Soyer 1995.
Study characteristics | |||
Patient sampling |
Study design: CS Data collection: unclear Period of data collection: NR Country: Austria |
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Patient characteristics and setting |
Inclusion criteria: PSL, difficult to diagnose on clinical grounds alone Setting: specialist unit (skin cancer clinic/PLC) Prior testing: clinical suspicion Setting for prior testing: secondary (general dermatology); referred by dermatologists or general physicians Exclusion criteria: none reported Sample size (participants): NR Sample size (lesions): number included: 159 Participant characteristics: none reported Lesion characteristics "23 melanomas with a Breslow index of ≤ 0.75 mm, 13 melanomas with a Breslow index ≥ 0.76 mm and ≤ 1.5 mm, 12 melanomas with a Breslow index ≥ 1.51 mm and ≤ 3.5 mm, 2 melanomas with a Breslow index of ≥ 3.5 mm." |
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Index tests |
VI: no algorithm Method of diagnosis: in‐person diagnosis Prior test data: N/A in‐person diagnosis Other test data: dermoscopy undertaken by same clinician(s) subsequent to clinical evaluation Diagnostic threshold: NR Diagnosis based on: n = 2 (1 or 2 per lesion) Observer qualifications: dermatologist Experience in practice: not clearly described; assumed to be high; “Each lesion was examined clinically by .. one of the authors .. and a clinical diagnosis was recorded.” “After application of a drop of immersion oil, each lesion was examined dermoscopically …; the examination was performed by a dermatologist expert in dermoscopy and a dermoscopic diagnosis was recorded” Experience with index test: not described Other detail: "Photographic documentation was performed using an incident light stereomicroscope (Wild M 650) equipped with a Minolta XG‐M camera" Dermoscopy: evaluated in same study; pattern analysis |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Disease positive: 65 (41%); disease negative: 94 (59%) Target condition (final diagnoses) Melanoma (invasive): 50; melanoma (in situ): 15 BCC: pigmented BCC (3) SK: 18; Clark's naevus of dysplastic naevus (61 cases); lentigo actinica lentigo (2), pigmented AK (4), angioma (3), angiokeratoma (2) |
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Flow and timing |
Excluded participants: none reported Time interval to reference test: NR |
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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? | Yes | ||
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 | ||
Unclear | Unclear | ||
DOMAIN 2: Index Test Visual Inspection ‐ in‐person | |||
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? | Yes | ||
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 | ||
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 |