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. 2017 Apr 21;2017(4):CD012010. doi: 10.1002/14651858.CD012010.pub2

Abraham 2011.

Study characteristics
Patient sampling Type of study: prospective study.
 Consecutive or random sample: consecutive patients.
Patient characteristics and setting Sample size: 124.
 Females: not stated.
 Median or median age: not stated.
 Presentation:
 Patients with acute abdominal pain.
 Setting: secondary care, India.
Index tests Index test: serum amylase.
 Further details:
 Technical specifications: not stated.
 Performed by: not stated.
 Criteria for positive diagnosis: > 3 times normal.
Index test: serum lipase.
 Further details:
 Technical specifications: not stated.
 Performed by: not stated.
 Criteria for positive diagnosis: > 3 times normal.
Index test: urinary trypsinogen‐2.
 Further details:
 Technical specifications: Actim Pancreatitis (Medix Biochemica).
 Performed by: not stated.
 Criteria for positive diagnosis: > 50 ng/mL.
Target condition and reference standard(s) Target condition: acute pancreatitis.
 Reference standard: consensus definition.
 Further details:
 Technical specifications: not applicable.
 Performed by: not stated.
 Criteria for positive diagnosis: consensus definition.
For the index tests serum amylase and serum lipase, the answer for the signalling question 'Is the reference standard independent of the index test?' is 'No' and the risk of bias is 'High risk'.
Flow and timing Number of indeterminates for whom the results of reference standard were available: not stated.
 Number of patients who were excluded from the analysis: not stated.
Comparative  
Notes The index tests serum amylase and lipase were not independent of the reference standard, but urinary trypsinogen‐2 was independent of the reference standard.
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 Serum amylase
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    
    Unclear Low
DOMAIN 2: Index Test Serum Lipase
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    
    Unclear Low
DOMAIN 2: Index Test Urinary trypsinogen‐2 (standard criteria)
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    
    Unclear 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    
Is the reference standard independent of the index test? Yes    
    Unclear Low
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? Yes    
Were all patients included in the analysis? Yes    
Did all patients receive a reference standard? Yes    
    Unclear