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

Ziada 2016.

Study characteristics
Patient Sampling This is a cross‐sectional study which prospectively included all adult patients with chronic HCV from the outpatient clinics and inpatient wards of Tropical Medicine and Infectious Diseases Department at Tanta University Hospital, Tanta, Egypt.
103 patients were confirmed to have HCC, and 411 had no HCC.
Exclusion criteria: patients with diagnosed HCC, hepatic metastasis, and prior HCC treated lesions
Age range: 29‐78. Males 81%
Patient characteristics and setting  
Index tests AFP: cut‐off values were predefined at 100 ng/mL and 200 ng/mL
Target condition and reference standard(s) All cases were screened for HCC using ultrasonography and AFP. Individuals with solid focal lesion in ultrasound examination, and/or serum AFP level > 200 ng/mL were examined by tri‐phasic CT, and/or MRI to confirm or roll out the diagnosis of HCC.
Flow and timing No information on interval between index test and reference standard
Comparative  
Notes "Authors declare no 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? No    
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)
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)
DOMAIN 2: Index Test (US)
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?     Low concern
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    
Could the patient flow have introduced bias?   High risk