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. 2017 Apr 21;2017(4):CD012645. doi: 10.1002/14651858.CD012645

Rau 1998.

Study characteristics
Patient sampling Type of study: prospective study.
 Consecutive or random sample: unclear.
Patient characteristics and setting Sample size: 70.
 Females: 31 (44.3%).
 Age: 49 years.
 Presentation:
 Participants with acute pancreatitis (within fewer than 4 days of onset of symptoms).
 Setting: secondary care setting, Germany.
Index tests Index test: C‐reactive protein (day 3).
 Further details:
 Technical specifications: laser nephelometry.
 Performed by: not stated.
 Criteria for positive diagnosis: > 140 mg/L.
Index test: lactate dehydrogenase (day 5).
 Further details:
 Technical specifications: enzyme kinetic method.
 Performed by: not stated.
 Criteria for positive diagnosis: > 290 U/L.
Target condition and reference standard(s) Target condition: pancreatic necrosis.
 Reference standard: CT scan or intra‐operative findings, or both.
 Further details:
 Technical specifications: CT scan: CT 9800 (General Electric) and CT Twin Flash (Elscint); Surgery: not applicable.
 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: 0 (0%).
 Number of participants who were excluded from the analysis: not stated.
Comparative  
Notes This study reported 2 index tests.
Authors provided additional information that the index tests were interpreted without knowledge of reference standards. The authors also stated that the interval between the index tests and CT scan was 2 to 6 days, and the interval between index tests and laparotomy was 18 days.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
    Unclear Unclear
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? No    
    High 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    
    High 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? No    
Were all patients included in the analysis? Unclear    
    High  

CT: computed tomography