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

Yoon 2017.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: "large restorations, and extensive caries involving more than half of the proximal surfaces were excluded"
Teeth: permanent 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: 102 teeth
Prevalence: any caries 0.63, dentine level not reported
Index tests Category of test: DIAGNOdent and QLF‐D (QLF‐D Biluminator 2, Inspektor Research Systems)
Sequence of test(s): radiograph (reference standard) followed by QLF and DIAGNOdent
Examiner training and calibration: "performed by a single skilled examiner who had sufficient training"
Teeth cleaning prior to examination: "distilled water to remove soft tissue and plaque"
Tooth drying prior to examination: air‐dried for 5 seconds
Threshold applied:
DIAGNOdent: "value was 10 or higher"
QLF: "fluorescence loss (ΔF) was measured"....."caries was diagnosed when the maximum QLF "diagnosed as caries when the fluorescence loss was lower than ‐13.8"
Device specifics:
DIAGNOdent: probe A
QLF: "shutter speed of 1/15 s, aperture value of 8.0, ISO speed of 1600, white balance as manual (white light) or daylight (blue light)"
Target condition and reference standard(s) Category: bitewing radiograph
Sequence of index test and reference standard: prior to index tests
Training of examiner: yes but not clearly reported
Blinding to index test: done prior to index tests
Multiple tests: no
Site selection: not reported
Target condition: sound, enamel or dentine caries
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  
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?   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)
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?     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? No    
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?   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