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. 2021 Jan 27;2021(1):CD013855. doi: 10.1002/14651858.CD013855

Holt 1989.

Study characteristics
Patient Sampling Method of sampling: not reported
Included conditions: not reported; "bitewing radiographs were indicated"
Teeth: primary canines and molars
Sealants: not reported
Restorations: not reported
Surface: approximal
Patient characteristics and setting Age: 5 to 10 years
Sex: not reported
Ethnicity: not reported
Country: UK
Setting: community dental clinic
Number of participants/teeth/sites: 54 participants, 781 surfaces
Prevalence: enamel 0.08
Index tests Category of test: FOTI
Sequence of test(s): index tests prior to reference standard
Examiner training and calibration: not reported ‐ examiners viewed independently
Threshold applied: sound, any caries
Device specifics: "150H universal light source, housing a 150 watt tungsten bulb, a 2 mm diameter fibre optic cable and a fibre optic probe tip of 0.5 mm diameter"
Target condition and reference standard(s) Category: radiographs
Sequence of index test and reference standard: reference standard completed prior to transillumination
Training of examiner: not reported
Blinding to index test: yes ‐ completed after index test
Site selection: all approximal surfaces
Target condition: sound, enamel, or dentine
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: 209 deemed unreadable by radiograph
Comparative  
Notes Examiner 1 results used for data analysis
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
Could the selection of patients have introduced bias?   Unclear risk  
Are there concerns that the included patients and setting do not match the review question?     Low concern
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)?      
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? No    
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?   High risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     High
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?   High risk