Kim 2017.
Study characteristics | |||
Patient Sampling | Method of sampling: not clearly reported Included conditions: severity of condition unclear, "subjects with 1 or more proximal caries surfaces detected visually or radiographically were included in the study", restorations were included Teeth: permanent molars and premolars Sealants: not reported Surface: approximal |
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Patient characteristics and setting | Age: 19 to 60 years Sex: 55% male Ethnicity: not reported Country: South Korea Setting: extracted teeth Number of participants/teeth/sites: 65 teeth/280 sites Prevalence: enamel 0.61, dentine 0.20 |
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Index tests | Category of test: QLF‐Digital Biluminator 2+ (QLF‐D, Inspektor Research Systems BV, Amsterdam, The Netherlands), 2 methods one using QA2 software, the second using fluorescence images interpreted by an examiner: "Normal white‐light images and sequential fluorescence images were captured with a “live view” enabled full‐frame sensor digital SLR camera" Sequence of test(s): visual then radiograph followed by QLF, radiograph was the reference standard Examiner training and calibration: 1 trained examiner completed all index tests and reference standard Teeth cleaning prior to examination: full‐mouth scaling and polishing Tooth drying prior to examination: not reported Threshold applied: method used for fluorescence image method: shadow and no red fluorescence (Q0), an irregular dark shadow but no red fluorescence (Q1), faint red fluorescence limited to 1/3 of the buccolingual width (Q2), and strong red fluorescence over 1/3 of the buccolingual width (Q3) |
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Target condition and reference standard(s) | Category: radiograph Sequence of index test and reference standard: reference standard prior to index test Training of examiner: not reported, but experienced Blinding to index test: no Multiple tests: no Site selection: approximal surfaces Target condition: sound, outer/inner enamel, outer/inner dentine |
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Flow and timing | Participants with index test but no reference standard: 15 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 | Data used for the fluorescence images method as the 2x2 figures were not available for the software method | ||
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? | 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? | 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? | 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) | |||
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? | 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? | High risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (Blue fluorescence) | |||
DOMAIN 2: Index Test (Red fluorescence) | |||
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? | Yes | ||
Were all patients included in the analysis? | No | ||
Could the patient flow have introduced bias? | High risk |