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% |
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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 |