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

Lussi 2001.

Study characteristics
Patient Sampling Method of sampling: dentists selected participants but method or criteria unclear
Included conditions: aims of inclusion not clearly stated
Teeth: not reported
Sealants: not reported
Surface: occlusal
Patient characteristics and setting Age: mean age 19.8 years
Sex: not reported
Ethnicity: not reported
Country: Switzerland and Germany
Setting: clinical setting
Number of participants/teeth/sites: 240 participants/332 surfaces
Prevalence: enamel 0.67, dentine 0.59
Index tests Category of test: DIAGNOdent
Sequence of test(s): visual, radiograph then DIAGNOdent
Examiner training and calibration: experienced examiners, with training
Teeth cleaning prior to examination: "Professional cleaning of the tooth surfaces was not carried out. If needed, plaque remnants were removed from the fissures using an explorer"
Tooth drying prior to examination: air dried
Threshold applied: calculated in study, 0‐13: no caries; values 14‐20: enamel caries; values > 20: dentinal caries
Device specifics: tip A
Target condition and reference standard(s) Category: excavation for those deemed to be appropriate, not clearly reported how this decision was made, it appears that visual, radiograph, and DIAGNOdent were combined to inform this decision
Sequence of index test and reference standard: visual, radiograph then DIAGNOdent, all before excavation
Training of examiner: experienced clinicians
Blinding to index test: no ‐ reference standard appears to be directly informed by the index test
Multiple tests: yes
Site selection: via clinical decision making and combined series of tests
Target condition: sound, enamel, inner/outer dentine
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? 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? No    
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)
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? 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 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? No    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   High risk