Dummer 1993.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: prospective; dermoscopic images assessed remotely from the patient Period of data collection: 12 month period (year/dates NR) Country: Germany |
||
Patient characteristics and setting |
Inclusion criteria: patients with skin lesions difficult to diagnose clinically Setting: secondary Prior testing: clinical suspicion of malignancy without dermatoscopic suspicion Setting for prior testing: specialist unit (skin cancer/PLC) a type of specialist care‐ dermatology based clinic Exclusion criteria: patients who had excisions performed in individual practices or where there was no histology or cases that were so obvious they didn't need to have further investigation (clearly benign) Sample size (participants): NR Sample size (lesions): number eligible: 824; number included: 771 Participant characteristics: none reported Lesion characteristics: none reported |
||
Index tests |
VI: no algorithm Method of diagnosis: in person Prior test data: in person Other test data: dermoscopic images viewed separately Diagnostic threshold: NR Diagnosis based on: single observer; (n = 2 or 3) Observer qualifications: unclear; clinician based in dermatology clinic (assumed dermatologist) Experience in practice: unclear Experience with index test: unclear Dermoscopy: pattern analysis Method of diagnosis: dermoscopic images Prior test data: unclear Diagnostic threshold: NR Observers: as described above |
||
Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Disease‐positive: 23 MM; disease‐negative: 748 benign Target condition (final diagnoses) Invasive melanoma: 23 Benign naevus 706; SK 4; benign non‐melanocytic naevus 32 |
||
Flow and timing |
Excluded participants: 53 non‐melanocytic lesions not included in the final analysis (no melanomas present in this group) Time interval to reference test: NR Time interval between index test(s): 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? | Yes | ||
Are the included patients and chosen study setting appropriate? | No | ||
Did the study avoid including participants with multiple lesions? | Unclear | ||
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 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? | |||
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 | Unclear | ||
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? | No | ||
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? | Unclear | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | No | ||
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? | |||
High |