Koch 2011b.

Study characteristics
Patient sampling	Method of patient selection: Quote "78 patients participating in the study attended the outpatient clinic of the Oral and Maxillofacial Surgery clinic of the Mainz University Medical Centre and suffered from suspicious oral mucosal lesions"
Patient characteristics and setting	Age: Mean 61.7 Sex: 59% male, 41% female SES: not reported Ethnicity: not reported Stated Risk Factors: not reported Number of patients/lesions: 78/78 Lesion site: Cheek 26, Gingival 22, Floor of the mouth 7, Sulcus glossoalv. 2, Tongue lower side 2, Tongue dorsum 3, Palate 8, Arcus palatogloss. 5, Inner lips 3 Severity: 41% red, like erythroplakia (17%) or erythroleukoplakia (24%); 21% white, like leukoplakia 21% ulcerous; 17%, a speckled, including fibrin‐covered lesions. Country: Germany Type of facility: University Medical Centre Prevalence: 33/78
Index tests	Category: Light based Description: Quote “Two different investigation methods were applied: the standard examination by white light and the examination by a 400‐nm wavelength light source that is supposed to trigger a green light emission (>500 mm) in normal mucosa.” Documented by digital reflex photography. Positivity threshold: SCC, and dysplasia [identified] depending on two different autofluorescence features: (1) A black or dark green aspect, as well as red indicating dysplasia or SCC (positive). Also, a speckled, heterotopic aspect of both green and autofluorescence negative or reddish regions indicated a positive finding. (2) The presence of red mucosal autofluorescence was evaluated as a separate indicator for dysplasia or SCC (positive). Sequence of tests: Index then reference Training or calibration of clinicians: Not clearly discussed Blinding of examiners: One experienced examiner performed the visual examination, two examiners examined the photographs, they were blinded and independent. Multiple tests: Visual then light, class as one index test only, as an adjunct. Method of site selection: Not discussed Conflict of interests: None
Target condition and reference standard(s)	Category: Biopsy with histopathologic assessment Description: quote “a biopsy by incision was performed. Then, the biopsies were fixed with formaldehyde 4.5% and processed for light microscopy via paraffin‐embedded, haematoxylin–eosin‐stained slices.” Positivity threshold: Mucosal hyperkeratosis, Lichen planus, SCC, Inflammation, Dysplasia, Healthy mucosa Sequence of tests: Index then Reference Training or calibration of pathologists: performed by one experienced examiner Blinding of examiners: not described Multiple tests: no Method of site selection: biopsy of photographed lesion Target condition: SCC and dysplasia
Flow and timing	Patients receiving index test but not reference test: 0 Patients receiving reference test but not index test: 0 Time interval: Biopsy taken immediately after index test. Patients receiving both index and reference test but excluded from analysis: 0
Comparative
Notes	Results calculated from sensitivity and specificity in table 2.
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Unclear
Did the study avoid inappropriate exclusions?	Unclear
		Unclear	Low
DOMAIN 2: Index Test Test group A
If a threshold was used, was it pre‐specified?	Yes
Were there any conflicts of interest? (if no information given at all then judge as unclear)	No
Was calibration of examiners undertaken and results reported?	Unclear
Where multiple index tests were used were the results of the second index test interpreted without knowledge of the first index test?
		Unclear	Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Unclear
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
		Unclear	Low
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
		Low