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

Chang 2011.

Study characteristics
Patient sampling Type of study: retrospective study.
 Consecutive or random sample: neither.
Patient characteristics and setting Sample size: 3451.
 Females: not stated.
 Median or median age: not stated.
 Presentation:
 Patients with acute abdominal pain and undergoing blood tests.
 Exclusion criteria
 Patients with parotid disease, intracranial haemorrhage, end‐stage renal failure.
 Setting: secondary care, Hong Kong, China.
Index tests Index test: serum amylase.
 Further details:
 Technical specifications: Beckman Coulter chemistry analyser.
 Performed by: not stated.
 Criteria for positive diagnosis: > 3 times normal.
Second criteria for positive diagnosis: > twice normal.
Index test: serum lipase.
 Further details:
 Technical specifications: Beckman Coulter chemistry analyser.
 Performed by: not stated.
 Criteria for positive diagnosis: > 3 times normal.
Second criteria for positive diagnosis: > twice normal.
Target condition and reference standard(s) Target condition: acute pancreatitis.
 Reference standard: radiology (ultrasound or CT).
 Further details:
 Technical specifications: not stated.
 Performed by: not stated.
 Criteria for positive diagnosis: not stated.
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  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? No    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? No    
    High High
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? Unclear    
    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? Unclear    
    Unclear Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
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    
    High 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? Unclear    
Did all patients receive a reference standard? Yes    
    Unclear