Troyanova 2003.
Study characteristics | |||
Patient sampling |
Study design: CCS Data collection: retrospective image selection/prospective interpretation Period of data collection: NR Country: NR |
||
Patient characteristics and setting |
Inclusion criteria: Images of PSLs ≤ 13 mm in diameter selected for a dermoscopy training study Setting: training study Prior testing: NR Setting for prior testing: NR Exclusion criteria: NR Sample size (participants): NR Sample size (lesions): number included: 50 lesions Participant characteristics: NR Lesion characteristics: melanoma thickness: ≤ 1 mm: 100% |
||
Index tests |
VI: no algorithm Method of diagnosis: clinical photographs and dermoscopic images Other test data: dermoscopic images presented to observer subsequent to diagnosis using clinical images alone. Prior test data: no further information used Diagnostic threshold: NR Diagnosis based on: average; n = 32 Observer qualifications: dermatologist Experience in practice: high experience or ‘Expert’ Experience with index test: low experience/novice users; experienced in PSL field but not ELM Dermoscopy: evaluated in same study; no algorithm |
||
Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Disease positive: 25; disease negative: 25 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 25 'Benign' diagnoses: 25 "not melanoma" |
||
Flow and timing |
Excluded participants: none reported 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? | No | ||
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? | Unclear | ||
High | High | ||
DOMAIN 2: Index Test Visual inspection ‐ 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? | No | ||
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? | 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? | 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 |