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

Villacastin Ruiz 2016.

Study characteristics
Patient Sampling "From November 2001 to December 2011, 323 orthotopic LTs were performed on 313 patients at our centre. Our study is based on the retrospective analysis of data from 273 patients (213 men and 60 women), of an average age of 55 years (31–79), who underwent scheduled transplants because of cirrhosis. Exclusion criteria were as follows: having undergone urgent non elective transplants; having undergone retransplantation; and absence of cirrhosis. Ultrasonography was carried out in 270 patients."
Age range: 31‐79. Males 78%
Patient characteristics and setting  
Index tests Abdominal ultrasonography was performed using a Toshiba SSA‐340 (Toshiba Corporation, Tokyo, Japan) (November 2001 to May 2009) and a Toshiba Aplio XG (Toshiba Corporation) (June 2009 to December 2011) equipped with a 3.5 MHz curved array transducer. We retrospectively revised all of the pretransplant reports carried out by experienced radiologists for each imaging study. A negative result (no HCC) was recorded when no lesion was detected or when the lesions were benign. Studies registered as positive were those in which a lesion suggesting HCC was observed.
Target condition and reference standard(s) "The pathological analysis of the explant livers provided our reference standard. The reports were reviewed retrospectively, and the presence, size and location of HCC nodules were recorded.
Correlation of nodules between the image and pathological results was based primarily on location and secondarily on size."
Flow and timing The average waiting time between imaging tests and transplant was 105 days.
Comparative  
Notes No conflicts of interest declared
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? No    
Could the selection of patients have introduced bias?   High risk  
Are there concerns that the included patients and setting do not match the review question?     High
DOMAIN 2: Index Test (AFP)
DOMAIN 2: Index Test (US+AFP)
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? No    
Could the reference standard, its conduct, or its interpretation have introduced bias?   High 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? Yes    
Could the patient flow have introduced bias?   High risk