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

Unlu 2014.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: January 2008‐January 2010
Country: Turkey
Patient characteristics and setting Inclusion criteria: melanocytic lesions excised at Ankara University Department of Dermatology Pigmented Lesion Clinic
Setting: specialist unit; Ankara University Department of Dermatology Pigmented Lesion Clinic
Prior testing: selected for excision (no further detail)
Setting for prior testing: specialist unit (skin cancer/PLC)
Exclusion criteria: location/site of lesion facial, nail and volar acral lesions were excluded; non‐melanocytic appearance
Sample size (participants): number included: 115
Sample size (lesions): number included: 115
Participant characteristics: mean age: 38.72 years (+/‐ 18.46 years). Male: 56 (49%)
Lesion characteristics: lesion site: 100% trunk and limbs. Melanoma thickness: 10 (41.7%) < 0.75 mm; 14 (58.3%) ≥ 0.75 mm
Index tests VI: no algorithm; appears to be original clinical diagnosis at time of lesion presentation
Method of diagnosis: in‐person diagnosis. Appears to be diagnosis on presentation
Prior test data: N/A; in‐person diagnosis
Other test data: dermoscopic images presented to different observers
Diagnostic threshold: NR
Diagnosis based on: unclear; for VI appears to be single examiner at time of clinic diagnosis (n = NR); dermoscopic images "scored by three other experienced dermatoscopists"
Observer qualifications: NR; assumed dermatologists; described as experienced dermatoscopists
Experience in practice: unclear for clinic diagnosis; dermatoscopists described as "experienced"
Experience with index test: described as "experienced"
Dermoscopy 3‐point rule; 7PCL; ABCD; CASH algorithm
Method of diagnosis: dermoscopic images
Prior test data: no further information used; clinical image evaluation appears to be separate from dermoscopy interpretation
Diagnostic threshold: ABCD score ≥ 5.45 highly suggestive for melanoma; 7‐point score ≥ 3; 3‐point score 2 or 3 criteria present; CASH algorithm ≥ 8
Observers: as described for Visual Inspection above
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Disease‐positive: 24; disease‐negative: 91
Target condition (final diagnoses) 
 Melanoma (in situ and invasive, or NR): 24
'Benign' diagnoses: 91 melanocytic benign lesions; 37 (32.2%) dermal naevi; 15 (13%) Clark's naevi; 14 (12.2%) compound naevi; 13 (11.3%) blue naevi; 6 (5.2%) SN; 4 (3.5%) congenital melanocytic naevi; 2 (1.7%) junctional naevi
Flow and timing Excluded participants: none reported
Time interval to reference test: NR
Comparative Blinding between tests: used in‐person clinical diagnosis; clinical image evaluation appears to be separate from dermoscopy interpretation
Time interval between index test(s): appear to be consecutively applied but not described
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? Yes    
    Low 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? Unclear    
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    
    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? 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  
DOMAIN 5: Comparative
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies? Yes    
Was the interval between application of the index tests less than one month? Unclear    
Were all tests applied and interpreted in a clinically applicable manner? No    
    Unclear High