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

Benelli 2001.

Study characteristics
Patient sampling Study design: case series
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR ‐ only dates of training course and agreement study given (April‐May 1999)
Country: Italy
Patient characteristics and setting Inclusion criteria: slides of pigmented skin tumours were selected for evaluation during a training course on dermoscopy. Lesions not located on head, palms or soles histological slide available
Setting: training images; authors' institution. Institute of Dermatologic Sciences, University of Milan
Prior testing: slides of pigmented skin tumours were selected for evaluation during a training course on dermoscopy
Setting for prior testing: unspecified
Exclusion criteria: none reported
Sample size (participants): NR
Sample size (lesions): number included: 49 (paper reports 50 but only 49 accounted for in text)
Participant characteristics: none reported
Lesion characteristics: none reported
Index tests VI: ABCDE
Method of diagnosis: clinical photographs
Prior test data: no further information used
Diagnostic threshold: ABCDE Score ≥ 2; presence of 2 criteria; ABCDE Score ≥ 3; presence of 3 criteria. All criteria described in full
Diagnosis based on: single (n = 1); average (n = 65; attending 1/3 courses in dermoscopy held to inform dermatologists about a new dermatoscopic diagnostic method (7FFM))
Observer qualifications: dermatologists
Experience in practice: expert author; not described for participating dermatologists
Experience with dermoscopy: expert author; prior experience not described for participating dermatologists; all underwent dermoscopy training for study purposes
Dermoscopy: 7FFM
Method of diagnosis: dermoscopic images
Prior test data: no further information used although clinicians had evaluated clinical images for the same 50 lesions earlier the same day
Diagnostic threshold: malignant if 7FFM Score ≥ 2; i.e. presence of 1 major feature or concurrent presence of 2 minor features. All criteria described in full
Test observers: as described for VI (above)
Dermoscopy training: 3 one‐day dermatoscopy courses held to inform dermatologists about authors' own new dermoscopy algorithm (7FFM). Each course lasted 6 hours. Morning session participants executed pre‐test interpretation of clinical images using ABCDE. Then principles of dermatoscopy were presented during the course and as post‐test, participants evaluated 50 dermoscopic slides of same lesions using 7FFM
Length of training 1 day (6 hours)
Post‐training experience: < 6months
Training format: in‐person teaching
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Disease‐positive: 12/49 melanomas (paper reports 50 but only 49 accounted for in text)
Target condition (final diagnoses)
Melanoma (invasive): 10; melanoma (in situ): 2; BCC: 2 pigmented BCC
3 seborrhoeic keratoses, 2 pigmented BCC, 1 blue naevus, 2 angiokeratoma, 5 SN, 5 junctional naevi, 9 compound naevi, 10 naevi undergoing regression
Flow and timing Excluded participants: none reported
Time interval to reference test: unclear
Comparative Blinding between tests: clinical images interpreted in the morning and dermoscopic images in the afternoon
Time interval between index test(s): image capture NR
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? Unclear    
Are the included patients and chosen study setting appropriate? No    
Did the study avoid including participants with multiple lesions? Unclear    
    Unclear High
DOMAIN 2: Index Test Visual inspection ‐ 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 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? 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  
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