Skvara 2005.
Study characteristics | |||
Patient sampling |
Study design: case‐control Data collection: retrospective image selection/prospective interpretation Period of data collection: July 1996‐September 1996 Country: Austria |
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Patient characteristics and setting |
Inclusion criteria: consecutive lesions excised due to changes over time during digital dermoscopy follow‐up (appear to be from patients with multiple melanocytic naevi); all lesions were assessed for presence of dermoscopic characteristics and all melanomas + random sample of same number of benign were assessed by dermoscopic algorithms (included in review) Setting: secondary (general dermatology) Prior testing: NR Setting for prior testing: unspecified Exclusion criteria: location/site of lesion ‐ palmar, plantar, facial lesions; lesion size lesions that exceeded maximum field of view of the electronic camera Sample size (participants): NR Sample size (lesions): number included: 126 Participant characteristics: none reported Lesion characteristics none reported |
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Index tests |
Dermoscopy 7PCL and ABCD Method of diagnosis: dermoscopic images presented on a computer screen Prior test data: no further information used Diagnostic threshold: ABCD score > 4.75; 7PCL score > 2 Diagnosis based on: single observer (n = 2) Observer qualifications: dermatologist Experience in practice: assumed high; paper describes assessment of baseline images for dermoscopic criteria by "2 experienced dermatologists"; "additionally, the baseline images of (a subgroup of lesions) were evaluated by 2 blinded investigators). These appear to be separate groups of observers but have assumed similar levels of experience. Experience with dermoscopy: assumed high (as above) |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone (but all lesions followed up) Details: "standard: histopathology" following lesion changes over time Disease‐positive: 63; disease‐negative: 63 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 63 Benign naevus: 63 |
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Flow and timing |
Participant exclusions: none reported Index test to reference standard interval: lesions suggestive of melanoma at baseline were removed at the patient’s initial visit (immediately); the others were followed up for 3‐6 months until lesion changes initiated excision |
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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? | No | ||
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? | Unclear | ||
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? | Unclear | ||
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? | 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? | Yes | ||
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 |