Delavarian 2010.

Study characteristics
Patient sampling	Method of patient selection: Quote "study group consisted of 25 patients with 26 lesions which had been visited from Oct 2005 to Jan 2007, at Oral Medicine of Mashhad Faculty of Dentistry and Otorhinolaryngology Department of QAEM, IMAM, REZA and OMID hospitals, Mishhad, Iran." Quote "Inclusion criterion was: lesions clinically diagnosed as oral potentially malignant (leukoplakia, OLP) or malignant lesions (OSCC and verrucous carcinoma) and requiring an incisional biopsy for definite diagnosis."
Patient characteristics and setting	Age: 54.00 ± 17.38 Sex: 13 men 12 women SES: Not reported Ethnicity: Not reported Stated Risk Factors: unclear Number of patients/lesions: 25/26 Lesion site: Oral cavity Severity: quote "lesions clinically diagnosed as oral potentially malignant (leukoplakia, OLP) or malignant lesions (OSCC and verrucous carcinoma) and requiring incisional biopsy for definite diagnosis" Country: Iran Type of facility: Secondary Prevalance: (dysplasia /malignancy) 8/26 Exclusions: history of any treatment for the lesion, systemic contraindication for scalpel biopsy
Index tests	Category: Cytology ‐ OralCDx (lab processing not performed at OralCDx lab). Description: Quote "After determination of site biopsy, under local anaesthesia, needed for scalpel biopsy, the Oral CDx brush was placed in the selected area and turned 5 to 10 times until appearing pinpoint bleeding‐upon manufacture's recommendation." Positivity threshold: Quote "The pathological findings were categorized as three groups: 1) Positive: dysplastic epithelial changes 2) Negative: absence of any evidence suggesting dysplasia 3) Inadequate sampling" Sequence of tests: Index followed by reference Training or calibration of clinicians: Unclear. quote "They were examined by a pathologist informed about clinical diagnosis" Blinding of examiners: Index completed prior to reference, quote "blind to the histopathological results"" Multiple tests: No Method of site selection: Quote "The most impressive site of biopsy was determined upon one if these criteria: 1) The most probable site of dysplasia/malignancy OR 2) High risk area for dysplasia/malignancy OR 3) The most surgically accessible site" Conflict of interests: University support acknowledged.
Target condition and reference standard(s)	Category: Biopsy with histopathologic assessment Description: Scalpel biopsy method unclear. Positivity threshold: Quote "The Pindborg criteria for detecting dysplasia and malignancy were used and the histopathologic diagnosis was made. The presence of dysplasia/malignancy in histopathology was classified as normal , mild, moderate and severe dysplasia (level 1 to 3), carcinoma In Situ (level 4) and carcinoma (level 5)." Sequence of tests: index followed by reference Training or calibration of pathologists: unclear Blinding of examiners: Quote "The histopathologic preparations were observed by the same pathologist blind to the cytopathical study and informed about clinical diagnosis" Multiple tests: not applicable Method of site selection: Quote "The scalpel biopsy was done immediately in the site of pin‐point bleeding." Target condition: Quote "The Pindborg criteria for detecting dysplasia and malignancy were used and the histopathologic diagnosis was made. The presence of dysplasia/malignancy in histopathology was classified as normal , mild, moderate and severe dysplasia (level 1 to 3), carcinoma In Situ (level 4) and carcinoma (level 5).
Flow and timing	Patients receiving index test but not reference test: 0 Patients receiving reference test but not index test: 0 Time interval: Not discussed Patients receiving both index and reference test but excluded from analysis: 0
Comparative
Notes	Assumed figures in Table 2 should be reversed: "Gold Standard" Normal and Disease should be reversed. This has been done for data entry.
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?
		Low	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?	Yes
		Unclear	Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Unclear
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
		Unclear