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. |
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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. |
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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). |
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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. |
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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 |