Aoyama 2014.

Study characteristics
Patient sampling	Cross‐sectional cohort (only screening cohort); prospective single‐centre study.
Patient characteristics and setting	Participants: 119 participants; 73 men, 46 women; mean age 66.9 years, range 23 to 88 years. Baseline diagnosis: clinically or histologically confirmed cirrhosis. Aetiology: 18 HBV; 70 HCV; 13 alcohol; 6 non‐alcoholic steatohepatitis; 12 other. Disease severity: 56 participants were Child‐Pugh score A, 56 participants were Child‐Pugh score B, and 7 participants were Child‐Pugh score C. Co‐morbidity: not available. Geographic location of the study: Japan. Inclusion criteria: clinically or histologically confirmed cirrhosis with suspected bleeding from the small bowel or iron deficiency anaemia with a haemoglobin level of ≤ 12.0 g/dL, or both. Exclusion criteria: people with previous treatment for portal hypertension; previous bleeding.
Index tests	Index test: PillCam SB/SB2 video capsule (Given Imaging Ltd, Yokneam, Israel) a device planned for intestinal exploration not dedicated to the oesophagus. Criteria for oesophageal varices: oesophageal varices appearing as abnormally dilated longitudinal veins in the oesophagus. Operator: 2 interpreters, who were unaware of the participants' oesophago‐gastro‐duodenoscopy results, evaluated the images captured by capsule endoscopy for the presence or absence of oesophageal varices. Diagnoses were reached by consensus. The 2 interpreters had limited experience with oesophageal capsule endoscopy but much experience with capsule endoscopy (> 200 small‐bowel examinations) and oesophago‐gastro‐duodenoscopy (> 3000 examinations).
Target condition and reference standard(s)	Target condition: presence of any oesophageal varices. Reference standard: oesophago‐gastro‐duodenoscopy. Criteria for oesophageal varices: the Japanese endoscopic classification (JSPH 1980). Prevalence of the target condition: 43% (51/119).
Flow and timing
Comparative
Notes	Observer variation: no data on observer variation were reported. Uninterpretable results: no data on withdrawals were reported. Side effects or complications: no side effects or complications were described. Type of publication: full text.
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
Did the study enrol only patients with suspected oesophageal varices not until diagnosed?	Yes
		Low	Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
		Low	Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
		Low	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