Van Hilsen 2013.
Study characteristics | |||
Patient Sampling | Method of sampling: selected Included conditions: sound and non‐cavitated; "A single examiner sorted through collected teeth and chose an assortment of teeth without evidence of cavitated lesions (ICDAS‐II 0–2)" Teeth: permanent posterior teeth Sealants: excluded Restorations: excluded Surface: occlusal |
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Patient characteristics and setting | Age: not reported Sex: not reported Ethnicity: not reported Country: USA Setting: extracted teeth Number of participants/teeth/sites: 45 teeth/sites Prevalence: enamel 0.76, dentine 0.31 |
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Index tests | Category of test: CP‐OCT; "CP‐OCT images were presented to two blinded examiners who had at least 4 months experience assessing CP‐OCT images of sound, non‐cavitated, and cavitated lesions. Examiners (E5, E6) independently graded the images" Sequence of test(s): MidWest caries, visual, photographic, OCT prior to reference standard ‐ all blinded with different assessors Examiner training and calibration: 2 blinded examiners with at least 4 months experience of OCT Threshold applied: sound, incipient subsurface (enamel), extensive subsurface (dentine) Device specifics: "cross‐polarization swept source OCT (CP‐OCT) system with an intraoral probe (IVS‐200‐CPM, Santec Co Komaki, Japan)" |
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Target condition and reference standard(s) | Category: histology Sequence of index test and reference standard: index test then reference standard Training of examiner: not reported Blinding to index test: yes Multiple tests: no Site selection: sectioned teeth Target condition: sound, enamel, dentine |
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Flow and timing | Participants with index test but no reference standard: 3 damaged during sectioning of tooth 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? | Low 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? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low 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? | Low risk |