Rosendahl 2011.

Study characteristics
Patient sampling	Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: 30‐month period; dates NR Country: Australia
Patient characteristics and setting	Inclusion criteria: consecutive series of pigmented lesions submitted for histology from the primary care skin cancer practice of 1 study author Setting: primary/private; skin cancer practice of 1 study author Prior testing: selected for excision (no further detail) Setting for prior testing: primary Exclusion criteria: poor image quality (considered under Flow and Timing) Sample size (participants): number included: 389 Sample size (lesions): number eligible: 466 pigmented lesions out of 1959 lesions excised or biopsied; number included: 463 Participant characteristics: mean age: 57 years (SD 17); male: 67.4% Lesion characteristics: (53.1%) melanocytic. Lesion site: 17.7% head or face; trunk: 52.1%; 27.6% extremities; 2.2% palms or soles. Melanoma thickness: ≤ 1 mm: 1/29 melanoma (3.4%)
Index tests	VI: no algorithm Method of diagnosis: clinical photographs; overview and close‐up image presented Prior test data: no further information used Other test data: dermoscopic images presented to observer subsequent to diagnosis using clinical images alone Diagnostic threshold: clinical diagnosis/subjective impression. Observers gave a diagnosis with level of confidence (from 0 for definitely benign to 100 for definitely malignant) after viewing the clinical images. (NB used study authors' threshold for detection of any skin cancer, which includes lesions clinically considered to be MM, BCC pigmented epithelial carcinoma including SCC, keratoacanthoma, AK and BD as test‐positive; review only considered histologically confirmed MM, BCC or invasive SCC to be disease‐positive) Diagnosis based on: single observer (n = NR) Observer qualifications: expert dermatologist (based on author communication). Experience in practice: expert Experience with dermoscopy: expert Dermoscopy: pattern analysis; new algorithm; Chaos and clues Method of diagnosis: clinical photographs (one overview and one close‐up), followed by one dermoscopic image presented to a blinded observer on a computer screen Prior test data: clinical image only; diagnosis made based on clinical image before presentation of dermoscopic image Diagnostic threshold: observers gave a diagnosis with level of confidence (from 0 for definitely benign to 100 for definitely malignant). Chaos and clues short algorithm; each assessed for evidence of ‘‘chaos’’ (asymmetry of colour or structure); if present then ‘‘clues’’ searched for. Chaos: asymmetry of structure and colour defined according to the basic principles of pattern analysis as revised by Kittler 2007. Clues included: eccentric structureless zone (any colour except skin colour), grey or blue structures, peripheral black dots or clods, segmental radial lines or pseudopods, polymorphous vessels, white lines, thick reticular or branched lines, and parallel lines on ridges (acral lesions). Observers as for VI
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Details: excise or biopsy Disease‐positive: 138; disease‐negative: 325 Target condition (final diagnoses) Melanoma (invasive): 9; melanoma (in situ): 20; BCC: 72; cSCC: 5 (including 2 keratoacanthoma) 'Benign' diagnoses: 18 BD and 14 AK, 217 benign melanocytic + additional 140 benign non‐melanocytic Note: study authors considered BD, AK and keratoacanthoma as malignant; all considered benign for review analysis
Flow and timing	Excluded participants: lesions were excluded due to poor image quality (n = 3) Time interval to reference test: unclear; lesions 'routinely photographed' if scheduled for excision or biopsy but not further described
Comparative	Blinding between tests: clinical photographs (one overview and one close‐up), followed by one dermoscopic image presented to a blinded observer on a computer screen Time interval between index test(s): consecutive
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 Visual inspection ‐ 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?
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?	No
Was the test interpretation carried out by an experienced examiner?	Yes
		Low	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?	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?	Yes
		Low	Unclear
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?	No
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
DOMAIN 5: Comparative
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies?	No
Was the interval between application of the index tests less than one month?	Yes
Were all tests applied and interpreted in a clinically applicable manner?	No
		Low	High