Blum 2003b.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: September 1998‐December 1999; lesions overlap with Blum 2004b; data only included in algorithm comparison and not in primary analysis. Country: Germany |
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Patient characteristics and setting |
Inclusion criteria: all lesions of patients with multiple atypical naevi excised due to suspicious clinical and/or dermoscopic features were included Setting: specialist unit (skin cancer/PLC) Prior testing: clinical and/or dermatoscopic suspicion Setting for prior testing: specialist unit (skin cancer/PLC) Exclusion criteria: lesions located on soles, palms, subungual and mucosal sites were excluded Sample size (participants): number included: 205 Sample size (lesions): number eligible: 254/number included: 254 Participant characteristics: median age: 39.2 (1.6‐86.4 years); male: 97 (47.3%) Lesion characteristics: NR |
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Index tests |
Dermoscopy: new algorithm (based on criteria of Hofmann‐Wellenhof 2001) Method of diagnosis: dermoscopic images Prior test data: unclear; looks like blinded test interpretation Diagnostic threshold: lesions were classified into six different types according to morphological criteria of the new classification of atypical naevi (Clark naevi): reticular, globular and homogeneous or combinations of two of these types (Hofmann‐Wellenhof 2001). If reticular, globular and homogeneous structures were found in one melanocytic lesion, this lesion was classified as a 3‐structure type Diagnosis based on: consensus (2 observers); n = 2 Observer qualifications: NR; likely dermatologists, "All images were viewed by two investigators" 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 Disease‐positive: 75 MM; disease‐negative: 179 Target condition (final diagnoses) Melanoma (invasive): 63; melanoma (in situ): 12 Benign naevus: recurrent naevus 6; SN or Reed naevus 6; congenital naevus 4; blue naevus 3; naevus without dysplasia 64; dysplastic naevus 96 |
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Flow and timing |
Excluded participants: none reported Time interval between index and reference: assumed consecutive, "All patients gave written informed consent for the digital documentation and the following operation under local anaesthesia" |
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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? | No | ||
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? | No | ||
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 | ||
High | 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? | Yes | ||
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? | Yes | ||
Low |