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. 2020 Dec 8;2020(12):CD013811. doi: 10.1002/14651858.CD013811

Van Hilsen 2013.

Study characteristics
Patient Sampling Method of sampling: selected, "A single examiner sorted through collected teeth and chose an assortment of teeth without evidence of cavitated lesions (ICDAS‐II 0–2)"
Included conditions: no cavitation and early lesions
Teeth: permanent premolars/molars
Sealants: excluded
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: USA
Setting: extracted teeth
Number of participants/teeth/sites: 45 teeth (3 damaged)
Prevalence: enamel 0.76, dentine 0.31
Index tests Category of test: Midwest
Sequence of test(s): index tests (visual using digital images, fluorescence, OCT) then reference standard
Examiner training and calibration: yes, "two examiners (E1, E2) were trained to use the Midwest Caries ID™ (MID) according to the manufacturer’s directions"
Teeth cleaning prior to examination: yes, "cleaned with pumice slurry to simulate a 'prophy cup' cleaning prior to assessment and copiously washed with water"
Tooth drying prior to examination: "Teeth were kept moist"
Threshold applied: sound = green/no beep, enamel = red/low frequency beep, dentine = red/high frequency beep
Device specifics: "The tip of the device was inserted vertically on the surface of each tooth and moved around slightly (without pressure) in the pits and fissure area"
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index test before reference standard
Training of examiner: not reported
Blinding to index test: yes
Multiple tests: no
Site selection: sectioned teeth
Target condition: sound, enamel, dentine
Flow and timing Participants with index test but no reference standard: 3
Participants with reference standard but no index test: 0
Time interval between tests: minimal
Participants receiving both tests but excluded from results: 0
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? No    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Low risk  
Are there concerns that the included patients and setting do not match the review question?     High
DOMAIN 2: Index Test (All)
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    
If multiple tests were applied were different examiners used for each (in vivo)? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 2: Index Test (Green fluorescence)
DOMAIN 2: Index Test (Blue fluorescence)
DOMAIN 2: Index Test (Red fluorescence)
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    
If multiple tests were applied were different examiners used for each (in vivo)? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
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? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
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? No    
Could the patient flow have introduced bias?   Low risk