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

Alsebaey 2016.

Study characteristics
Patient Sampling Eighty‐seven people were enrolled into the study. Twenty‐two healthy people as a control group (n = 22), 22 patients in the cirrhosis group and finally 43 patients in the HCC group. The diagnosis of cirrhosis was based on clinical, laboratory, and ultrasonography findings (Schuppan and Afdhal, 2008). HCC was diagnosed according to the EASL guideline (European Association for the Study of the et al.). Exclusion criteria were sepsis, GIT bleeding, concurrent medical disease such as long standing diabetes mellitus, chest or cardiac disease.
Age range and % of males not reported
Patient characteristics and setting  
Index tests AFP no specification
Target condition and reference standard(s) HCC CT and EASL criteria; controls ultrasound
Flow and timing No information on interval between index test and reference standard
Comparative  
Notes No information on conflicts of interest or funding
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? Unclear    
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? Unclear    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   High risk