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. 2018 Dec 4;2018(12):CD011902. doi: 10.1002/14651858.CD011902.pub2

Ferris 2015.

Study characteristics
Patient sampling Study design: unclear. Some dermoscopic images were collected prospectively and some were obtained from collection of existing images; selection process not described
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR
Country: USA
Test set derived: study developed a new CAD classifier using training/test set of images; plus a 'reader study'* conducted to compare accuracy with dermatologist interpretation of images (*reported here). Some dermoscopic images used to train the classifier were obtained from publicly available or purchased image libraries, these were not included in the reader study or used to test the performance of the classifier. The image set was randomly divided into 2 by diagnosis, with half used for training and half used for testing, with the exception that all high‐grade dysplastic naevi were exclusively assigned to the training set to increase the representation of dermoscopic features that could be present in melanoma. Results were extracted only for the test set.
Patient characteristics and setting Inclusion criteria: dermoscopic images of skin lesions excised on the basis of clinical suspicion of malignancy, with available histologic diagnoses. Reader study included one melanoma that was misclassified as benign by the new CAD classifier + random sample of images determined to be of suitable quality for display on a computer screen.
Setting: secondary (general dermatology)
Prior testing: clinical suspicion (no further detail)
Setting for prior testing: secondary (general dermatology)
Exclusion criteria: high‐grade dysplastic naevi were not included in the test set or reader study
Sample size (participants): number eligible: NR; number included: NR
Sample size (lesions): number eligible: 473 (includes 273 randomised to training set and 27 non‐biopsied lesions); number included: CAD test set 173 lesions; dermoscopy‐ 65 lesions
Participant characteristics: none reported
Lesion characteristics: test set: mean lesion thickness 0.76 mm, median 0.5 mm, range 0.2‐98 mm); reader study: mean 0.93 mm, median 0.74 mm, range 0.2‐98 mm.
Index tests Dermoscopy: no algorithm
Method of diagnosis: dermoscopic images
Prior test data: no further information used
Diagnostic threshold: NR
Diagnosis based on: average (n = 30); 35 invited to participate.
Observer qualifications: 2 board‐certified dermatologists, 10 dermatology residents, and 8 physician assistants currently practicing dermatology
Experience in practice: mixed
Experience with dermoscopy: mixed; all observers self‐reported some training and experience with the use of dermoscopy. Among board‐certified dermatologists, 67% reported using dermoscopy ‘‘always/almost always’’ or ‘‘very frequently.’', compared to 90% of the dermatology residents and 75% of the physician assistants.
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Details: all lesions were biopsied based on clinical suspicion of malignancy. All histologic diagnoses were rendered by at least 1 board‐certified dermatopathologist and were used as the reference standard for diagnosis
 Disease‐positive: dermoscopy 25 MM; CAD 39 MM/disease‐negative: dermoscopy 40 MM; CAD 134 MM
Target condition (final diagnoses)
For reader study only:
Invasive melanomas 15; melanoma in situ 10
Low‐grade dysplastic naevi 16, benign naevi 14 , blue naevi 2, lentigines 4 , SK 4
Flow and timing Excluded participants: none reported
Time interval to reference test: "Dermoscopic images of skin lesions were collected before biopsy"
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? Unclear    
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? Unclear    
    Unclear 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? Unclear    
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? Unclear    
    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    
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