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

Ko 2015.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: severity of condition unclear, "proximal surfaces with extensive cavities involving more than half of the proximal surface were excluded"
Teeth: permanent molars and premolars
Sealants: not reported
Surface: approximal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: South Korea
Setting: extracted teeth
Number of participants/teeth/sites: 100 teeth (5 were damaged so only 95 reported in results)
Prevalence: enamel 0.80, dentine 0.15
Index tests Category of test: QLF‐Digital Biluminator (QLF‐D, Inspektor Research Systems BV, Amsterdam, The Netherlands), using proprietary software (C3 v 1.16); "Pairs were formed with marginal ridges in contact to simulate the oral relationship"
Sequence of test(s): visual then radiograph followed by QLF
Examiner training and calibration: 1 calibrated dentist
Teeth cleaning prior to examination: cleaned of all soft tissues
Tooth drying prior to examination: dried with cotton wool
Threshold applied: calculated within study, sound < ‐13.8, enamel ‐13.8 to ‐28.3, dentine > ‐28.3
Device specifics: shutter speed 1‐20 seconds, aperture 13.0, ISO speed 1600, 10 cm between specimen and the device
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index test then reference standard
Training of examiner: not reported
Blinding to index test: unclear
Multiple tests: no
Site selection: sectioned teeth
Target condition: "enamel demineralization or a narrow surface zone of opacity", enamel or outer/inner dentine caries
Flow and timing Participants with index test but no reference standard: 5
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? Unclear    
Could the selection of patients have introduced bias?   High 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? No    
If multiple tests were applied were different examiners used for each (in vivo)? No    
Could the conduct or interpretation of the index test have introduced bias?   High 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)
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? No    
If multiple tests were applied were different examiners used for each (in vivo)? No    
Could the conduct or interpretation of the index test have introduced bias?   High risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 2: Index Test (Blue fluorescence)
DOMAIN 2: Index Test (Red fluorescence)
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    
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