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. |
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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'. |
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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 |