| Study characteristics |
| Patient Sampling |
60 HCV‐positive patients either attended or were admitted to the Department of Hepatology and Gastroenterology or Internal Medicine, Benha University Hospital, Egypt from October 2014 to March 2015. The study population was divided as follows.
Group I: 30 HCV‐positive patients with HCC, aged 32–64 years
Group II: 30 HCV‐positive patients with liver cirrhosis, aged 34–58 years.
Males 55% |
| Patient characteristics and setting |
|
| Index tests |
AFP levels (0.3–1000 ng/mL) were assessed by Axsym using microparticle enzyme immunoassay (MEIA) technology with no prespecified cut‐off value. |
| Target condition and reference standard(s) |
We used triphasic CT, and/or MRI to detect characteristic focal lesions of HCC, with or without elevated AFP. |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
Funding: none. Conflicts of interest: none 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? |
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? |
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? |
Unclear |
|
|
| Could the reference standard, its conduct, or its interpretation have introduced bias? |
|
Unclear 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 |
|
