Gambarin‐Gelwan 2000.
Study characteristics | |||
Patient Sampling | We analysed retrospectively the charts of 106 consecutive adult patients who underwent OLT for treatment of cirrhosis over a 1‐year period at Mount Sinai Hospital. All patients had US, CT, and serum AFP measurements within 6 months of OLT. The results were compared to explant histology. Age range: 24‐71. Males 65% |
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Patient characteristics and setting | |||
Index tests | QUOTE: "US: US exams were performed using an ATL UM‐9 (Advanced Technology Laboratories, Bothell, WA). Depending upon the patient’s physique, either a 2.25‐MHz or a 2‐ to 4‐MHz broad bandwidth transducer was used. AFP: AFP < 20 ng/mL, the upper limit of normal at our institution, was defined as low risk. AFP > 20 ng/mL was defined as high risk." | ||
Target condition and reference standard(s) | Explant histology: a pathologist specialising in the hepatobiliary system reviewed all liver explants. Each liver explant was sectioned every 1 cm. The presence of tumour nodules, their size, and their location were recorded. The underlying liver pathology was evaluated. | ||
Flow and timing | No information on interval between index test and reference standard | ||
Comparative | |||
Notes | No data on conflicts of interest | ||
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 | ||
Could the selection of patients have introduced bias? | Low risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
DOMAIN 2: Index Test (AFP) | |||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (US+AFP) | |||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (US) | |||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
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? | Yes | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | 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? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Unclear risk |