Fujii1995.

Study characteristics
Patient Sampling	During the two years, from January 1989 to December 1990, 50 patients with hepatocellular carcinoma plus liver cirrhosis (37 males and 13 females) and 50 patients with liver cirrhosis alone (37 males and 13 females) were included. Age range not reported. Males 74%
Patient characteristics and setting
Index tests	The serum AFP was measured using an a‐Fetoprotein Radioimmunoassay Kit (Dinabot Laboratories, Tokyo, Japan), and its normal level is less than 20 ng/mL.
Target condition and reference standard(s)	In 37 out of the 50 hepatocellular carcinoma patients, diagnosis was made by histological examination (biopsy and necropsy); in the remainder, it was based on markedly elevated serum AFP levels (400 ng/mL), space‐occupied lesions demonstrable by various imaging techniques, and typical computed tomographic and/or angiographic findings [7‐10]. In the group of patients with liver cirrhosis, the diagnosis was made on liver biopsy in 40 patients, and on clinical, biochemical, and computed tomographical findings in the remaining 10 patients.
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?	No
If a threshold was used, was it pre‐specified?	Yes
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?	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