Piccolo 2002a.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: NR; 6‐month period Country: Italy |
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Patient characteristics and setting |
Inclusion criteria: pigmented lesions excised because of equivocal dermoscopic findings or at the patient’s request Setting: secondary (general dermatology); from authors' institution Prior testing: dermatoscopic suspicion; patient request for evaluation/excision Setting for prior testing: NR Exclusion criteria: none reported Sample size (participants): number included: 289 Sample size (lesions): number included: 341 Participant characteristics: mean age 33.6 years, range 3–83 years; male: 127 (43.9%); Fitzpatrick phototype I‐II (31.4%); type III (42%); type IV‐V (26.4%) Lesion characteristics: none reported |
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Index tests |
Dermoscopy: no algorithm Method of diagnosis: clinical photographs and dermoscopic images. Cases were clinically and dermoscopically evaluated on a high‐resolution colour monitor, in a random sequence Prior test data: none; appears to be based on images only Diagnostic threshold: correct diagnosis of melanoma Diagnosis based on: single observer (n = 2) Observer qualifications: dermatologist; (dermatology?) resident Experience in practice: high, dermatologist had 5 years of experience; low, resident with minimal training in PSLs Experience with dermoscopy: high and low (resident had 6 months of experience, comprising 8 h of specialised training on 3 consecutive days and 2 h/week in routine dermoscopy) |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Details: "All excised lesions were examined histopathologically by a dermatopathologist" Disease‐positive: 13; disease‐negative: 328 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 13 Sebhorrheic keratosis: 3; benign naevus: 316; dFs 7; angiomas 2 |
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Flow and timing | Time interval to reference test: NR | ||
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? | No | ||
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? | Unclear | ||
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 |