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. |
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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. |
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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: as defined by the New Italian Endoscopic Club (NIEC 1988). Prevalence of the target condition: 91% (31/34 participants). |
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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. |
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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? | 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 |