| Study characteristics |
| Patient Sampling |
In this study, a total of 443 serum samples including 180 patients with HCC, 61 patients with liver cirrhosis (LC), 99 patients with chronic hepatitis, and 103 healthy individuals were enrolled from November 2011 to April 2013. |
| Patient characteristics and setting |
|
| Index tests |
Tumor markers (AFP, carcino‐embryonic antigen [CEA], carbohydrate antigen 19‐9 [CA19‐9]), and liver function parameters (total protein [TP], serum total bilirubin [STB], alanine aminotransferase [ALT], and aspartate aminotransferase [AST]) were tested using commercially available electrochemiluminescence immunoassay (Roche Diagnostics Ltd., Shanghai, China) |
| Target condition and reference standard(s) |
The HCC diagnosis was based on histopathology, and if histopathology was not available, it was performed on two imaging modalities (magnetic resonance imaging, computed tomography, or contrast enhanced ultrasound). |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
No conflicts of interest declared |
| 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? |
Yes |
|
|
| 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? |
|
|
Low concern |
| 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? |
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 |
|
