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

Chong 2003.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: no cavitation and early lesions
Teeth: permanent premolars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: 12 to 15 years
Sex: not reported
Ethnicity: not reported
Country: Australia
Setting: extracted teeth
Number of participants/teeth/sites: 320 teeth
Prevalence: enamel 0.50, dentine 0.35
Index tests Category of test: DIAGNOdent
Sequence of test(s): index tests (visual, radiograph then DIAGNOdent) prior to reference standard
Examiner training and calibration: not reported
Teeth cleaning prior to examination: brush and slurry
Tooth drying prior to examination: 5 seconds air spray
Threshold applied: < 5 sound, 5‐25 enamel, 26‐35 dentine, > 35 advanced dentine
Device specifics: not reported
Target condition and reference standard(s) Category: visual
Sequence of index test and reference standard: reference standard then index test
Training of examiner: not reported
Blinding to index test: yes
Multiple tests: yes
Site selection: not reported
Target condition: visual: C0 sound, C1 no opacity, C2 opacity and not sticky, C3 opacity and sticky, C4 frank cavitation
Flow and timing Participants with index test but no reference standard: 0
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 Data used for fluorescence versus visual as this is the most clinically relevant, no sites identified as sound by index test
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?   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? 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?   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)
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? 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?   High 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? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? No    
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? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk