Mayumi 2012.
| Study characteristics | |||
| Patient sampling | Type of study: prospective study. Consecutive or random sample: consecutive patients. | ||
| Patient characteristics and setting | Sample size: 412. Females: 186 (45.1%). Median or median age: 55 years. Presentation: Adult patients with acute abdominal pain. Setting: secondary care, Japan. | ||
| Index tests | Index test: serum amylase.
Further details:
Technical specifications: BioMajesty JCA‐BM or LABOSPECT.
Performed by: study collaborators.
Criteria for positive diagnosis: > 3 times normal. Index test: serum lipase. Further details: Technical specifications: BioMajesty JCA‐BM or LABOSPECT. Performed by: study collaborators. Criteria for positive diagnosis: > 3 times normal. Index test: urinary trypsinogen‐2. Further details: Technical specifications: Actim Pancreatitis (Medix Biochemica). Performed by: study collaborators. Criteria for positive diagnosis: > 50 ng/mL. Second criteria for positive diagnosis: only + or most positive. Index test: urinary trypsinogen‐2. Further details: Technical specifications: quantitative immunoenzymometric assay trypsinogen‐2 test (Medix Biochemica). Performed by: study collaborators. 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 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 | 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? | Yes | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Low | Low | ||
| DOMAIN 2: Index Test Serum Lipase | |||
| 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? | Yes | ||
| Low | 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? | Yes | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Low | Low | ||
| DOMAIN 2: Index Test Urinary trypsinogen‐2 (non‐standard criteria) | |||
| 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? | 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? | Unclear | ||
| Did all patients receive a reference standard? | Yes | ||
| Unclear | |||