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. 2018 Dec 4;2018(12):CD013194. doi: 10.1002/14651858.CD013194

Krahn 1998.

Study characteristics
Patient sampling Study design: CS
Data collection: prospective
Period of data collection: NR
Country: Germany
Patient characteristics and setting Inclusion criteria: excised PSLs
Setting: secondary (general dermatology)
Prior testing: NR
Setting for prior testing: NR
Exclusion criteria: none reported
Sample size (participants): number included: 80
Sample size (lesions): number included: 80
Participant characteristics: none reported
Lesion characteristics range in thickness (melanomas) 0.18‐1.9 mm; 29/39 < 0.76 mm; 7/39 0.76‐1.5 mm; 3/39 > 1.5 mm
Index tests VI: no algorithm reported
Method of diagnosis: in‐person diagnosis
Prior test data: unclear
Other test data: dermoscopy undertaken by same clinician(s) subsequent to clinical evaluation
Diagnostic threshold: NR; no details
Diagnosis based on: single observer (n = 1)
Observer qualifications: NR, likely dermatologist
Experience in practice: not described
Experience with index test: not described
Dermoscopy: evaluated in same study; no algorithm
Target condition and reference standard(s) Reference standard: histological diagnosis alone including histometrics
Disease positive: 39; disease negative: 41
Target condition (final diagnoses)
Melanoma (invasive): 39 (SSM, lentigo MM, nodular M)
Benign naevus: 37 common naevus; 3 dysplastic nevus, 1 Spitz naevus
Flow and timing Excluded participants: none reported
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? Unclear    
Are the included patients and chosen study setting appropriate? No    
Did the study avoid including participants with multiple lesions? Yes    
    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 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? Unclear    
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?      
    Unclear