Lederer 2018.
Study characteristics | |||
Patient Sampling | Method of sampling: selected Included conditions: sound or early enamel lesions; "either an intact, sound interproximal surface or non‐cavitated proximal caries lesions" Teeth: permanent Sealants: not reported Restorations: excluded Surface: approximal |
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Patient characteristics and setting | Age: not reported Sex: not reported Ethnicity: not reported Country: Germany Setting: extracted teeth Number of participants/teeth/sites: 53 teeth, 106 teeth Prevalence: enamel 0.36, dentine 0.16 |
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Index tests | Category of test: 2 tests: NIR light ‐ DIAGNOcam, also near‐infrared light combined with high‐dynamic‐range imaging (NIR‐HDRI) Sequence of test(s): NIR and NIR‐HDRI, prior to reference standard Examiner training and calibration: "2 experienced examiners ..... were given a practical and theoretical training session", examiner assessments completed independently and repeated after 2 weeks Threshold applied: no decay, enamel, enamel with single point of contact to dentino‐enamel junction, enamel with extensive contact to dentino‐enamel junction, dentine Device specifics:
Note ‐ applicability is "high concern" as techniques used in paper are specifically designed scenarios established in an in vitro setting which are not currently available for a clinical setting |
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Target condition and reference standard(s) | Category: microCT Sequence of index test and reference standard: reference standard followed index test assessments Training of examiner: unclear; "Measurements were taken 3 times by one examiner, and the mean values calculated" Blinding to index test: unclear Multiple tests: no Site selection: extracted tooth microCT scan Target condition: radiolucency in the outer, or the inner half of the enamel, and radiolucency in the 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? | 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 tests) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
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? | Unclear risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | High | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
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? | Unclear 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 |