Westerhoff 2000.
Study characteristics | |||
Patient sampling |
Study design: case‐control (for lesion selection; study was an RCT of dermoscopy training for PCPs) Data collection: retrospective Period of data collection: NR Country: Australia |
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Patient characteristics and setting |
Inclusion criteria: clinically atypical PSLs; 50 invasive melanomas and 50 non‐melanomas randomly selected from the Sydney Melanoma Unit PSLs image database Setting: specialist unit (lesion selection) Prior testing: selected for excision or followed up Setting for prior testing: specialist unit (skin cancer/PLC) Exclusion criteria: none reported Sample size (participants): number included: NR Sample size (lesions): number included: 100 Participant characteristics: none reported Lesion characteristics: median Breslow thickness 0.6 mm |
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Index tests |
VI: no algorithm Method of diagnosis: clinical photographs Prior test data: unclear; all participants "were instructed not to look at the surface microscopic image until they had scored the clinical image" Diagnostic threshold: NR Diagnosis based on: average (n = 37; 74 practising primary care practitioners randomised to dermoscopy education intervention or not). Diagnoses were recorded for both groups of GPs at baseline (pre‐test) and after the training intervention had been administered to the intervention group (post‐test), resulting in 8 sets of 2x2 data based on interpretation of the same set of 100 lesions; post‐test data for the intervention group of GPs was used for the VI analysis. Observer qualifications: GP Experience in practice: considered to be low; only practitioners who had had no formal training with surface microscopy and did not use a surface microscope in their clinical practice were included. Experience with dermoscopy: low experience/novice users (non‐training arm); "Trained" for the intervention arm Other detail: camera designed for close‐up clinical photography (Elicar Macrolens, Japan) Dermoscopy: no algorithm (non‐training arm); Menzies criteria (training/intervention arm) Method of diagnosis: dermoscopic images Prior test data: diagnosis was first based on the clinical image and then the dermoscopic image for each lesion. Diagnostic threshold: NR; intervention arm instructed in Menzies criteria Test observers: as above Any other detail: dermoscopy at x10 magnification with a Dermphot camera (Heine Ltd) using oil at the skin‐lens interface. Dermoscopy training: the education intervention included provision of the Menzies and colleagues pictorial atlas which reportedly describes the Menzies approach to dermoscopy diagnosis of melanoma (Menzies 1996); they also attended a 1‐h presentation on dermoscopy reviewing the Menzies approach and including a quiz based on images of 25 different PSLs Post‐training experience: < 6 months; the median interval between pretest and education intervention was 46 days (range 5‐155). Median interval from education intervention to post‐test was 23 days (range 2‐54). Training format: in‐person teaching; written materials |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis + follow‐up Histology: all the lesions except 2 had been excised after photography and subjected to histopathological examination. Disease‐positive: 50; disease‐negative: 48 Clinical follow‐up + histology of suspicious lesions: the two benign PSLs that had not been excised were monitored over a longer period of time and had shown no morphological change. Length of follow‐up: NR; disease‐positive: 0/disease‐negative: 2 Target condition (final diagnoses) Melanoma (invasive): 50/'Benign' diagnoses: 50 |
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Flow and timing |
Excluded participants: none reported Time interval to reference test: "All the lesions except two had been excised after photography" |
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Comparative |
Blinding between tests: observers were instructed not to look at the dermoscopy image until they had scored the clinical image Time interval between index test(s): NR; lesions described as "excised after photography" therefore assumed consecutive |
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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? | 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? | 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? | Unclear | ||
For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others? | Yes | ||
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? | No | ||
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? | Yes | ||
Did all patients receive the same reference standard? | No | ||
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? | Unclear | ||
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 | |||
DOMAIN 5: Comparative | |||
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies? | No | ||
Was the interval between application of the index tests less than one month? | Yes | ||
Were all tests applied and interpreted in a clinically applicable manner? | No | ||
Low | High |