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

Nachbar 1994.

Study characteristics
Patient sampling Study design: case series
Data collection: prospective
Period of data collection: November 1991‐July 1992
Country: NR (authors' institutions Germany and USA)
Patient characteristics and setting Inclusion criteria: pigmented melanocytic skin lesions consecutively excised
Setting: secondary (general dermatology)
Prior testing: selected for excision (no further detail)
Setting for prior testing: NR
Exclusion criteria: unequivocal appearance/diagnosis criteria used to exclude non‐melanocytic described in detail in Table 1
Sample size (participants): NR
Sample size (lesions): number included: 194
Participant characteristics: none reported
Lesion characteristics: thickness, 35/69 MM ≤ 0.75 mm (50.7%)
Index tests Dermoscopy: ABCD
Method of diagnosis: in‐person diagnosis
Prior test data: clinical examination and/or case notes
Diagnostic threshold: > 5.45 (determined based on retrospective analysis of the data)
For the calculation of ABCD score the criteria of asymmetry (A), abrupt cutoff of the pigment pattern at the border (B), different colours (C), and different structural components (D) were assessed to yield a semiquantitative score (all described in detail). "The results of the retrospective study showed that melanocytic pigmented skin lesions could be differentiated into two diagnostic groups as follows: melanocytic naevi (MN) if the final score was less than 5.45 and MM if the score was higher than 5.45. Retrospective analysis showed an early melanoma could not be completely excluded in all lesions with an ABCD score between 4.75 and 5.45.Therefore these lesions were excised. All lesions were examined by two independent dermatopathologists."
Diagnosis based on: unclear (n = NR)
Observer qualifications: NR; presumably dermatologists; "colleagues in our department"
Experience in practice: high experience or ‘Expert’
Experience with dermoscopy: high experience /‘Expert’ users
Study also presents 2x2 data for VI; excluded from review as clinicians 'mostly' also used dermoscope for diagnosis. From text: "In comparing the clinical with the dermatoscopic diagnosis with the ABCD rule it must be noted that all our colleagues in this department referring patients for the study were experienced and in most cases used the dermatoscope without applying the new ABCD rule. Thus clinical diagnosis in our study was expected to be already biased by the dermatoscopic feature and therefore to be more accurate than by the naked eye"
Target condition and reference standard(s) Reference standard: histological diagnosis alone 194 (not further described) 
 Disease‐positive: 69; disease‐negative: 125
Target condition (final diagnoses)
Melanoma (in situ and invasive, or NR): 69
 BCC: 3
Sebhorrheic keratosis: 19
 'Benign' diagnoses: 103 melanocytic naevus
Flow and timing Time interval to reference test: NR
Time interval between index test(s): appears consecutive
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? Yes    
Are the included patients and chosen study setting appropriate? No    
Did the study avoid including participants with multiple lesions? Unclear    
    Low High
DOMAIN 2: Index Test Dermoscopy ‐ 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? No    
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? Yes    
    High 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