Binder 1995.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: Austria |
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Patient characteristics and setting |
Inclusion criteria: PSLs with available dermoscopy images, both with and without oil immersion, and histological confirmation of diagnosis. Setting: secondary (general dermatology) Prior testing: selected for excision (no further detail) Setting for prior testing: NR Exclusion criteria: none reported Sample size (participants): NR Sample size (lesions): number included: 240 Participant characteristics: NR Lesion characteristics: median thickness 0.7 mm, IQR 0.48‐0.76 mm; all < 1 cm diameter |
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Index tests |
Dermoscopy: no algorithm Method of diagnosis: dermoscopic images of lesions with and without oil immersion (results with oil immersion used for primary analysis); images randomly presented to prevent consecutive presentation of slides for the same lesion. Each image was shown for 20 seconds with a 20‐minute break after 240 slides Prior test data: no further information presented Diagnostic threshold: correct diagnosis of melanoma. For each PSL image only one diagnosis was allowed (MM or not MM) Diagnosis based on: average (n = 19); 6 ELM experts and 13 randomly picked dermatologist 'nonexperts' Observer qualifications: dermatologist Experience in practice: high ‐ all certified dermatologists, experienced in clinical diagnosis Experience with dermoscopy: mixed. 'Nonexperts' had no formal ELM training; ‘expert’ users had been working scientifically in the development of ELM for at least 3 years Any other detail: images were obtained by photographing the PSLs on 24 x 36‐mm colour‐slide film with ELM and without oil immersion (surface microscopy ISM) using a binocular stereomicroscope (M 650, Wild AG, Heerbrugg, Switzerland) at a final magnification of x 16 using flashlight illumination |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone (not further described) Disease‐positive: 57; disease‐negative: 183 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 57; BCC: 8 Severe dysplasia: 42; other 'Benign' : 133 |
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Flow and timing |
Reference interval: appears consecutive; "After photographing, all lesions were excised" Excluded participants: none reported |
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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? | 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 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? | No | ||
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? | Yes | ||
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? | |||
Low |