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

Piccolo 2014.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: September 2010‐October 2013
Country: Italy
Patient characteristics and setting Inclusion criteria: dermoscopically atypical PSLs selected from the archives of the Dermatology Department at the University of L’Aquila, Italy; described as "a panel of ... retrospectively selected PSLs"
Setting: secondary (general dermatology)
Prior testing: NR
Setting for prior testing: NR
Exclusion criteria: location/site of lesion ‐ acral sites and the face
Sample size (participants): number included: 165
Sample size (lesions): number included: 165
Participant characteristics: mean age 43.5 years (range 12‐84 years); male: 59.4%
Lesion characteristics: lesion site; upper extremities 18 (11%); lower extremities 53 (31%); 62 (37.5%) on the back; 32 (19.4%) on the chest. Melanoma thickness 87.9% (29/33) < 0.75 mm; 11% (4/33) > 1.5 mm
Index tests Dermoscopy: ABCD
Method of diagnosis: dermoscopic images
Prior test data: no further information used
Diagnostic threshold: total dermoscopic score > 4.75 and > 5.45
Diagnosis based on: single observer (n = 4)
Observer qualifications: 3 dermatologists and 1 GP with different degrees of dermoscopic experience
Experience in practice: mixed
Experience with dermoscopy: high (observer 1 ‐ dermatologist); moderate (observers 2 and 3 ‐ dermatologists); low (observer 4 ‐ GP; underwent dermoscopic training by studying an interactive atlas of dermoscopy between time periods T0 and T1)
Any other detail: experience was scored based on number of years specialising in dermoscopy; number of PSLs assessed by dermoscopy on a daily basis; number of relevant workshops/seminars attended; and the number of authored publications on dermoscopy.
Target condition and reference standard(s) Reference standard: histological diagnosis alone (not further described)
Target condition (final diagnoses)
Melanoma (invasive): 23; melanoma (in situ): 10
Benign naevus: 105 Clark naevi; 19 Spitz/Reed naevi; 5 blue naevi; 3 dermal naevi
Flow and timing Excluded participants: none reported
Time interval to reference test: 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? 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? Yes    
    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? 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? 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