Rubegni 2012.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: January2008‐December 2010 Country: Italy |
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Patient characteristics and setting |
Inclusion criteria: all palmoplantar PSLs observed and removed because of the presence of clinical and/or dermoscopic suspicious features and in the absence of any clear benignity pattern (parallel furrow pattern, lattice‐like pattern or fibrillar pattern). Setting: secondary (general dermatology) Prior testing: clinical and/or dermatoscopic suspicion Setting for prior testing: secondary (general dermatology) Exclusion criteria: non‐acral lesions; site of lesion in volar skin of the folds near the toes; lesion size > 26 mm diameter; non‐melanocytic appearance; elevated or ulcerated appearance Sample size (participants): number included: 107 Sample size (lesions): number included: 107 Participant characteristics: mean age: 49.8 years (women); 44.9 years (men); range 19‐73 years; male: 58.9%; ethnicity white: 100% Lesion characteristics 78 on soles and 19 on palms; 9 (36%) melanomas ≤ 0.75 mm (incl 4 in situ); 11 (44%) 0.76‐1.5 mm in 11/25 lesions; 5 (20%) ≥ 1.50 mm |
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Index tests |
Dermoscopy: pattern analysis; 3‐step algorithm for palmoplantar lesions (Koga 2011) Method of diagnosis: dermoscopic images Prior test data: no further information used Diagnostic threshold: clinical diagnosis (melanoma/no melanoma). For the 3‐step algorithm the conventional options are "removal, follow‐up or no follow‐up"; the latter 2 were combined under the term ‘no melanoma’ for study purposes Diagnosis based on: single observer (n = 2; one per algorithm) Observer qualifications: dermatologist Experience in practice: high Experience with dermoscopy: high; 2 dermatologists with 20 years’ experience in dermoscopy Any other detail: ELM images achieved with the DB‐Mips System; (magnification x 16) |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Details: "Histopathological diagnosis was based on the criteria of the National Institute of Health Consensus Conference" Disease‐positive: 25; disease‐negative: 82 Target condition (final diagnoses) Melanoma (invasive): 21; melanoma (in situ): 4 'Benign' diagnoses: 82 |
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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? | 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? | Yes | ||
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? | 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 |