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 |
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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). |
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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. |
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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 |
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Flow and timing |
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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 |