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

Skvara 2005.

Study characteristics
Patient sampling Study design: case‐control
Data collection: retrospective image selection/prospective interpretation
Period of data collection: July 1996‐September 1996
Country: Austria
Patient characteristics and setting Inclusion criteria: consecutive lesions excised due to changes over time during digital dermoscopy follow‐up (appear to be from patients with multiple melanocytic naevi); all lesions were assessed for presence of dermoscopic characteristics and all melanomas + random sample of same number of benign were assessed by dermoscopic algorithms (included in review)
Setting: secondary (general dermatology)
Prior testing: NR
Setting for prior testing: unspecified
Exclusion criteria: location/site of lesion ‐ palmar, plantar, facial lesions; lesion size lesions that exceeded maximum field of view of the electronic camera
Sample size (participants): NR
Sample size (lesions): number included: 126
Participant characteristics: none reported
Lesion characteristics none reported
Index tests Dermoscopy 7PCL and ABCD
Method of diagnosis: dermoscopic images presented on a computer screen
Prior test data: no further information used
Diagnostic threshold: ABCD score > 4.75; 7PCL score > 2
Diagnosis based on: single observer (n = 2)
Observer qualifications: dermatologist
Experience in practice: assumed high; paper describes assessment of baseline images for dermoscopic criteria by "2 experienced dermatologists"; "additionally, the baseline images of (a subgroup of lesions) were evaluated by 2 blinded investigators). These appear to be separate groups of observers but have assumed similar levels of experience.
Experience with dermoscopy: assumed high (as above)
Target condition and reference standard(s) Reference standard: histological diagnosis alone (but all lesions followed up)
Details: "standard: histopathology" following lesion changes over time
Disease‐positive: 63; disease‐negative: 63
Target condition (final diagnoses)
Melanoma (in situ and invasive, or NR): 63
Benign naevus: 63
Flow and timing Participant exclusions: none reported
Index test to reference standard interval: lesions suggestive of melanoma at baseline were removed at the patient’s initial visit (immediately); the others were followed up for 3‐6 months until lesion changes initiated excision
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? Yes    
Was a case‐control design avoided? No    
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? Unclear    
    High 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? No    
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 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? Unclear    
    Low Unclear
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? 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? Yes    
    Low