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

El‐Sherif 2012.

Study characteristics
Patient Sampling The present study was carried on 80 participants. Patients with either liver cirrhosis or HCC were selected among patients who were admitted in the Department of Tropical Medicine and Gastroenterology and Internal medicine; Assiut University Hospital from September 2009 ‐ September 2010. They were 30 people with liver cirrhosis (group I) and 30 people with HCC (group II).
Age range not reported. Males 70%
Patient characteristics and setting  
Index tests Alpha‐foetoprotein was performed on IMMULITE analyser, using chemiluminescent assay (Siemens Healthcare Diagnostics, UK) with no predefined cut‐off value.
Target condition and reference standard(s) The diagnosis of HCC was ascertained using a histopathologic examination by liver needle biopsy (30 adults were enrolled in the present study; the patients underwent liver needle biopsy under ultrasound guidance). The diagnosis of cirrhosis was confirmed by abdominal ultrasonography and biochemical findings.
Flow and timing No information on interval between index test and reference standard
Comparative  
Notes No information on funding or 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? No    
Did the study avoid inappropriate exclusions? Unclear    
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? No    
Could the conduct or interpretation of the index test have introduced bias?   High 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? 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?     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