/excision Setting for prior testing: NR Exclusion criteria: None reported Sample size (participants): N included: 289 Sample size (lesions): N included: 341 Participant characteristics: Mean age 33.6 yrs (range 3 – 83); Male: 127 (43.9%); Fitzpatrick phototype I to II (31.4%); Type III (42.2%); Type IV ‐ V (26.4%) Lesion characteristics: None reported
Index tests	Dermoscopy No algorithm Method of diagnosis: Clinical photographs and dermoscopic images Cases were clinically and dermoscopically evaluated on a high‐resolution colour monitor, in a random sequence Prior test data: Unclear. Not specifically described but appears to be images only Diagnostic threshold: NR Diagnosis based on: Single observer (n = 2) Observer qualifications: Dermatologist; Resident clinician with minimal training in PSLs Experience in practice: High experience or ‘Expert’ 5 years of experience; Low experience or recently qualified minimal training in PSLs (6 months of experience, comprising 8 hours of specialised training on 3 consecutive days and 2 hours a week in the routine of dermoscopy) Experience with index test: Mixed Any other detail: Stereomicroscope with magnifications varying from x6 to x40 Computer‐assisted diagnosis ‐ Dermoscopy‐based Derm‐CAD system: DEM‐MIPS (Digital Epi Microscopy Melanoma Image Processing Software; Biomips SRL, Siena, Italy) (ANN classifier) System details: "DEM‐MIPS is designed to evaluate different colorimetric and geometric parameters of a lesion automatically in real time. All digital images of PSLs were collected in a Truevision Advanced Graphic Array format file with a size of 887 kB for each image." Digital dermoscopic images were framed at x16 magnification before analysis with DEM‐MIPS No derivation aspect (External validation study) Described in prior study "DEM‐MIPS is based on an ANN trained with 100 PSLs (50non‐melanomas and 50 melanomas) and is designed toevaluate different colorimetric and geometric parametersof a lesion automatically in real time." No citation given Lesion characteristics assessed: Evaluates colorimetric and geometric features (NR) Additional predictors included: None reported Method of diagnosis: Dermoscopic images CAD‐based diagnosis Prior/other test data: No further information used CAD output: NR Diagnostic threshold: Threshold not reported
Target condition and reference standard(s)	Reference standard: Histological diagnosis alone Histology (not further described); Disease‐positive: 13; Disease‐negative: 328 Target condition (Final diagnoses) Melanoma (in situ and invasive, or NR): 13 Sebhorrheic keratosis: 3; Benign naevus: 316; Other: 7 dermatofibromas, 2 angiomas
Flow and timing	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?	Unclear
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Unclear
Are the included patients and chosen study setting appropriate?	No
Did the study avoid including participants with multiple lesions?	No
Was an adequate spectrum of cases used to train the algorithm?
		Unclear	High
DOMAIN 2: Index Test Computer‐assisted diagnosis
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
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication?	No
Was the test interpretation carried out by an experienced examiner?
Was the CAD model evaluated in an independent study population?	Yes
Was model overfitting accounted for during model development?
Was the diagnostic threshold to determine presence or absence of disease established in a previously published study?	Unclear
		Low	High
DOMAIN 2: Index Test Dermoscopy
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
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
Was the CAD model evaluated in an independent study population?
Was model overfitting accounted for during model development?
Was the diagnostic threshold to determine presence or absence of disease established in a previously published study?
		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
Was the use of expert opinion (with no histological confirmation) avoided as the reference standard?	Yes
Was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist?	Yes
Were the reference standard results likely to correctly classify the target condition (disease negative)?	Yes
		Unclear	Low
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
		Unclear