Ramirez 2005.
Study characteristics | |||
Patient sampling | Cross‐sectional cohort (screening cohort + surveillance cohort); prospective single‐centre study. | ||
Patient characteristics and setting |
Participants: 30 participants (11 for screening, 19 for surveillance). Mean age 54.4 years, range 43 to 69 years. 30 (100%) men. Outpatients only. Baseline diagnosis: cirrhosis. Aetiology: 14 HCV, 8 alcohol, 7 alcohol + HCV; 1 cryptogenic. Disease severity: mean MELD score 12.5; mean Child‐Pugh score 6.3. Co‐morbidity: not available. Geographical location of the study: USA. Inclusion criteria: cirrhosis. People scheduled for oesophago‐gastro‐duodenoscopy for screening or surveillance of oesophageal varice. Exclusion criteria: not available. |
||
Index tests |
Index test: string wireless capsule endoscopy (device was modified attaching a string to control movement up and down the oesophagus). Criteria for oesophageal varices: other classification, adequately described and logically defined. Operator: 1 experienced endoscopist, but no information about experience with index test. Blinded from the reference standard. |
||
Target condition and reference standard(s) |
Target condition: oesophageal varices. Reference standard: oesophago‐gastro‐duodenoscopy. Criteria for oesophageal varices: other classification, adequately described and logically defined. Prevalence of the target condition: 83% (25/30 participants). |
||
Flow and timing | Reference standard and index test timing: variable. 20 participants were at the same day, 3 within 24 hours, 2 within 14 days, 1 within 1 month, 4 after 1 month. | ||
Comparative | |||
Notes |
Observer variation: no data on observer variation were reported. Uninterpretable results: uninterpretable results were not reported. Side effects or complications: data on side effects or complications were reported. The string wireless capsule was deemed to be easy or mildly difficult to swallow by 79.3% (23/29) of participants, moderately difficult by 17.2% (5/29), very difficult by 3.5% (1/29). Pulling the string capsule out of the oesophagus caused no or minimal discomfort in 82.8% (24/29) and moderate discomfort in 17.2% (5/29). 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? | Unclear | ||
Low | Low | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | No | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
High |