Van Hilsen 2013.
Study characteristics | |||
Patient Sampling | Method of sampling: selected, "A single examiner sorted through collected teeth and chose an assortment of teeth without evidence of cavitated lesions (ICDAS‐II 0–2)" Included conditions: no cavitation and early lesions Teeth: permanent premolars/molars Sealants: excluded Surface: occlusal |
||
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 (3 damaged) Prevalence: enamel 0.76, dentine 0.31 |
||
Index tests | Category of test: Midwest Sequence of test(s): index tests (visual using digital images, fluorescence, OCT) then reference standard Examiner training and calibration: yes, "two examiners (E1, E2) were trained to use the Midwest Caries ID™ (MID) according to the manufacturer’s directions" Teeth cleaning prior to examination: yes, "cleaned with pumice slurry to simulate a 'prophy cup' cleaning prior to assessment and copiously washed with water" Tooth drying prior to examination: "Teeth were kept moist" Threshold applied: sound = green/no beep, enamel = red/low frequency beep, dentine = red/high frequency beep Device specifics: "The tip of the device was inserted vertically on the surface of each tooth and moved around slightly (without pressure) in the pits and fissure area" |
||
Target condition and reference standard(s) | Category: histology Sequence of index test and reference standard: index test before reference standard Training of examiner: not reported Blinding to index test: yes Multiple tests: no Site selection: sectioned teeth Target condition: sound, enamel, dentine |
||
Flow and timing | Participants with index test but no reference standard: 3 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? | 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? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
If multiple tests were applied were different examiners used for each (in vivo)? | Yes | ||
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 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? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
If multiple tests were applied were different examiners used for each (in vivo)? | Yes | ||
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 |