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. 2014 Oct 1;2014(10):CD008760. doi: 10.1002/14651858.CD008760.pub2

Schreibman 2011.

Study characteristics
Patient sampling Cross‐sectional cohort (screening cohort + surveillance cohort); prospective single‐centre study.
Patient characteristics and setting Participants: 37 participants (18 screening, 19 surveillance); 28 male, mean age 56 years (range 21 to 78 years)
Baseline diagnosis: aetiology: 11 alcohol; 8 non‐alcoholic steatohepatitis; 7 HCV; 5 alcohol + HCV; 6 other
Disease severity: Child‐Pugh score A 23; Child‐Pugh score B 9; Child‐Pugh score C 5.
Co‐morbidity: not available.
Geographical location of the study: USA.
Inclusion criteria: men aged > 18 years, or women aged > 18 years with a negative pre‐procedure pregnancy test or of non‐reproductive potential; inpatient or outpatient; able to provide informed consent.
Exclusion criteria: pregnancy; presence of a known Zenker's diverticulum; swallowing disorder; known intestinal diverticulum; suspected intestinal obstruction or stricture; pseudo‐obstruction; active variceal bleeding; presence of a cardiac pacemaker or implanted electro‐medical device; suspected or known Crohn's disease, presence of ileostomy.
Index tests Index test: capsule endoscopy (PillCam ESO)
Criteria for oesophageal varices: according to the North Italian Endoscopic Club (NIEC 1988).
Operator: blinded investigator and assessed using the same criteria.
Target condition and reference standard(s) Target condition: any and large oesophageal varices.
Reference standard: oesophago‐gastro‐duodenoscopy.
Criteria for oesophageal varices: as defined by the New Italian Endoscopic Club (NIEC 1988).
Prevalence of the target condition: 91% (31/34 participants).
Flow and timing Uninterpretable results: 3 cases not included in the analysis (in 2 participants, no capsule results were obtained due to capsule malfunction and inappropriate connection of the transmitter. In 1 participant, the capsule did not remain in the oesophagus long enough to provide adequate images).
Comparative  
Notes Observer variation: no data on observer variation were reported.
Uninterpretable results: 3 cases not included in the analysis.
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? No    
    High 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? Yes    
    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? No    
    High