Mialhe 2003.

Study characteristics
Patient Sampling	Method of sampling: unclear Included conditions: unclear; "low caries prevalence (DMFT = 1.4)" Teeth: permanent premolars and molars Sealants: not reported Restorations: excluded Surface: approximal Note: "surfaces considered sound by all methods were excluded from the study sample"
Patient characteristics and setting	Age: 13 to 15 years Sex: not reported Ethnicity: not reported Country: Brazil Setting: school‐based recruitment Number of participants/teeth/sites: 70 participants, 199 teeth (in the final sample) Prevalence: enamel (no‐cavitation) 0.86; dentine (cavitation) 0.14
Index tests	Category of test: FOTI Sequence of test(s): index tests (visual, radiograph then FOTI) performed prior to reference standard Examiner training and calibration: 1 examiner for each test (visual, radiograph and FOTI) Threshold applied: no shadow, restricted to enamel, reaching dentine Device specifics: "FOTI (Fiber‐LiteÒ PL 800 series (Dolan‐Jenner Industries, Lawrence, MA, USA)) and a 0.5‐mm‐diameter probe"
Target condition and reference standard(s)	Category: visual after separation; "an orthodontic rubber ring (G & H Wire Company, Greenwood, IN) was placed with dental floss tied around the contact point of the teeth surfaces in which carious lesions had been detected. The rings were removed 24 h later and the surfaces were cleaned with dental floss and dried before examination" Sequence of index test and reference standard: reference standard followed index test Training of examiner: 3 examiners jointly decided Blinding to index test: unlikely Multiple tests: no Site selection: visual assessment of surface Target condition: sound no cavitation, cavitation
Flow and timing	Participants with index test but no reference standard: 1481 Participants with reference standard but no index test: 0 Time interval between tests: minimal Participants receiving both tests but excluded from results: 0 Note: 1481 of 1680 were excluded from analysis due to being sound
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?	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)?	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?	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?	No
Were all patients included in the analysis?	No
Could the patient flow have introduced bias?		High risk