Krahn 1998.
Study characteristics | |||
Patient sampling |
Study design: CS Data collection: prospective Period of data collection: NR Country: Germany |
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Patient characteristics and setting |
Inclusion criteria: excised PSLs Setting: secondary (general dermatology) Prior testing: NR Setting for prior testing: NR Exclusion criteria: none reported Sample size (participants): number included: 80 Sample size (lesions): number included: 80 Participant characteristics: none reported Lesion characteristics range in thickness (melanomas) 0.18‐1.9 mm; 29/39 < 0.76 mm; 7/39 0.76‐1.5 mm; 3/39 > 1.5 mm |
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Index tests |
VI: no algorithm reported Method of diagnosis: in‐person diagnosis Prior test data: unclear Other test data: dermoscopy undertaken by same clinician(s) subsequent to clinical evaluation Diagnostic threshold: NR; no details Diagnosis based on: single observer (n = 1) Observer qualifications: NR, likely dermatologist Experience in practice: not described Experience with index test: not described Dermoscopy: evaluated in same study; no algorithm |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone including histometrics Disease positive: 39; disease negative: 41 Target condition (final diagnoses) Melanoma (invasive): 39 (SSM, lentigo MM, nodular M) Benign naevus: 37 common naevus; 3 dysplastic nevus, 1 Spitz naevus |
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Flow and timing |
Excluded participants: none reported Time interval to reference test: NR Time interval between index test(s): 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? | Unclear | ||
Are the included patients and chosen study setting appropriate? | No | ||
Did the study avoid including participants with multiple lesions? | Yes | ||
Unclear | 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? | 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? | 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 | ||
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 |