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

Lapalus 2006.

Study characteristics
Patient sampling Cross‐sectional (only screening cohort); prospective cohort single‐centre study. Included both inpatients and outpatients.
Patient characteristics and setting Participants: 21 participants. Mean age 62 years, range 49 to 79 years. Sex: not available.
Baseline diagnosis: cirrhosis. Aetiology: 5 HCV infection, 15 alcohol, 2 autoimmune hepatitis, 1 non‐alcoholic steatohepatitis, 1 haemochromatosis.
Disease severity: Mean MELD score 10.5 and mean Child‐Pugh score 7.3. Child‐Pugh score A 62%; Child‐Pugh score B 28%; Child‐Pugh score C 10%.
Co‐morbidity: not available.
Geographical location of the study: France
Inclusion criteria: people with recently diagnosed cirrhosis.
Exclusion criteria: people aged < 18 years, pregnant, people with known or suspected gastrointestinal obstruction or strictures, people with a cardiac pacemaker or other implanted electro‐medical devices, people with swallowing disorders or dysphagia, people who had previously received endoscopic or surgical oesophageal treatment.
Index tests Index test: capsule endoscopy (PillCam ESO).
Criteria for oesophageal varices: conventional oesophago‐gastro‐duodenoscopy grading system.
Operator: 1 experienced capsule endoscopist, blinded from the reference standard.
Target condition and reference standard(s) Target condition: any oesophageal varices.
Reference standard: oesophago‐gastro‐duodenoscopy.
Criteria for oesophageal varices: not available.
Prevalence of the target condition: 80% (16/20 participants).
Flow and timing 1 participant was unable to swallow the capsule and was not included in the analysis.
Comparative  
Notes Observer variation: no data on observer variation were reported.
Uninterpretable results: data were reported.
Side effects or complications: data on side effects were reported. 10% of participants experienced difficulties in swallowing capsule endoscopy.
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? 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