| Study characteristics |
| Patient Sampling |
133 participants were enrolled in our study and were divided into three groups: HCC (n = 40), cirrhosis (n = 54), and control (n = 39). Patients with another malignancy were excluded from the study.
Age range: 45‐87. Males 73% |
| Patient characteristics and setting |
|
| Index tests |
AFP was measured by the chemiluminescence method (ARCHITECH system; Abbott Laboratories, Abbott Park; IL, USA). The upper limit of the normal level is 7 ng/mL. |
| Target condition and reference standard(s) |
The diagnosis of 22 HCC patients was made by histopathology. If histopathology was not present, the diagnosis of HCC was based on the American Association for the Study of Liver Diseases (AASLD) practice guidelines (11), and it was confirmed by imaging modalities (ultrasound, magnetic resonance imaging, or computed tomography) and biochemistry (AFP and liver function test). |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
Conflict of Interest: no conflict of interest was declared by the authors.
Financial disclosure: the authors declared that this study was funded by Scientific Research Projects Office of Gazi University. |
| 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? |
|
|
High |
| DOMAIN 2: Index Test (AFP) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
|
|
| 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? |
|
|
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 |
|
