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

Zaumseil 1983.

Study characteristics
Patient sampling Study design: CS
Data collection: NR
Period of data collection: 1976‐1981
Country: Germany
Patient characteristics and setting Inclusion criteria: skin lesions undergoing excision
Setting: secondary (not further specified)
Prior testing: selected for excision (no further detail)
Setting for prior testing: specialist unit (skin cancer clinic/PLC) Described as 'skin clinic'
Exclusion criteria: disagreement between evaluators on tumour histological classification. Those in which the histological diagnosis was 'unclear' were excluded, melanoma metastases were excluded
Sample size (participants): NR
Sample size (lesions): number included: 7063
Participant characteristics: none reported
Lesion characteristics: none reported
Index tests VI: no algorithm
Method of diagnosis: in‐person diagnosis
Prior test data: N/A, in‐person diagnosis
Diagnostic threshold: primary diagnosis of melanoma (method of Kopf 1975 was cited)
Diagnosis based on: single observer (n = NR)
Observer qualifications: NR
Experience in practice: not described
Experience with index test: not described
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Disease positive: 337; disease negative: 6726
Target condition (final diagnoses)
Melanoma (invasive or in situ): 337
 Other diagnoses only listed for the 89 false‐positives: 23 benign naevi; 13 BCC; 12 blue nevus; 11 angiomatosis; 10 SK; 6 histiocytoma; 4 Spitz nevus; 4 lentigo; 3 Bowen's disease; 1 acrospiroma; 1 keratinizing papilloma
Flow and timing Excluded participants: none reported
Time interval to reference test: 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? 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 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? 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? 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    
    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  

ABCD(E): asymmetry, border, colour, differential structures (enlargement); AK: actinic keratosis; AMN: atypical MN; BCC: basal cell carcinoma; CAD: computer‐assisted diagnosis; CCS: case‐controlled study; CD: compact disc; CM: cutaneous melanoma; CMM: cutaneous malignant melanoma; CS: case series; cSCC: cutaneous squamous cell carcinoma; DF: dermatofibroma; ELM: epiluminescence microscopy; FN: false‐negative; FP: false‐positive; GP: general practitioner; H&E: haematoxylin and eosin stain; LPLK: lichen planus‐like keratosis; LS: lentigo simplex; MM: malignant (invasive) melanoma; MN: melanocytic naevi; MSDSLA: multispectral digital skin lesion analysis device; N/A: not applicable; NMLs: non‐melanocytic lesions; NR: not reported; PCPs: primary care providers; PLC: pigmented lesion clinic; PSL: pigmented skin lesion; RCM: reflectance confocal microscopy; RCT: randomised controlled trial; SCC: squamous cell carcinoma; SD: standard deviation; SDDI: short‐term sequential digital dermoscopy imaging; SK: seborrhoeic keratosis; SSM: superficial spreading melanoma; SVS: support vector system; VI: visual inspection; 7FFM: seven features for melanoma