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 |
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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 |
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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 |
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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 |
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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 |
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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 |