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

Stolz 1994a.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: from 1989‐1991
Country: Germany
Test set derived: 157 cases were randomly divided into a test and training set.
Patient characteristics and setting Inclusion criteria: equivocal melanocytic skin lesions < 9 x13 mm, melanoma tumour thickness of ≤ 1 mm and melanoma Clark's ≤ level III
Setting: secondary (general dermatology); Univerisity of Munich Department of Dermatology
Prior testing: selected for excision (no further detail)
Setting for prior testing: NR
Exclusion criteria: none reported
Sample size (participants): NR
Sample size (lesions): number eligible: 650 cases/number included: 157 lesions
Participant characteristics: none reported
Lesion characteristics: melanoma thickness: 50 ≤ 0.4 mm; 30 ≤ 0.75 mm; 15 ≤ 1 mm
Index tests Dermoscopy: ABCD
Method of diagnosis: dermoscopic images; colour prints examined for 31 dermoscopic features, most listed in the guidelines of the Consensus Conference of Surface Microscopy held in Hamburg in 1989 (Bahmer 1990); described as a "blind study"
Prior test data: no further information used
Diagnostic threshold: > 5.45; multivariate analysis of training set data identified 8 features with the lowest P values; the total dermoscopic score (TDS) was then developed based on: asymmetry score x 1.3 + Border score x 0.1 + Colour score x 0.5 + Differential structure score x 0.5. New formula then evaluated on the test set of images.
Diagnosis based on: single observer (n = 1)
Observer qualifications: NR; co‐author, assumed to be dermatologist
Experience in practice: not described
Experience with dermoscopy: not described
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Details: histology undertaken by 2 independent histopathologists
Disease‐positive: test set = 48; disease‐negative: test set = 31
Target condition (final diagnoses)
Melanoma (invasive): 85; melanoma (in situ): 10
'Benign' diagnoses: 62 melanocytic naevi; 17 junctional; 40 compound; 5 dermal
Flow and timing Participant exclusions: none reported
Index test to reference standard interval: not described
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? Yes    
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?      
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? 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