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. 2015 Feb 26;2015(2):CD010339. doi: 10.1002/14651858.CD010339.pub2

Katz 2004.

Study characteristics
Patient sampling Type of study: prospective study.
 Consecutive or random sample: consecutive participants.
Patient characteristics and setting Sample size: 41.
Females: not stated.
Age: not stated.
Presentation:
Inclusion criteria:
  1. People with suspicion of biliary stone disease on the basis of dilated common bile duct > 10 mm, abnormal liver function tests, or pancreatitis.


Setting: Department of Surgery, USA.
Index tests Index test: endoscopic retrograde cholangiography.
 Further details:
 Technical specifications: not stated.
 Performed by: endoscopist.
 Criteria for positive diagnosis: not stated.
Target condition and reference standard(s) Target condition: common bile duct stones.
 Reference standard: endoscopic extraction of bile duct stones in people with positive endoscopic retrograde cholangiography and follow‐up for at least 1 year for people with negative endoscopic retrograde cholangiography.
 Further details:
 Technical specifications: not applicable.
 Performed by: endoscopists and surgeons.
 Criteria for positive diagnosis: presence of stones during endoscopic clearance and clinical follow‐up with negative endoscopic retrograde cholangiography.
Flow and timing Number of indeterminates for whom the results of reference standard was available: not stated.
 Number of participants who were excluded from the analysis: not stated.
Comparative  
Notes Attempted to contact the authors in June 2013. Received no replies.
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    
    Low Low
DOMAIN 2: Index Test ERCP
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
    High High
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    
    High High
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Did all patients receive the same reference standard? No    
Were all patients included in the analysis? Yes    
    High