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. 2018 Dec 4;2018(12):CD013191. doi: 10.1002/14651858.CD013191

Curchin 2011.

Study characteristics
Patient sampling Study design: case series
Data collection: prospective
Period of data collection: January 2010 to May 2010
Country: Australia
Patient characteristics and setting Inclusion criteria: people from Dermatology Department's minor excision booking list; not further described
Setting: secondary (general dermatology)
Prior testing: selected for excision (no further detail)
Setting for prior testing: unspecified
Exclusion criteria: none reported
Sample size (participants): number included: 42
Sample size (lesions): number included: 50
Participant characteristics: none reported
Lesion characteristics: none reported
Index tests RCM: Vivascope 1500; RCM score (Pellacani 2007) and LM score for suspected LM of the face (Guitera 2010)
Method of diagnosis: in‐person diagnosis
Prior test data: dermoscopy "dermoscopic and RCM images were aligned over the top of each other so that correlation between the two could be made."
Diagnostic threshold: for melanoma – RCM score: ≥ 3; threshold for LM score for suspected LM of the face was not described (Guitera 2010). Observer diagnosis for SCC/BCC; RCM features listed
Diagnosis based on: single observer; (n = 1?)
Observer qualifications: NR
Experience in practice: not described
Experience with index test: low experience/novice users; analysis was performed by a novice to RCM analysis after completing an RCM analysis course in Modena, Italy.
Target condition and reference standard(s) Type of reference standard: histological diagnosis alone
Details: no further details provided
Disease positive: 21; disease negative: 29
Target condition (final diagnoses): melanoma (invasive): 12; melanoma (in situ): 1; BCC: 9; cSCC: 6 (included SK or AK, or both); 'benign' diagnoses: 23
Flow and timing Time interval to reference test: 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? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Are the included participants and chosen study setting appropriate? Unclear    
Did the study avoid including participants with multiple lesions? No    
    Low High
DOMAIN 2: Index Test Reflectance confocal microscopy
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? Yes    
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    
    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    
Were the reference standard results interpreted without knowledge of the referral diagnosis? Unclear    
    Unclear 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    
Was the minimum clinical follow‐up after application of index test(s) adequate?      
If more than one algorithm evaluated for the same test, was the interval between application of the different algorithms 1 month or less?      
    Low