Lapalus 2009.
Study characteristics | |||
Patient sampling | Cross‐sectional cohort (only screening cohort); prospective 9‐centre study. Included inpatients and outpatients. | ||
Patient characteristics and setting |
Participants: 120 participants. Mean age 58 years, range 23 to 84 years. 72 (60%) men. However, only 113 participants were analysed (participants who had PillCam ESO). Baseline diagnosis: cirrhosis. Aetiology: 17 HCV, 78 alcohol, 14 non‐alcoholic steatohepatitis, 9 other causes. Disease severity: Child‐Pugh score A 48%, Child‐Pugh score B 30%, Child‐Pugh score C 22%. Mean Child‐Pugh score 7.4. Mean MELD score 11.5. Portal hypertension was related to cirrhosis in 113 participants. Co‐morbidity: not available. Geographical location of the study: France. Inclusion criteria: people with recently diagnosed cirrhosis. Exclusion criteria: aged < 18 years, pregnant, people with known or suspected gastrointestinal obstruction or strictures, people with cardiac pacemaker or other implanted electro‐medical devices, people with swallowing disorders or dysphagia, people with previous endoscopic or surgical oesophageal treatment. Representative spectrum? Yes. "Recently diagnosed cirrhosis" and aetiology of liver diseases were described. "All the patients had their procedure performed for screening purpose." |
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Index tests |
Index test: capsule endoscopy (PillCam ESO). Criteria for oesophageal varices: other classification, adequately described and logically defined. Operator: 2 independent experienced endoscopists. Blinded from the reference standard. |
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Target condition and reference standard(s) |
Target condition: any and large oesophageal varices. Reference standard: oesophago‐gastro‐duodenoscopy. Criteria for oesophageal varices: other classification, adequately described and logically defined. Prevalence of the target condition: 63% (71/113 participants). |
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Flow and timing | Capsule endoscopy procedure was feasible in 113/120 (94%) participants. 7 people were not included in the analysis due to uninterpretable results. | ||
Comparative | |||
Notes |
Observer variation: data on observer variation were reported. Kappa for detection of varices = 0.582 in only 107 participants (lost for 6 participants). Uninterpretable results: data were reported. Side effects or complications: no severe side effects or complications were observed. 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? | 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? | No | ||
Were all patients included in the analysis? | Yes | ||
High |