Gambarin‐Gelwan 2000.
Study characteristics | |||
Patient Sampling | This study 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 participants had US, CT, and serum AFP measurements within 6 months of OLT. The results were compared to explant histology. Pathological analysis of 106 explants revealed HCC in 19 participants. | ||
Patient characteristics and setting | Only patients who underwent OLT were analysed. | ||
Index tests | CT: All participants underwent conventional CT scans, performed on a GE 9800 CT scanner (General Electric, Milwaukee, WI). Serial transaxial scans were obtained from the diaphragm to the iliac crests by 10 mm collimation sections. Scans were obtained during suspended respiration after administration of oral contrast (E‐Z‐CAT, E‐Z‐M, Inc., Westbury, NY), as well as 150 mL of IV contrast (Omnipaque 240, Sterling Pharmaceuticals, Inc., Barceloneta, Puerto Rico). Radiological examinations were performed by radiologists specialising in the hepatobiliary system. A physician who was blinded to pathology results reviewed US and CT reports. Reports were given a semiquantitative score of 1–4, based upon level of suspicion for HCC |
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Target condition and reference standard(s) | HCC. 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 | The time interval is < 180 days, therefore some participants had interval > 90 days. | ||
Comparative | |||
Notes | No information on CoI | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | 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 (All tests) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
Were positivity criteria clearly defined? | 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? | No | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis and analysed according to intention to diagnose principle (non‐evaluable results considered as false)? | Yes | ||
Could the patient flow have introduced bias? | High risk |