Sboner 2004.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: Italy (based on authors' institution) |
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Patient characteristics and setting |
Inclusion criteria: melanocytic lesion images acquired consecutively by d‐ELM at the Department of Dermatology of Santa Chiara Hospital, Trento Setting: secondary (general dermatology) Prior testing: selected for excision (no further detail) Setting for prior testing: NR Exclusion criteria: seems that dysplastic naevi were excluded; "In this experimental setting, there were no dysplastic naevi" Sample size (participants): NR Sample size (lesions): number included: 152 Participant characteristics: none reported Lesion characteristics: mean Breslow thickness for the invasive lesions is 1.0 +/‐ 0.7 mm; 81% ≤ 1.5 mm |
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Index tests |
Dermoscopy: no algorithm Method of diagnosis: dermoscopic images; digitial‐ELM images presented on video device Prior test data: no further information used Diagnostic threshold: NR; appears to be correct diagnosis of melanoma Diagnosis based on: single observer and average (n = 8) Observer qualifications: dermatologist Experience in practice: not described Experience with dermoscopy: not described Any other detail: the d‐ELM Image Acquisition consists of a Leica WILD M‐650 stereomicroscope (Leica Microsystem, Heerbrugg, Switzerland), with a SONY 3CCD DXC‐930P colour camera (Sony Corporation,Tokyo, Japan). The software for image acquisition was DBDERMO MIPS (Dell’Eva/Burroni Studio, Florence/Siena, Italy). The digital image size has a spatial resolution of 768 x 576 pixels and a 24‐bit colour resolution |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Disease‐positive: 42; disease‐negative: 110 Target condition (final diagnoses) Melanoma (invasive): 31; melanoma (in situ): 11 Benign naevus: 110 |
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Flow and timing |
Participant exclusions: none reported Index test to reference standard interval: not described |
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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? | 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? | Unclear | ||
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? | Unclear | ||
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? | No | ||
Was the test interpretation carried out by an experienced examiner? | Unclear | ||
Unclear | 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 |