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. 2021 Apr 15;2021(4):CD013346. doi: 10.1002/14651858.CD013346.pub2

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%
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