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. 2018 Dec 4;2018(12):CD013193. doi: 10.1002/14651858.CD013193

Ferrara 2004.

Study characteristics
Patient sampling Study design: case control
Data collection: retrospective image selection/prospective interpretation
Period of data collection: NR
Country: NR; likely Italy
Patient characteristics and setting Inclusion criteria: pigmented melanocytic lesions with dermoscopic images (a single image per case) and accompanying histological material were retrieved; approach to lesion selection was not described.
Setting: unspecified
Prior testing: clinical or dermatoscopic (or both) suspicion
Setting for prior testing: NR
Exclusion criteria: none reported
Sample size (participants): NR
Sample size (lesions): number included: 12
Participant characteristics: 10 males and 2 females, aged 14–79 (median 41) years.
Lesion characteristics: 7 lesions removed from the trunk, 4 from the limbs and 1 from the face. Lesions ranged in size from 4 mm to 14 mm in diameter (median 6 mm).
Index tests TD
Acquisition and transmission of images: dermoscopic images were either acquired on film (Dermaphot) and then digitised (8) or were acquired directly from a digital camera (4); (MoleMax or Videocap) photographic images were also available in 9/12 cases.
Nature of images used: dermoscopic images
Any additional participant information provided: clinical examination or case notes (or both)
Observer qualifications (remote diagnosis): dermatologist
Diagnosis based on: single observer
Number of examiners: 3
Method of diagnosis: stored images were viewed on a standard‐resolution colour monitor by 3 remote consultants in a single session; the teledermoscopy diagnosis (melanoma or other lesion type) was recorded by a single consultant, followed by a teledermatopathology diagnosis (based on histological image). The original histological diagnosis from the consultation file was then presented (apparently along with the original clinical diagnosis). "Dermoscopic–pathological remarks" were made and finally a consensus diagnosis was reached by 2 consultants; the latter was taken as the 'gold standard' for the study.
Target condition and reference standard(s) Reference standard: histological diagnosis alone
Details: 12 cases with dermoscopic images (1 image per case) and accompanying histological material were retrieved from consultation files. The conventional histopathology diagnosis was regarded as the gold standard: a consensus diagnosis between 2 consultants was requested in order to minimise any influence of the
 previous dermatopathology diagnosis
Target condition (final diagnoses)
Melanoma (in situ and invasive, or NR): 7. Invasive melanoma: 4; MiS: 3
'Benign' diagnoses: 5. Junctional nevus: 1; Reed naevus: 1; blue naevus: 1; actinic lentigo: 1; SN: 1
Flow and timing
  • Excluded participants: NR

  • Time interval to reference test: images taken at time of FTF consultation; interval to excision NR

  • Time interval between index test(s): NR

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? No    
Did the study avoid inappropriate exclusions? Unclear    
Are the included patients and chosen study setting appropriate? Unclear    
Did the study avoid including participants with multiple lesions? Unclear    
    High Unclear
DOMAIN 2: Index Test Teledermatology
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    
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? Unclear    
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    
For studies comparing TD/FTF clinical diagnosis to histology, was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? Yes    
For studies comparing TD to FTF diagnosis, was the clinical diagnosis carried out by an experienced observer?      
    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 FU of borderline/benign appearing lesions, was there a minimum FU following application of index test(s) of at least: 3 months for melanoma or cSCC or 6 months for BCC?      
    Unclear