| Study characteristics |
| Patient Sampling |
The estimation population consisted of patients from the Tropical Medicine Unit (Mansoura University Hospitals, Mansoura, Egypt). In this retrospective study, all patients had chronic hepatitis C. Participants were divided into two main groups: group I – HCC which included 227 cirrhotic patients with proved HCC. The non‐malignant chronic liver disease (CLD) group included 1124 patients with chronic hepatitis (836 males, 288 females). Patients with the following conditions were excluded from the study: presence of other causes of liver diseases, hepatitis B virus (HBV) infection, or other suspected malignancies.
Age range not reported. Males 77% |
| Patient characteristics and setting |
|
| Index tests |
AFP level was performed by chemiluminescence, with IMMULITE AFP (1000) kit (Diagnostic Products Corporation, Los Angeles, CA, USA). |
| Target condition and reference standard(s) |
The diagnosis of HCC in those patients was carried out according to the American Association for the Study of Liver Diseases (AASLD) Practice Guidelines (Bruix and Sherman, 2005). The diagnosis of HCC was based on AFP levels X400Ul1, presence of hepatic focal lesion (s) detected by liver ultrasound (US), and confirmed by computed tomography (CT) and/or magnetic resonance imaging (MRI) techniques. The final diagnosis was confirmed by histopathologic analysis on US‐assisted fine‐needle biopsy, when indicated. Diagnosis of CLD in this group was based on the standard clinical, biochemical, and ultrasonographic criteria, as well as the pathological data. |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
Authors declared 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? |
No |
|
|
| 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 |
|
