Rao 1997.

Study characteristics
Patient sampling	Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: USA
Patient characteristics and setting	Inclusion criteria: patients with atypical melanocytic lesions or suspected early malignant melanoma Setting: private care Prior testing: selected for excision (no further detail) Setting for prior testing: private care Exclusion criteria: lesions > 13 mm in diameter were excluded as they could not fit entirely within the standardised photographs Sample size (participants): number included: 63 Sample size (lesions): number included: 72 Participant characteristics: none reported Lesion characteristics: melanoma thickness ≤ 1 mm: 100% of MM (n = 21)
Index tests	VI: ABCD Method of diagnosis: clinical photographs and dermoscopic images Prior test data: dermoscopic images also presented to observer but unclear whether both viewed at the same time or not, "Each color transparency was independently analyzed" by observers. The 1) clinical, 2) 'overall' dermoscopic, and 3) 'ABCD scored' dermoscopic diagnoses of either MM or atypical melanocytic naevi were recorded for each lesion by the same observers. No indication of blinding between images Diagnostic threshold: clinical variables were defined as follows: asymmetry (A): both silhouette and colour distribution were considered. Border irregularity (B): this was judged by the unevenness of the perimeter. Colour (C): colour variegation and number of colours were evaluated. Diameter (D): the largest in situ diameter in mm of each lesion was recorded Diagnosis based on: single observer (n = 4) Observer qualifications: 2 experienced dermatologists, and 2 melanoma fellows Experience in practice: mixed experience (low and high experience combined) Experience with dermoscopy: NR Dermoscopy: ABCD and no algorithm Method of diagnosis: clinical photographs and dermoscopic images Prior test data: clinical examination and/or case notes. The 1) clinical, 2) 'overall' dermoscopic, and 3) 'ABCD scored' dermoscopic diagnoses of either MM or atypical melanocytic naevi were recorded for each lesion by the same observers. No indication of blinding between images Diagnostic threshold: ABCD‐scored dermoscopic diagnosis (lesions with a score of ≤ 4.75 were classified as benign, those with scores 4.76‐5.45 as suspicious, and those with scores > 5.45 as melanomas. Each feature was given a score of ”1”. Thus, the score ranged from 1 to 5.) Overall dermoscopic diagnosis ‐ no threshold reported; the overall dermoscopic impression was recorded based on criteria in the recently published textbook (Stolz 1994b). Test observers: as described for VI (above) Any other detail: all photographs were taken with the Dermophot standard lens‐to‐lesion distance, aperture, and flash. Fujichrome 50 colour 35 mm‐transparency film was used and all exposed film was processed in the same laboratory (Colorite, New York, NY, USA)
Target condition and reference standard(s)	Reference standard: histological diagnosis alone Details: each of the 72 melanocytic neoplasms was histopathologically diagnosed as with atypical melanocytic naevi or an early MM by a dermapathologist with special expertise in melanocytic neoplasms. Each lesion was completed excised and step sectioned. Disease‐positive: 21 MMs; disease‐negative: 51 atypical melanocytic naevi Target condition (final diagnoses) MM (invasive): 21 51 atypical melanocytic naevus
Flow and timing	Excluded participants: none reported Time interval to reference test: NR
Comparative	Blinding between tests: unclear whether both images were viewed at the same time or not Time interval between index test(s): Image‐based; images likely acquired consecutively
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
		Unclear	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?	Unclear
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?	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?	Yes
		Low	Low
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?	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?
		Low
DOMAIN 5: Comparative
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies?	Unclear
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
		Unclear	High