Zaumseil 1983.
Study characteristics | |||
Patient sampling |
Study design: CS Data collection: NR Period of data collection: 1976‐1981 Country: Germany |
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Patient characteristics and setting |
Inclusion criteria: skin lesions undergoing excision Setting: secondary (not further specified) Prior testing: selected for excision (no further detail) Setting for prior testing: specialist unit (skin cancer clinic/PLC) Described as 'skin clinic' Exclusion criteria: disagreement between evaluators on tumour histological classification. Those in which the histological diagnosis was 'unclear' were excluded, melanoma metastases were excluded Sample size (participants): NR Sample size (lesions): number included: 7063 Participant characteristics: none reported Lesion characteristics: none reported |
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Index tests |
VI: no algorithm Method of diagnosis: in‐person diagnosis Prior test data: N/A, in‐person diagnosis Diagnostic threshold: primary diagnosis of melanoma (method of Kopf 1975 was cited) Diagnosis based on: single observer (n = NR) Observer qualifications: NR Experience in practice: not described Experience with index test: not described |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Disease positive: 337; disease negative: 6726 Target condition (final diagnoses) Melanoma (invasive or in situ): 337 Other diagnoses only listed for the 89 false‐positives: 23 benign naevi; 13 BCC; 12 blue nevus; 11 angiomatosis; 10 SK; 6 histiocytoma; 4 Spitz nevus; 4 lentigo; 3 Bowen's disease; 1 acrospiroma; 1 keratinizing papilloma |
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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? | 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 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? | 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? | 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? | 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 |
ABCD(E): asymmetry, border, colour, differential structures (enlargement); AK: actinic keratosis; AMN: atypical MN; BCC: basal cell carcinoma; CAD: computer‐assisted diagnosis; CCS: case‐controlled study; CD: compact disc; CM: cutaneous melanoma; CMM: cutaneous malignant melanoma; CS: case series; cSCC: cutaneous squamous cell carcinoma; DF: dermatofibroma; ELM: epiluminescence microscopy; FN: false‐negative; FP: false‐positive; GP: general practitioner; H&E: haematoxylin and eosin stain; LPLK: lichen planus‐like keratosis; LS: lentigo simplex; MM: malignant (invasive) melanoma; MN: melanocytic naevi; MSDSLA: multispectral digital skin lesion analysis device; N/A: not applicable; NMLs: non‐melanocytic lesions; NR: not reported; PCPs: primary care providers; PLC: pigmented lesion clinic; PSL: pigmented skin lesion; RCM: reflectance confocal microscopy; RCT: randomised controlled trial; SCC: squamous cell carcinoma; SD: standard deviation; SDDI: short‐term sequential digital dermoscopy imaging; SK: seborrhoeic keratosis; SSM: superficial spreading melanoma; SVS: support vector system; VI: visual inspection; 7FFM: seven features for melanoma