Novaes 2012.

Study characteristics
Patient Sampling	Method of sampling: randomly selected, although precise methods are unclear, "randomly selected using the enrolment or history form of each child" Included conditions: no cavitation and early lesions Teeth: primary molars ‐ first and second present Sealants: unclear Surface: approximal
Patient characteristics and setting	Age: 4 to 12 years, mean 7.4 Sex: 32 male, 44 female Ethnicity: not reported Country: Sao Paulo, Brazil Setting: dental hospital, "children seeking dental treatment" suggests there will be some caries Number of participants/teeth/sites: 76 participants/344 approximal "spaces"/520 surfaces Prevalence: enamel 0.8
Index tests	Category of test: DIAGNOdent pen Sequence of test(s): index tests (visual, radiograph, DIAGNOdent pen) then reference standard Examiner training and calibration: trained but no calibration Teeth cleaning prior to examination: not reported Tooth drying prior to examination: not reported Threshold applied: calculated within study; 0–5 sound; 6+ cavitation Device specifics: tip A
Target condition and reference standard(s)	Category: visual ‐ separators Sequence of index test and reference standard: index tests then reference standard Training of examiner: yes Blinding to index test: unclear Multiple tests: no Site selection: approximal surface Target condition: sound and caries (including: white spot, cavitation)
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: 1 week to allow for separation of teeth Participants receiving both tests but excluded from results: 0
Comparative
Notes	Not possible to use data, 2x2 table not possible to construct since the outcome of interest was the affect of spacing on index test
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
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)?	Unclear
Could the conduct or interpretation of the index test have introduced bias?		Unclear 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)?	Unclear
Could the conduct or interpretation of the index test have introduced bias?		Unclear 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?			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?	Yes
Could the patient flow have introduced bias?		Low risk