Jung 2018.
Study characteristics | |||
Patient Sampling | Method of sampling: consecutive Included conditions: no cavitation and early lesions Teeth: permanent Sealants: no Surface: occlusal |
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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 |
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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 |
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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 |
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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 |
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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 |