Gilmore 2010.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: 2003‐2008 Country: Austria Test set derived: NR. Training set: 65 melanomas and 65 dysplastic naevi, test set: 36 melanomas and 33 dysplastic naevi (included in review) |
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Patient characteristics and setting |
Inclusion criteria: atypical melanocytic lesions with polarised dermoscopic images; describes database as a "random, but representative, cohort" but does not describe method of selection Setting: secondary (general dermatology) Prior testing: unclear Setting for prior testing: NR Exclusion criteria: none reported Sample size (participants): number included: NR Sample size (lesions): number included: 199: derivation set n = 130; test set n = 69 Participant characteristics: none reported Lesion characteristics: none reported |
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Index tests |
Dermoscopy: no algorithm Method of diagnosis: dermoscopic images Prior test data: no further information used; described as blinded assessment Diagnostic threshold: NR; subjective impression; excise or not Diagnosis based on: single observer (n = 1) Observer qualifications: dermatologist Experience in practice: not described Experience with dermoscopy: not described; implies high or expert assessment. Conducted by 1 of the co‐authors |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Details: "lesions were excised and examined microscopically by expert dermatopathologists using standard: histopathologic diagnostic criteria" Disease‐positive: 36 = test set and 65 = derivation set; disease‐negative: 33 = test set and 65 = derivation set Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 36 test set and 65 derivation set Dysplastic naevi: 33 test set and 65 derivation set |
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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? | Unclear | ||
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? | 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? | 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? | Yes | ||
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 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 |