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

Kim 2017.

Study characteristics
Patient Sampling Method of sampling: not clearly reported
Included conditions: severity of condition unclear, "subjects with 1 or more proximal caries surfaces detected visually or radiographically were included in the study", restorations were included
Teeth: permanent molars and premolars
Sealants: not reported
Surface: approximal
Patient characteristics and setting Age: 19 to 60 years
Sex: 55% male
Ethnicity: not reported
Country: South Korea
Setting: extracted teeth
Number of participants/teeth/sites: 65 teeth/280 sites
Prevalence: enamel 0.61, dentine 0.20
Index tests Category of test: QLF‐Digital Biluminator 2+ (QLF‐D, Inspektor Research Systems BV, Amsterdam, The Netherlands), 2 methods one using QA2 software, the second using fluorescence images interpreted by an examiner: "Normal white‐light images and sequential fluorescence images were captured with a “live view” enabled full‐frame sensor digital SLR camera"
Sequence of test(s): visual then radiograph followed by QLF, radiograph was the reference standard
Examiner training and calibration: 1 trained examiner completed all index tests and reference standard
Teeth cleaning prior to examination: full‐mouth scaling and polishing
Tooth drying prior to examination: not reported
Threshold applied: method used for fluorescence image method: shadow and no red fluorescence (Q0), an irregular dark shadow but no red fluorescence (Q1), faint red fluorescence limited to 1/3 of the buccolingual width (Q2), and strong red fluorescence over 1/3 of the buccolingual width (Q3)
Target condition and reference standard(s) Category: radiograph
Sequence of index test and reference standard: reference standard prior to index test
Training of examiner: not reported, but experienced
Blinding to index test: no
Multiple tests: no
Site selection: approximal surfaces
Target condition: sound, outer/inner enamel, outer/inner dentine
Flow and timing Participants with index test but no reference standard: 15
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 the fluorescence images method as the 2x2 figures were not available for the software method
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
Could the selection of patients have introduced bias?   Unclear 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)
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 (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? 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? No    
Could the patient flow have introduced bias?   High risk