Skip to main content
. 2018 Dec 4;2018(12):CD011902. doi: 10.1002/14651858.CD011902.pub2

Rubegni 2012.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: January2008‐December 2010
Country: Italy
Patient characteristics and setting Inclusion criteria: all palmoplantar PSLs observed and removed because of the presence of clinical and/or dermoscopic suspicious features and in the absence of any clear benignity pattern (parallel furrow pattern, lattice‐like pattern or fibrillar pattern).
Setting: secondary (general dermatology)
Prior testing: clinical and/or dermatoscopic suspicion
Setting for prior testing: secondary (general dermatology)
Exclusion criteria: non‐acral lesions; site of lesion in volar skin of the folds near the toes; lesion size > 26 mm diameter; non‐melanocytic appearance; elevated or ulcerated appearance
Sample size (participants): number included: 107
Sample size (lesions): number included: 107
Participant characteristics: mean age: 49.8 years (women); 44.9 years (men); range 19‐73 years; male: 58.9%; ethnicity white: 100%
Lesion characteristics 78 on soles and 19 on palms; 9 (36%) melanomas ≤ 0.75 mm (incl 4 in situ); 11 (44%) 0.76‐1.5 mm in 11/25 lesions; 5 (20%) ≥ 1.50 mm
Index tests Dermoscopy: pattern analysis; 3‐step algorithm for palmoplantar lesions (Koga 2011)
Method of diagnosis: dermoscopic images
Prior test data: no further information used
Diagnostic threshold: clinical diagnosis (melanoma/no melanoma). For the 3‐step algorithm the conventional options are "removal, follow‐up or no follow‐up"; the latter 2 were combined under the term ‘no melanoma’ for study purposes
Diagnosis based on: single observer (n = 2; one per algorithm)
Observer qualifications: dermatologist
Experience in practice: high
Experience with dermoscopy: high; 2 dermatologists with 20 years’ experience
 in dermoscopy
Any other detail: ELM images achieved with the DB‐Mips System; (magnification x 16)
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Details: "Histopathological diagnosis was based on the criteria of the National Institute of Health Consensus Conference"
 Disease‐positive: 25; disease‐negative: 82
Target condition (final diagnoses) 
 Melanoma (invasive): 21; melanoma (in situ): 4
'Benign' diagnoses: 82
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? 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? Yes    
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