di Meo 2016.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: February‐December 2014 Country: Italy |
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Patient characteristics and setting |
Inclusion criteria: melanocytic skin lesions that underwent excision Setting: secondary (general dermatology) Prior testing: selected for excision (no further detail) Setting for prior testing: secondary (general dermatology) Exclusion criteria: acral and mucosal lesions; dysplastic naevi excluded; disagreement between evaluators on tumour histological classification ‐ lesions that did not meet at least 2 consents were excluded; poor‐quality index test image (considered under flow and timing) Sample size (participants): number included: 125 Sample size (lesions): number included: 125 Participant characteristics: mean age: men 44.6 years; women 50.0 years; male: 61; 58% Lesion characteristics: thickness ≤ 1 mm: all 32 melanomas |
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Index tests |
Dermoscopy 3PCL; scored 3‐point '4‐point checklist' (authors' own scoring); CASH algorithm Method of diagnosis: dermoscopic images Prior test data: no further information used Diagnostic threshold: 3PCL ≥ 2 criteria present; CASH score > 7; 4‐point checklist > 2 Diagnosis based on: unclear; lesions were "randomly assessed by two independent dermatologists" not clear if average or consensus; n = 2 Observer qualifications: dermatologist Experience in practice: high Experience with dermoscopy: high; dermatologists with > 7 years of experience in dermoscopy Any other detail: The 3PCL criteria: asymmetry in colour and/or structures in 1/2 axes, pigmented network with thickened lines and irregular distribution, and any blue and/or white structure within the lesion CASH algorithm has 4 criteria: colour, architectural disorder, symmetry and homo/heterogeneity. Scoring described in detail 4‐point checklist; doubled all 3 criteria of the 3PCL and chose the one conferring more sensitivity, specificity and accuracy (symmetry parameter doubled) |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone All lesions were excised and independently analysed by 2 dermatopathologists. The diagnosis of dysplastic naevus was based on the histopathological diagnostic criteria set by the World Health Organization Melanoma Programme (Clemente 1991). It was considered as a benign lesion Disease‐positive: 32; disease‐negative: 93 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 32 Mild/moderate dysplasia: 50; benign naevus: 43 |
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Flow and timing |
Excluded participants: dysplastic naevi (n = 50) excluded from 2x2; poor‐quality index test images ‐ exclusion criterion Interval between index and reference standard: not clearly 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? | Yes | ||
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? | Unclear | ||
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? | Yes | ||
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? | 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? | No | ||
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? | Yes | ||
High |