Silverstein 1998.
Study characteristics | |||
Patient sampling | Type of study: prospective. Consecutive or random sample: consecutive. | ||
Patient characteristics and setting | Sample size: 262. Females: 206 (78.6%). Age: 47 years. Presentation: Inclusion criteria:
Setting: Department of Surgery, USA. |
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Index tests | Index test: ultrasound.
Technical specifications: not stated.
Performed by: not stated.
Criteria for positive diagnosis: common bile duct diameter > 6 mm. Index test: bilirubin. Technical specifications: not applicable. Performed by: not applicable. Criteria for positive diagnosis: cut‐offs used to define test positivity were > 22.23 μmol/L and > twice the normal limit. Index test: alkaline phosphatase. Technical specifications: not applicable. Performed by: not applicable. Criteria for positive diagnosis: cut‐offs used to define test positivity were > 125 IU/L and > twice the normal limit. |
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Target condition and reference standard(s) | Target condition: common bile duct stones. Reference standard: endoscopic or surgical extraction of stones in people with positive intraoperative cholangiogram and clinical follow‐up of minimum 2 years in other people (participants underwent selective cholangiogram). Technical specifications: not applicable. Performed by: endoscopists, surgeons, and clinicians. Criteria for positive diagnosis: endoscopic or surgical extraction of stones in people with positive intraoperative cholangiogram and clinical follow‐up of minimum 2 years in other people (participants underwent selective cholangiogram). | ||
Flow and timing | Number of indeterminates for whom the results of reference standard was available: not stated. Number of participants who were excluded from the analysis: not stated. | ||
Comparative | |||
Notes | Attempted to contact the authors in June 2013. Received no replies. | ||
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 All tests | |||
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 | ||
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 | ||
High | High | ||
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? | No | ||
Were all patients included in the analysis? | Yes | ||
High |