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

Dummer 1993.

Study characteristics
Patient sampling Study design: case series
Data collection: prospective; dermoscopic images assessed remotely from the patient
Period of data collection: 12 month period (year/dates NR)
Country: Germany
Patient characteristics and setting Inclusion criteria: patients with skin lesions difficult to diagnose clinically
Setting: secondary
Prior testing: clinical suspicion of malignancy without dermatoscopic suspicion
Setting for prior testing: specialist unit (skin cancer/PLC) a type of specialist care‐ dermatology based clinic
Exclusion criteria: patients who had excisions performed in individual practices or where there was no histology or cases that were so obvious they didn't need to have further investigation (clearly benign)
Sample size (participants): NR
Sample size (lesions): number eligible: 824; number included: 771
Participant characteristics: none reported
Lesion characteristics: none reported
Index tests VI: no algorithm
Method of diagnosis: in person
Prior test data: in person
Other test data: dermoscopic images viewed separately
Diagnostic threshold: NR
Diagnosis based on: single observer; (n = 2 or 3)
 Observer qualifications: unclear; clinician based in dermatology clinic (assumed dermatologist)
Experience in practice: unclear
Experience with index test: unclear
Dermoscopy: pattern analysis
Method of diagnosis: dermoscopic images
Prior test data: unclear
Diagnostic threshold: NR
Observers: as described above
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Disease‐positive: 23 MM; disease‐negative: 748 benign
Target condition (final diagnoses)
Invasive melanoma: 23
 Benign naevus 706; SK 4; benign non‐melanocytic naevus 32
Flow and timing Excluded participants: 53 non‐melanocytic lesions not included in the final analysis (no melanomas present in this group)
Time interval to reference test: NR
 Time interval between index test(s): 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? Yes    
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 Visual Inspection ‐ in‐person
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? 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? 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? 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? 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? No    
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