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

Jung 2018.

Study characteristics
Patient Sampling Method of sampling: consecutive
Included conditions: no cavitation and early lesions
Teeth: permanent
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: minimum age of 18 years
Sex: not reported
Ethnicity: not reported
Country: South Korea
Setting: extracted teeth
Number of participants/teeth/sites: 94 participants/791 teeth
Prevalence: enamel 0.47, dentine 0.14
Index tests Category of test: QLF images
Sequence of test(s): index tests performed (visual then QLF) prior to histology
Examiner training and calibration: yes ‐ single calibrated examiner
Teeth cleaning prior to examination: professionally by therapists
Tooth drying prior to examination: "sufficient drying"
Threshold applied: sound, initial caries, enamel caries, dentine
Device specifics: not reported clearly ‐ QS‐Occlusal software algorithm was used to determine the levels of disease D1 = 0/1, D2 = 1/2, D3 = 3/4
Target condition and reference standard(s) Category: visual ICDAS classification
Sequence of index test and reference standard: visual examination completed prior to QLF with histology following
Training of examiner: not reported
Blinding to index test: unclear ‐ examiner not blinded between visual and QLF, although 2 weeks passed between assessments
Multiple tests: yes
Site selection: marked on a photograph prior to index test, then sectioned teeth
Target condition: ICDAS codes
Flow and timing Participants with index test but no reference standard: 0
Participants with reference standard but no index test: lack of clarity on true reference standard
Time interval between tests: 2 weeks
Participants receiving both tests but excluded from results: 0
Comparative  
Notes D1 threshold used as labelled in table 4 as 0 versus 1‐4
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    
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? No    
If a threshold was used, was it pre‐specified? Yes    
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?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     High
DOMAIN 2: Index Test (Green fluorescence)
Were the index test results interpreted without knowledge of the results of the reference standard? No    
If a threshold was used, was it pre‐specified? Yes    
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?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     High
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? No    
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?   High 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? Unclear    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Unclear risk