Stolz 1994a.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: from 1989‐1991 Country: Germany Test set derived: 157 cases were randomly divided into a test and training set. |
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Patient characteristics and setting |
Inclusion criteria: equivocal melanocytic skin lesions < 9 x13 mm, melanoma tumour thickness of ≤ 1 mm and melanoma Clark's ≤ level III Setting: secondary (general dermatology); Univerisity of Munich Department of 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 eligible: 650 cases/number included: 157 lesions Participant characteristics: none reported Lesion characteristics: melanoma thickness: 50 ≤ 0.4 mm; 30 ≤ 0.75 mm; 15 ≤ 1 mm |
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Index tests |
Dermoscopy: ABCD Method of diagnosis: dermoscopic images; colour prints examined for 31 dermoscopic features, most listed in the guidelines of the Consensus Conference of Surface Microscopy held in Hamburg in 1989 (Bahmer 1990); described as a "blind study" Prior test data: no further information used Diagnostic threshold: > 5.45; multivariate analysis of training set data identified 8 features with the lowest P values; the total dermoscopic score (TDS) was then developed based on: asymmetry score x 1.3 + Border score x 0.1 + Colour score x 0.5 + Differential structure score x 0.5. New formula then evaluated on the test set of images. Diagnosis based on: single observer (n = 1) Observer qualifications: NR; co‐author, assumed to be dermatologist 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 Details: histology undertaken by 2 independent histopathologists Disease‐positive: test set = 48; disease‐negative: test set = 31 Target condition (final diagnoses) Melanoma (invasive): 85; melanoma (in situ): 10 'Benign' diagnoses: 62 melanocytic naevi; 17 junctional; 40 compound; 5 dermal |
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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? | 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 |