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

Burkitt 1987.

Study characteristics
Patient sampling Type of study: prospective study.
 Consecutive or random sample: neither.
Patient characteristics and setting Sample size: 306.
 Females: not stated.
 Median or median age: not stated.
 Presentation:
 People with abdominal pain.
Note: 88 patients who had normal urinary amylase were excluded from analysis.
 Setting: seconday care, UK.
Index tests Index test: urinary amylase.
 Further details:
 Technical specifications: Rapignost‐Amylase test.
 Performed by: not stated.
 Criteria for positive diagnosis: 1 plus.
Second criteria for positive diagnosis: 2 plus.
Target condition and reference standard(s) Target condition: acute pancreatitis.
 Reference standard: Phadebas Amylase > 1000 (normal limit 300) + abdominal pain.
 Further details:
 Technical specifications: not stated.
 Performed by: not stated.
 Criteria for positive diagnosis: amylase > 1000 (normal limit 300) + abdominal pain.
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: 88 (28.8%).
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? Unclear    
    High High
DOMAIN 2: Index Test Urinary 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 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? Yes    
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