Menzies 1996.
Study characteristics | |||
Patient sampling |
Study design: unclear. Abstract describes including a random sample of excised lesions from a larger database Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: Australia Test set derived: NR; describes 'division' into a training set and a test set |
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Patient characteristics and setting |
Inclusion criteria: PSLs from the Sydney Melanoma Unit with dermoscopic images and histological diagnoses; melanomas and randomly selected clinically atypical non‐melanoma lesions were included Setting: specialist unit (skin cancer/PLC) Prior testing: selected for excision Setting for prior testing: specialist unit (skin cancer/PLC) Exclusion criteria: unequivocal non‐melanoma excluded Sample size (participants): number included: NR Sample size (lesions): number included: 385 Participant characteristics: none reported Lesion characteristics: none reported |
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Index tests |
Dermoscopy: Menzies criteria Method of diagnosis: dermoscopic images Prior test data: no further information used Diagnostic threshold: presence of 2 negative features and at least 1 positive feature. Negative features: point and axial symmetry of pigmentation or presence of only a single colour. Positive features of melanoma: multiple (5‐6) colours; blue‐white veil; multiple brown dots; multiple blue/grey; peripheral black dots or globules; a broadened network; pseudopods; radial streaming; scar‐like Diagnosis based on: unclear (n = NR) Observer qualifications: NR; likely dermatologists Experience in practice: not described Experience with dermoscopy: not described |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone (not further described) Disease‐positive: 107; disease‐negative: 278 Target condition (final diagnoses) Melanoma (invasive): 107; BCC: 18 Ephelis/lentigo 17; SK: 23; benign acquired naevi ‐ 58; dysplastic naevi ‐ 105; blue naevi 11; SN 6; spindle cell naevus 2; DF 2; hemangioma 13; solar keratosis 9; other 14 |
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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? | Unclear | ||
Did the study avoid inappropriate exclusions? | Yes | ||
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? | |||
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? | Yes | ||
Was the test interpretation carried out by an experienced examiner? | Unclear | ||
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? | 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 |