| Study characteristics |
| Patient Sampling |
A total of 535 patients with chronic hepatitis B (CHB), including 176 HCC patients and 359 CHB patients with other liver diseases, were retrospectively enrolled at the Affiliated Hospital of Northern Sichuan Medical College from January 2017 to March 2019. A total of 359 CHB patients, including 186 with cirrhosis, 53 with cholecystitis, 37 with bile duct stones, 21 with drug‐induced hepatitis, 51 with alcoholic hepatitis, 8 with hepatitis E.
infection, and 3 with hepatitis C infection.
Age range: 39‐62. Males 81% |
| Patient characteristics and setting |
|
| Index tests |
Serum levels of AFP were measured by electrochemiluminescence immunoassay.
No predefinition of a cut‐off value |
| Target condition and reference standard(s) |
The diagnosis of HCC was made in accordance with the standards of the guidelines for the diagnosis and treatment of primary HCC issued by the Chinese Society of Clinical Oncology.
Controls: no definition |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
"The authors have no conflicts of interest to declare." |
| 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? |
Yes |
|
|
| 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? |
|
|
High |
| DOMAIN 2: Index Test (US+AFP) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
|
|
|
| If a threshold was used, was it pre‐specified? |
|
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
|
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
|
| DOMAIN 2: Index Test (US) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
|
|
|
| If a threshold was used, was it pre‐specified? |
|
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
|
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
|
| DOMAIN 3: Reference Standard |
| Is the reference standards likely to correctly classify the target condition? |
No |
|
|
| 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? |
|
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 |
|
