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. 2015 Feb 26;2015(2):CD011548. doi: 10.1002/14651858.CD011548

Silverstein 1998.

Study characteristics
Patient sampling Type of study: prospective.
 Consecutive or random sample: consecutive.
Patient characteristics and setting Sample size: 262.
Females: 206 (78.6%).
Age: 47 years.
Presentation:
Inclusion criteria:
  1. People undergoing cholecystectomy with ≥ 1 of the following features

  2. Abnormal liver function tests.

  3. History of obstructive jaundice or pancreatitis.

  4. Common bile duct diameter > 6 mm in calibre on ultrasound.


Setting: Department of Surgery, USA.
Index tests Index test: ultrasound.
 Technical specifications: not stated.
 Performed by: not stated.
 Criteria for positive diagnosis: common bile duct diameter > 6 mm.
Index test: bilirubin.
 Technical specifications: not applicable.
 Performed by: not applicable.
 Criteria for positive diagnosis: cut‐offs used to define test positivity were > 22.23 μmol/L and > twice the normal limit.
Index test: alkaline phosphatase.
 Technical specifications: not applicable.
 Performed by: not applicable.
 Criteria for positive diagnosis: cut‐offs used to define test positivity were > 125 IU/L and > twice the normal limit.
Target condition and reference standard(s) Target condition: common bile duct stones.
 Reference standard: endoscopic or surgical extraction of stones in people with positive intraoperative cholangiogram and clinical follow‐up of minimum 2 years in other people (participants underwent selective cholangiogram).
 Technical specifications: not applicable.
 Performed by: endoscopists, surgeons, and clinicians.
 Criteria for positive diagnosis: endoscopic or surgical extraction of stones in people with positive intraoperative cholangiogram and clinical follow‐up of minimum 2 years in other people (participants underwent selective cholangiogram).
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 All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
If a threshold was used, was it pre‐specified? Yes    
    High 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    
    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